Targeting grossly elevated IgE: a novel therapeutic option in severe patients
37
Targeting grossly elevated IgE: a novel therapeutic option in severe patients Markus Ollert, MD Professor of Molecular Dermatology and Immunology Department of Dermatology and Allergy Clinical Research Group of Molecular Dermatology and Immunology/ZAUM Klinikum rechts der Isar, Technische Universität München (TUM) and Helmholtz Center Munich for Environmental Health, Munich, Germany Session „Dermatitis Atopica“, XVII Congreso SLaai, Cartagena, Colombia, 25 October 2012
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Markus Ollert, MD. Conferencia dictada en el XVII Congreso Latinoamericano de Alergia, Asma e Inmunología, Cartagena, 2012
Transcript of Targeting grossly elevated IgE: a novel therapeutic option in severe patients
Targeting grossly elevated IgE a novel therapeutic option in severe patients
Markus Ollert MD
Professor of Molecular Dermatology and Immunology
Department of Dermatology and Allergy
Clinical Research Group of Molecular Dermatology and ImmunologyZAUM
Klinikum rechts der Isar Technische Universitaumlt Muumlnchen (TUM) and Helmholtz Center Munich for Environmental Health Munich Germany
Session bdquoDermatitis Atopicaldquo XVII Congreso SLaai Cartagena Colombia 25 October 2012
bull Inflammatory chronically relapsing non-contagious and pruritic skin disorder
bull Known since ancient times
Robert Willan Delineations of
Cutaneous Diseases 1817 Bieber T N Engl J Med 2008 3581483-1494
Atopic Eczema Dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Inflammatory chronically relapsing non-contagious and pruritic skin disorder
bull Known since ancient times bull Up to 10 of adults in
industrialized countries are affected
bull Especially for severe cases no
satisfactory treatment option is available until today
Bieber T N Engl J Med 2008 3581483-1494
Atopic Eczema Dermatitis
Technische
Universitaumlt
Muumlnchen
0
5
10
15
20
25
30
1946
1958
1964
1968
1970
1971
1974
1979
1981
1985
1986
1989
1991
1992
1993
1994
1997
1999
2000
Taylor UK
Ninan UK
Schultz-L DK
Varonier CH
Aberg S
Eaton UK
Austin UK
Butland UK
Yura J
Heinrich J
Schaumlfer D
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Total IgE levels (UmL) of gt1000 ndash 100000 are common in adult patients
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
House dust mite
(Encasing SIT)
Food allergens
(Elimination cowacutes milk
henacutes egg wheat nuts)
Inhalant allergens
(SIT with pollen extract)
S aureus antigens
(SEA SEB FN-BP)
Malassezia sympodialis
(Mala s 1-6)
Autoallergy
(Hom s 1-4)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Targeting IgE antibodies ndash
A universal therapeutic solution for allergic atopic disorders with ldquohigh IgE phenotypesrdquo such as atopic dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
The pathogenetic role of IgE in atopic dermatitis a highly controversial issue Off-label use of anti-IgE antibody omalizumab in atopic dermatitis very ambivalent results
Belloni B et al JACI 2007 120 1223-1225
Bieber T N Engl J Med 2008 358 1483-1494
Heil PM et al JDDG 2010 8 990-998
Patient A IgE = 12534 kUL
IgE and Atopic Dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Patient A IgE = 12534 kUL
Omalizumab
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Table 2 Pharmacotherapy on first presentation in our outpatient clinic
Agent Daily dose
Fluticasone salmeterol 500 microg 50 microg bid per DPI (Diskusreg)
Formoterol 12 microg per pMDI
Prednisolone 50 mg po
Omeprazole 20 mg po
Montelukast 10 mg po
Ipratropiumbromide fenoterol 20 microg 50 microg prn per pMDI
(was actually used 10 ndash 12 times a day)
Cetirizine 10 mg po
NaCl 09 2 ml tid per nebulizer
DPI dry powder inhaler pMDI pressurized metered dose inhaler
Case Report 15-Year-Old Patient with Severe Asthma
Kerzel et al Klin Padiatr 2011223356-359
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Table 1 Relevant laboratory findings before plasmapheresis
Actual value Reference range
total IgE 4170 kUl [lt 100 kUl]
specific IgE against
phleum pratense
35 kUl [lt 035 kUl]
rye pollen 25 kUl [lt 035 kUl]
cat 209 kUl [lt 035 kUl]
dog 186 kUl [lt 035 kUl]
leukocytes 114 Gl [45 ndash 10 Gl]
eosinophils 22 [1 ndash 4]
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Inflammatory chronically relapsing non-contagious and pruritic skin disorder
bull Known since ancient times
Robert Willan Delineations of
Cutaneous Diseases 1817 Bieber T N Engl J Med 2008 3581483-1494
Atopic Eczema Dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Inflammatory chronically relapsing non-contagious and pruritic skin disorder
bull Known since ancient times bull Up to 10 of adults in
industrialized countries are affected
bull Especially for severe cases no
satisfactory treatment option is available until today
Bieber T N Engl J Med 2008 3581483-1494
Atopic Eczema Dermatitis
Technische
Universitaumlt
Muumlnchen
0
5
10
15
20
25
30
1946
1958
1964
1968
1970
1971
1974
1979
1981
1985
1986
1989
1991
1992
1993
1994
1997
1999
2000
Taylor UK
Ninan UK
Schultz-L DK
Varonier CH
Aberg S
Eaton UK
Austin UK
Butland UK
Yura J
Heinrich J
Schaumlfer D
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Total IgE levels (UmL) of gt1000 ndash 100000 are common in adult patients
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
House dust mite
(Encasing SIT)
Food allergens
(Elimination cowacutes milk
henacutes egg wheat nuts)
Inhalant allergens
(SIT with pollen extract)
S aureus antigens
(SEA SEB FN-BP)
Malassezia sympodialis
(Mala s 1-6)
Autoallergy
(Hom s 1-4)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Targeting IgE antibodies ndash
A universal therapeutic solution for allergic atopic disorders with ldquohigh IgE phenotypesrdquo such as atopic dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
The pathogenetic role of IgE in atopic dermatitis a highly controversial issue Off-label use of anti-IgE antibody omalizumab in atopic dermatitis very ambivalent results
Belloni B et al JACI 2007 120 1223-1225
Bieber T N Engl J Med 2008 358 1483-1494
Heil PM et al JDDG 2010 8 990-998
Patient A IgE = 12534 kUL
IgE and Atopic Dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Patient A IgE = 12534 kUL
Omalizumab
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Table 2 Pharmacotherapy on first presentation in our outpatient clinic
Agent Daily dose
Fluticasone salmeterol 500 microg 50 microg bid per DPI (Diskusreg)
Formoterol 12 microg per pMDI
Prednisolone 50 mg po
Omeprazole 20 mg po
Montelukast 10 mg po
Ipratropiumbromide fenoterol 20 microg 50 microg prn per pMDI
(was actually used 10 ndash 12 times a day)
Cetirizine 10 mg po
NaCl 09 2 ml tid per nebulizer
DPI dry powder inhaler pMDI pressurized metered dose inhaler
Case Report 15-Year-Old Patient with Severe Asthma
Kerzel et al Klin Padiatr 2011223356-359
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Table 1 Relevant laboratory findings before plasmapheresis
Actual value Reference range
total IgE 4170 kUl [lt 100 kUl]
specific IgE against
phleum pratense
35 kUl [lt 035 kUl]
rye pollen 25 kUl [lt 035 kUl]
cat 209 kUl [lt 035 kUl]
dog 186 kUl [lt 035 kUl]
leukocytes 114 Gl [45 ndash 10 Gl]
eosinophils 22 [1 ndash 4]
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Inflammatory chronically relapsing non-contagious and pruritic skin disorder
bull Known since ancient times bull Up to 10 of adults in
industrialized countries are affected
bull Especially for severe cases no
satisfactory treatment option is available until today
Bieber T N Engl J Med 2008 3581483-1494
Atopic Eczema Dermatitis
Technische
Universitaumlt
Muumlnchen
0
5
10
15
20
25
30
1946
1958
1964
1968
1970
1971
1974
1979
1981
1985
1986
1989
1991
1992
1993
1994
1997
1999
2000
Taylor UK
Ninan UK
Schultz-L DK
Varonier CH
Aberg S
Eaton UK
Austin UK
Butland UK
Yura J
Heinrich J
Schaumlfer D
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Total IgE levels (UmL) of gt1000 ndash 100000 are common in adult patients
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
House dust mite
(Encasing SIT)
Food allergens
(Elimination cowacutes milk
henacutes egg wheat nuts)
Inhalant allergens
(SIT with pollen extract)
S aureus antigens
(SEA SEB FN-BP)
Malassezia sympodialis
(Mala s 1-6)
Autoallergy
(Hom s 1-4)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Targeting IgE antibodies ndash
A universal therapeutic solution for allergic atopic disorders with ldquohigh IgE phenotypesrdquo such as atopic dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
The pathogenetic role of IgE in atopic dermatitis a highly controversial issue Off-label use of anti-IgE antibody omalizumab in atopic dermatitis very ambivalent results
Belloni B et al JACI 2007 120 1223-1225
Bieber T N Engl J Med 2008 358 1483-1494
Heil PM et al JDDG 2010 8 990-998
Patient A IgE = 12534 kUL
IgE and Atopic Dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Patient A IgE = 12534 kUL
Omalizumab
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Table 2 Pharmacotherapy on first presentation in our outpatient clinic
Agent Daily dose
Fluticasone salmeterol 500 microg 50 microg bid per DPI (Diskusreg)
Formoterol 12 microg per pMDI
Prednisolone 50 mg po
Omeprazole 20 mg po
Montelukast 10 mg po
Ipratropiumbromide fenoterol 20 microg 50 microg prn per pMDI
(was actually used 10 ndash 12 times a day)
Cetirizine 10 mg po
NaCl 09 2 ml tid per nebulizer
DPI dry powder inhaler pMDI pressurized metered dose inhaler
Case Report 15-Year-Old Patient with Severe Asthma
Kerzel et al Klin Padiatr 2011223356-359
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Table 1 Relevant laboratory findings before plasmapheresis
Actual value Reference range
total IgE 4170 kUl [lt 100 kUl]
specific IgE against
phleum pratense
35 kUl [lt 035 kUl]
rye pollen 25 kUl [lt 035 kUl]
cat 209 kUl [lt 035 kUl]
dog 186 kUl [lt 035 kUl]
leukocytes 114 Gl [45 ndash 10 Gl]
eosinophils 22 [1 ndash 4]
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Total IgE levels (UmL) of gt1000 ndash 100000 are common in adult patients
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
House dust mite
(Encasing SIT)
Food allergens
(Elimination cowacutes milk
henacutes egg wheat nuts)
Inhalant allergens
(SIT with pollen extract)
S aureus antigens
(SEA SEB FN-BP)
Malassezia sympodialis
(Mala s 1-6)
Autoallergy
(Hom s 1-4)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Targeting IgE antibodies ndash
A universal therapeutic solution for allergic atopic disorders with ldquohigh IgE phenotypesrdquo such as atopic dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
The pathogenetic role of IgE in atopic dermatitis a highly controversial issue Off-label use of anti-IgE antibody omalizumab in atopic dermatitis very ambivalent results
Belloni B et al JACI 2007 120 1223-1225
Bieber T N Engl J Med 2008 358 1483-1494
Heil PM et al JDDG 2010 8 990-998
Patient A IgE = 12534 kUL
IgE and Atopic Dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Patient A IgE = 12534 kUL
Omalizumab
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Table 2 Pharmacotherapy on first presentation in our outpatient clinic
Agent Daily dose
Fluticasone salmeterol 500 microg 50 microg bid per DPI (Diskusreg)
Formoterol 12 microg per pMDI
Prednisolone 50 mg po
Omeprazole 20 mg po
Montelukast 10 mg po
Ipratropiumbromide fenoterol 20 microg 50 microg prn per pMDI
(was actually used 10 ndash 12 times a day)
Cetirizine 10 mg po
NaCl 09 2 ml tid per nebulizer
DPI dry powder inhaler pMDI pressurized metered dose inhaler
Case Report 15-Year-Old Patient with Severe Asthma
Kerzel et al Klin Padiatr 2011223356-359
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Table 1 Relevant laboratory findings before plasmapheresis
Actual value Reference range
total IgE 4170 kUl [lt 100 kUl]
specific IgE against
phleum pratense
35 kUl [lt 035 kUl]
rye pollen 25 kUl [lt 035 kUl]
cat 209 kUl [lt 035 kUl]
dog 186 kUl [lt 035 kUl]
leukocytes 114 Gl [45 ndash 10 Gl]
eosinophils 22 [1 ndash 4]
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
House dust mite
(Encasing SIT)
Food allergens
(Elimination cowacutes milk
henacutes egg wheat nuts)
Inhalant allergens
(SIT with pollen extract)
S aureus antigens
(SEA SEB FN-BP)
Malassezia sympodialis
(Mala s 1-6)
Autoallergy
(Hom s 1-4)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Targeting IgE antibodies ndash
A universal therapeutic solution for allergic atopic disorders with ldquohigh IgE phenotypesrdquo such as atopic dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
The pathogenetic role of IgE in atopic dermatitis a highly controversial issue Off-label use of anti-IgE antibody omalizumab in atopic dermatitis very ambivalent results
Belloni B et al JACI 2007 120 1223-1225
Bieber T N Engl J Med 2008 358 1483-1494
Heil PM et al JDDG 2010 8 990-998
Patient A IgE = 12534 kUL
IgE and Atopic Dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Patient A IgE = 12534 kUL
Omalizumab
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Table 2 Pharmacotherapy on first presentation in our outpatient clinic
Agent Daily dose
Fluticasone salmeterol 500 microg 50 microg bid per DPI (Diskusreg)
Formoterol 12 microg per pMDI
Prednisolone 50 mg po
Omeprazole 20 mg po
Montelukast 10 mg po
Ipratropiumbromide fenoterol 20 microg 50 microg prn per pMDI
(was actually used 10 ndash 12 times a day)
Cetirizine 10 mg po
NaCl 09 2 ml tid per nebulizer
DPI dry powder inhaler pMDI pressurized metered dose inhaler
Case Report 15-Year-Old Patient with Severe Asthma
Kerzel et al Klin Padiatr 2011223356-359
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Table 1 Relevant laboratory findings before plasmapheresis
Actual value Reference range
total IgE 4170 kUl [lt 100 kUl]
specific IgE against
phleum pratense
35 kUl [lt 035 kUl]
rye pollen 25 kUl [lt 035 kUl]
cat 209 kUl [lt 035 kUl]
dog 186 kUl [lt 035 kUl]
leukocytes 114 Gl [45 ndash 10 Gl]
eosinophils 22 [1 ndash 4]
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Targeting IgE antibodies ndash
A universal therapeutic solution for allergic atopic disorders with ldquohigh IgE phenotypesrdquo such as atopic dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
The pathogenetic role of IgE in atopic dermatitis a highly controversial issue Off-label use of anti-IgE antibody omalizumab in atopic dermatitis very ambivalent results
Belloni B et al JACI 2007 120 1223-1225
Bieber T N Engl J Med 2008 358 1483-1494
Heil PM et al JDDG 2010 8 990-998
Patient A IgE = 12534 kUL
IgE and Atopic Dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Patient A IgE = 12534 kUL
Omalizumab
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Table 2 Pharmacotherapy on first presentation in our outpatient clinic
Agent Daily dose
Fluticasone salmeterol 500 microg 50 microg bid per DPI (Diskusreg)
Formoterol 12 microg per pMDI
Prednisolone 50 mg po
Omeprazole 20 mg po
Montelukast 10 mg po
Ipratropiumbromide fenoterol 20 microg 50 microg prn per pMDI
(was actually used 10 ndash 12 times a day)
Cetirizine 10 mg po
NaCl 09 2 ml tid per nebulizer
DPI dry powder inhaler pMDI pressurized metered dose inhaler
Case Report 15-Year-Old Patient with Severe Asthma
Kerzel et al Klin Padiatr 2011223356-359
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Table 1 Relevant laboratory findings before plasmapheresis
Actual value Reference range
total IgE 4170 kUl [lt 100 kUl]
specific IgE against
phleum pratense
35 kUl [lt 035 kUl]
rye pollen 25 kUl [lt 035 kUl]
cat 209 kUl [lt 035 kUl]
dog 186 kUl [lt 035 kUl]
leukocytes 114 Gl [45 ndash 10 Gl]
eosinophils 22 [1 ndash 4]
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
The pathogenetic role of IgE in atopic dermatitis a highly controversial issue Off-label use of anti-IgE antibody omalizumab in atopic dermatitis very ambivalent results
Belloni B et al JACI 2007 120 1223-1225
Bieber T N Engl J Med 2008 358 1483-1494
Heil PM et al JDDG 2010 8 990-998
Patient A IgE = 12534 kUL
IgE and Atopic Dermatitis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Patient A IgE = 12534 kUL
Omalizumab
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Table 2 Pharmacotherapy on first presentation in our outpatient clinic
Agent Daily dose
Fluticasone salmeterol 500 microg 50 microg bid per DPI (Diskusreg)
Formoterol 12 microg per pMDI
Prednisolone 50 mg po
Omeprazole 20 mg po
Montelukast 10 mg po
Ipratropiumbromide fenoterol 20 microg 50 microg prn per pMDI
(was actually used 10 ndash 12 times a day)
Cetirizine 10 mg po
NaCl 09 2 ml tid per nebulizer
DPI dry powder inhaler pMDI pressurized metered dose inhaler
Case Report 15-Year-Old Patient with Severe Asthma
Kerzel et al Klin Padiatr 2011223356-359
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Table 1 Relevant laboratory findings before plasmapheresis
Actual value Reference range
total IgE 4170 kUl [lt 100 kUl]
specific IgE against
phleum pratense
35 kUl [lt 035 kUl]
rye pollen 25 kUl [lt 035 kUl]
cat 209 kUl [lt 035 kUl]
dog 186 kUl [lt 035 kUl]
leukocytes 114 Gl [45 ndash 10 Gl]
eosinophils 22 [1 ndash 4]
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Patient A IgE = 12534 kUL
Omalizumab
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Table 2 Pharmacotherapy on first presentation in our outpatient clinic
Agent Daily dose
Fluticasone salmeterol 500 microg 50 microg bid per DPI (Diskusreg)
Formoterol 12 microg per pMDI
Prednisolone 50 mg po
Omeprazole 20 mg po
Montelukast 10 mg po
Ipratropiumbromide fenoterol 20 microg 50 microg prn per pMDI
(was actually used 10 ndash 12 times a day)
Cetirizine 10 mg po
NaCl 09 2 ml tid per nebulizer
DPI dry powder inhaler pMDI pressurized metered dose inhaler
Case Report 15-Year-Old Patient with Severe Asthma
Kerzel et al Klin Padiatr 2011223356-359
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Table 1 Relevant laboratory findings before plasmapheresis
Actual value Reference range
total IgE 4170 kUl [lt 100 kUl]
specific IgE against
phleum pratense
35 kUl [lt 035 kUl]
rye pollen 25 kUl [lt 035 kUl]
cat 209 kUl [lt 035 kUl]
dog 186 kUl [lt 035 kUl]
leukocytes 114 Gl [45 ndash 10 Gl]
eosinophils 22 [1 ndash 4]
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Table 2 Pharmacotherapy on first presentation in our outpatient clinic
Agent Daily dose
Fluticasone salmeterol 500 microg 50 microg bid per DPI (Diskusreg)
Formoterol 12 microg per pMDI
Prednisolone 50 mg po
Omeprazole 20 mg po
Montelukast 10 mg po
Ipratropiumbromide fenoterol 20 microg 50 microg prn per pMDI
(was actually used 10 ndash 12 times a day)
Cetirizine 10 mg po
NaCl 09 2 ml tid per nebulizer
DPI dry powder inhaler pMDI pressurized metered dose inhaler
Case Report 15-Year-Old Patient with Severe Asthma
Kerzel et al Klin Padiatr 2011223356-359
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Table 1 Relevant laboratory findings before plasmapheresis
Actual value Reference range
total IgE 4170 kUl [lt 100 kUl]
specific IgE against
phleum pratense
35 kUl [lt 035 kUl]
rye pollen 25 kUl [lt 035 kUl]
cat 209 kUl [lt 035 kUl]
dog 186 kUl [lt 035 kUl]
leukocytes 114 Gl [45 ndash 10 Gl]
eosinophils 22 [1 ndash 4]
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Table 1 Relevant laboratory findings before plasmapheresis
Actual value Reference range
total IgE 4170 kUl [lt 100 kUl]
specific IgE against
phleum pratense
35 kUl [lt 035 kUl]
rye pollen 25 kUl [lt 035 kUl]
cat 209 kUl [lt 035 kUl]
dog 186 kUl [lt 035 kUl]
leukocytes 114 Gl [45 ndash 10 Gl]
eosinophils 22 [1 ndash 4]
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
0 24 480
1000
2000
3000
4000
5000
200 700
IgE
80 kUl
2300 kUl free IgE
start omalizumab
plasma-pheresis
plasma-pheresis
plasma-pheresis
hour
kU
l
Figure 1 Dynamics of serum IgE during and after plasma exchange
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0 100 200 3000
100
200
300
4002000
3000
4000
5000
total IgE
free IgE
start omalizumabday
kU
lFigure 2 Dynamics of total IgE and free IgE during omalizumab therapy
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
-50 0 50 100 15040
60
80
100100
150
200
250
300
SR
FEV1
days
p
red
icte
d
plasmapheresis
omalizumab
Figure 3 Lung function before and after plasmapheresis
High IgE Asthma Phenotype Therapy with Plasmapheresis and Anti-IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Kerzel et al Klin Padiatr 2011223356-359
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Targeting IgE antibodies ndash
Can we apply an IgE-directed treatment regimen to atopic dermatitis with ldquohigh
IgE phenotyperdquo
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Investigator-initiated pilot study
Investigator-initiated open-label clinical pilot trial approved by ethics committee
government agencies and European Medicines Agency (EMA) (EudraCT 2009- 014582-51)
10 patients with severe therapy refractory atopic dermatitis and grossly elevated total IgE-levels ranging from 3728 kUL to 69972 kUL
Initial immunoadsorption prior to administration of anti-IgE-antibody omalizumab for 6 months and a 6 months follow-up
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-Apheresis
2-4 days
Tx with Anti-IgE (Omalizumab)
450 mg sc bi-weekly
24 weeks
Control periodFollow-up
24 weeks
Primary endpoint long-term control of free IgE levels (lt150 lt1000 kUL) Secondary endpoints - severity of AD (rated by SCORAD) - TARC (CCL 17) levels in serum - patientrsquos personal evaluation on severity and pruritus scale - standardized photography Sponsor Klinikum rechts der IsarTUM Support Miltenyi Biotec (supply and materials for Therasorb Ig-apheresis)
Investigator-initiated pilot study
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Conventional plasmapheresis Immune apheresis (Immune adsorption)
Technische
Universitaumlt
Muumlnchen
Ig-binding specificitycapacity of the
TheraSorb system IgG gt IgM gt IgE
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Ig-binding specificitycapacity of other
available systems IgG gt IgM gtgtgt IgE
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Immunoadsorption with TheraSorbtrade
Tolerated very well by all patients without any noteworthy side effects
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during immunoadsorption
0
20
40
60
80
100
120
beofore IA1 IA1 IA2 IA3 IA4
IgE
IgE during immunoadsorption
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Paitent 9
Patient 10
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
13000
14000
15000
1 = nach IA
3 5 7 9 11 13
fre
e Ig
E in
IUm
l
week
Free IgE in the course of study
Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Patient 9
Patient 10
Free IgE levels continued to drop during OMZ therapy reaching free IgE-levels of lt150 kUL in 510 and lt1000 kUL in 910 patients during the entire treatment period of 24 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
IgE during omalizumab ndash first 12 weeks
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Control of pruritus and visual analogue scale
(subjective patient score)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD (disease activity)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12-25 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD ndash first 12 weeks of IIT
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
SCORAD IgE TARC (entire study period)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000 free IgE in kUL
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
0
2000
4000
6000
8000
10000
12000
14000
0
10
20
30
40
50
60
70
80
week 1 week 3 week 13 week 25 week 49
SCORAD
free IgE in kUL
SCORAD
SCORAD and IgE
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
fIgE
End of OMZ Tx
Immune
apheresis
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
1000
1200
1400
1600
1800
2000
2200
2400
2600
2800
week 1 week 3 week 13 week 25 week 49
TARC (CCL 17) pgml
TARC Levels
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein End of OMZ Tx
Immune
apheresis
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
week 1 week 3 week 13 week 25 week 49
Clinical Phenotype
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
End of OMZ Tx
Immune
apheresis
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Consumption of topical medication (up to week 12)
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Immunoadsorption prior to omalizumab is suitable to
reduce highly elevated serum IgE levels and may
improve clinical symptoms of atopic dermatitis
bull Further studies regarding IgE control in atopic dermatitis
are justified and needed due to the given limitations of
our pilot study
bull Targeting IgE by apheresis a promising treatment option
in severely diseased patients with bdquohigh IgE phenotypeldquo
Conclusion
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
bull Placebo-controlled double-blind crossover study
Future studies
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
Technische
Universitaumlt
Muumlnchen
Muchas gracias por su atencioacuten
OLLERTLRZTUMDE Klinik und Poliklinik fuumlr Dermatologie
und Allergologie
am Biederstein
