Improvement in patient reported symptoms and health related quality of life associated with...
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P6083 Immunomodulatory effect of balneotherapy on imiquimod-induced pso- riasis-like murine model Young Bok Lee, MD, PhD, Department of Dermatology, College of Medicine, The Catholic University of Korea, Uijeongbu, Kyungkido, South Korea; Dong Soo Yu, MD, PhD, Department of Dermatology, College of Medicine, The Catholic University of Korea, Uijeongbu, Kyungkido, South Korea; Hong Jig Kim, Oh & Kim’s Skin, Seoul, South Korea; Jin Wou Kim, MD, PhD, Department of Dermatology, College of Medicine, The Catholic University of Korea, Seoul, Korea; Jun Young Lee, MD, Department of Dermatology, College of Medicine, The Catholic University of Korea, Seoul, Korea; So Youn Woo, Department of Microbiology, School of Medicine, Ewha Woman’s University, Seoul, South Korea Background: Although balneotherapy is not accepted as well-established treatment in dermatology, balneotherapy has been considered to have therapeutic properties for psoriasis and has been widely used as an alternative treatment modality throughout the world. The mechanism for the therapeutic effects of thermomineral water has not been established. Methods: Imiquimod-induced psoriasis-like murine model was used for evaluating the therapeutic effects of balneotherapy with Hae-Un-Dae hot spring mineral water. Clinical improvements were evaluated by a dermatologist who was blind to the grouping of the animals using the clinic photos. The lesional cytokines, including IL- 17A, IL-23, and IL-22, were quantitatively measured by real-time reverse transcrip- tase polymerase chain reaction. The serum levels of cytokine IFN-g, IL-4, IL-5, and IL- 17A were measured by enzyme-linked immunosorbent assay. The T cell proportions in the spleen were evaluated using flow cytometry and histopathologic evaluation were also performed. Results: Comparing with distilled water balneotherapy group, the skin erythema and scale showed faster improvement in mineral water balneotherapy group. The lesional mRNA levels of IL-17A and IL-23 showed substantial reduction in mineral water balneotherapy group. The serum levels of IL-4 and IL-5 significantly decrease in mineral water balneotherapy group, not in distilled water group. The T cell proportion in the spleen showed normalization after balneotherapy. Conclusion: Thermomineral balneotherapy showed immunomodulatory effects in psoriasis like murine model. Mineral water balneotherapy suppressed the lesional IL-23 and IL-17A that are important cytokines in psoriasis. Mineral water balneo- therapy showed therapeutic effects of anti-inflammation that was effective than distilled water balneotherapy. These results suggest that the thermomineral balne- otherapy can be an effective and safe treatment modality in psoriasis. Commercial support: None identified. P6330 Impact of psoriatic arthritis on medical resource use, health status, and work productivity in the United States: 2011 National Health and Wellness Survey results Chureen Carter, PharmD, MS, Janssen Scientific Affairs, LLC, Horsham, PA, United States; Brad Schenkel, MS, Janssen Scientific Affairs, LLC, Horsham, PA, United States; Deborah Freedman, PhD, Kantar Health, New York, NY, United States; Kathy Annunziata, PhD, Kantar Health, New York, NY, United States Background: International data from 1999-2009 demonstrated the association of psoriatic arthritis (PsA) with increased health care resource use and detriments in health status and work productivity. Objective: To compare current medical resource use (MRU), health status, and work productivity among patients with and without PsA in the United States (U.S.). Methods: Data were generated from the National Health and Wellness Survey electronically administered to U.S. adults from January-September 2011. Study participants were self-identified as having physician-diagnosed PsA or not experi- encing arthritis (non-PsA). MRU was evaluated for the 6 months preceding survey participation. Health status was assessed via Short-Form 12 (SF-12) mental and physical summary scores. Work productivity was assessed with a validated scale measuring lost productivity and daily impairment because of disease (Work Productivity and Activity Impairment scale; higher scores indicate greater disease impact). Statistically significant differences were determined with t tests at the 95% confidence level. Results: Data from a total of 185 PsA and 59, 383 non-PsA respondents were assessed. A significantly higher proportion of the PsA group visited general practitioners (GP) or any health care provider (HCP) compared with the non-PsA group (73.7% vs 43.8%, 95.8% vs 69.3%, respectively; both P \.05). PsA patients had a higher mean number of HCP visits compared to non-PsA (7.2 vs 2.9, respectively; P \ .05). Mean physical SF-12 scores were significantly lower for PsA compared with non-PsA (37.5 vs 50.7, respectively; P \ .05), indicating poorer physical health status. No significant between-group differences were found in mental health status scores (46.9 for PsA and 48.3 for non-PsA). Significantly fewer PsA patients were employed full-time (25.8%) compared to non-PsA (41.9%); P \.05. PsA patients had significantly higher mean scores for work impairment, productivity loss, and activity impairment due to the disease than non-PsA (all P \.05). Conclusion: Current U.S. survey findings substantiate PsA’s significant impact on increased outpatient MRU and decreased work productivity. PsA affects physical more than mental summary components. Dermatologists could consider these disease impacts in designing holistic treatment plans. Supported by Janssen Scientific Affairs, LLC. P6613 Improvement in patient reported symptoms and health related quality of life associated with achieving Psoriasis Area and Severity Index 100 Dennis Revicki, PhD, United BioSource Corporation, Bethesda, MD, United States; Dina Chau, Amgen, Thousand Oaks, CA, United States; Hema N. Viswanathan, PhD, Amgen, Thousand Oaks, CA, United States; Joanne Li, Amgen, Thousand Oaks, CA, United States; Ngozi Erondu, Amgen, Thousand Oaks, CA, United States; Ray Hsieh, United BioSource Corporation, Bethesda, MD, United States; Ying Jin, PhD, United BioSource Corporation, Bethesda, MD, United States Objectives: Psoriasis is a symptomatic disease with a significant impact on HRQoL. Evidence on the association between higher levels of skin clearance and HRQoL is limited. This study examined the relationship between achieving higher levels of improvement in PASI and patient reported outcomes (PROs). Methods: Pooled data were used for 186 patients with moderate to severe plaque psoriasis from a phase II clinical trial of brodalumab. Clinical outcomes were measured by 6 discrete ordinal categories of percent improvement in PASI. PROs were measured by the Psoriasis Symptom Inventory (PSI) (24-hour recall and 7-day recall), and the Dermatology Life Quality Index (DLQI). The PSI contains 8 items on psoriasis symptoms and the best possible score of 0 indicates no symptoms. A DLQI score of 0 indicates no impairment in HRQoL. The proportion of subjects achieving PSI ¼ 0, and DLQI ¼ 0 were compared between subjects in the PASI 100 group (N ¼ 56) and the PASI 75 to \90 group (N ¼ 14). Results: The sample was 36% female and 89% Caucasian, with a mean (SD) age of 42.9 (12.2) years. Mean (SD) baseline PASI was 19.3 (6.8). At week 12, median PASI improvement in the PASI 75 to \90 group was PASI 83.6. PSI ¼ 0 (24-hour recall) was achieved by 66% of subjects in the PASI 100 group and 14% of the PASI 75 to \90 group at week 12. Similar rates were seen for the PSI 7-day recall version. DLQI ¼ 0 was achieved by 61% of subjects in the PASI 100 group and 36% in the PASI 75 to \90 group. Conclusion: A significantly higher proportion of subjects with moderate to severe psoriasis achieving a PASI 100 reported no symptoms and no impairment in HRQoL compared to those who achieved a PASI improvement of 75 to \90. Achievement of PASI 100 was not only indicative of total skin clearance but was also accompanied by significant relief in psoriasis symptoms with no impairment in HRQoL. 100% sponsored by Amgen. P6221 Improvement in signs and symptoms of plaque psoriasis after 1 week of treatment with clobetasol propionate 0.05% spray Robert T. Brodell, MD, University of Mississippi Medical Center, Jackson, Mississippi, United States; Norman Preston, PhD, Galderma Laboratories, L.P., Fort Worth, TX, United States Clobetasol propionate 0.05% spray (CPS) is a topical super-high potent corticoste- roid indicated for the treatment of moderate to severe plaque psoriasis. In 2 pivotal trials of CPS, overall disease severity (ODS), erythema, plaque elevation, scaling, and pruritus were assessed on a 5 point scale of 0 (clear) to 4 (severe/very severe) in patients with moderate to severe plaque psoriasis. Treatment success was defined as a score of 0 (clear) or 1 (almost clear). Based on Cochran-Mantel-Haenszel (CMH) analysis, treatment success was achieved in the CPS group in both studies compared to the vehicle group after 2 weeks, but not after 1 week. Because only subjects who were clear or almost clear were considered in the analysis, improvements in other parts of the scale were not examined. When all the data were analyzed using the median as the measure of central tendency, it was shown that ODS, erythema, plaque elevation, scaling and pruritus improved by 1 grade from baseline at week 1 in the CPS treated group (P \.001). This post hoc analysis suggests CPS is effective in ameliorating signs and symptoms of plaque psoriasis after only 1 week of treatment. Supported by Galderma Laboratories, L.P. AB202 JAM ACAD DERMATOL APRIL 2013
Transcript of Improvement in patient reported symptoms and health related quality of life associated with...
P6083Immunomodulatory effect of balneotherapy on imiquimod-induced pso-riasis-like murine model
Young Bok Lee, MD, PhD, Department of Dermatology, College of Medicine, TheCatholic University of Korea, Uijeongbu, Kyungkido, South Korea; Dong Soo Yu,MD, PhD, Department of Dermatology, College of Medicine, The CatholicUniversity of Korea, Uijeongbu, Kyungkido, South Korea; Hong Jig Kim, Oh &Kim’s Skin, Seoul, South Korea; Jin Wou Kim, MD, PhD, Department ofDermatology, College of Medicine, The Catholic University of Korea, Seoul,Korea; Jun Young Lee, MD, Department of Dermatology, College of Medicine,The Catholic University of Korea, Seoul, Korea; So Youn Woo, Department ofMicrobiology, School of Medicine, Ewha Woman’s University, Seoul, South Korea
Background: Although balneotherapy is not accepted as well-established treatmentin dermatology, balneotherapy has been considered to have therapeutic propertiesfor psoriasis and has been widely used as an alternative treatment modalitythroughout the world. The mechanism for the therapeutic effects of thermomineralwater has not been established.
Methods: Imiquimod-induced psoriasis-like murine model was used for evaluatingthe therapeutic effects of balneotherapy with Hae-Un-Dae hot spring mineral water.Clinical improvements were evaluated by a dermatologist who was blind to thegrouping of the animals using the clinic photos. The lesional cytokines, including IL-17A, IL-23, and IL-22, were quantitatively measured by real-time reverse transcrip-tase polymerase chain reaction. The serum levels of cytokine IFN-g, IL-4, IL-5, and IL-17Awere measured by enzyme-linked immunosorbent assay. The T cell proportionsin the spleen were evaluated using flow cytometry and histopathologic evaluationwere also performed.
Results: Comparing with distilled water balneotherapy group, the skin erythemaand scale showed faster improvement in mineral water balneotherapy group. Thelesional mRNA levels of IL-17A and IL-23 showed substantial reduction in mineralwater balneotherapy group. The serum levels of IL-4 and IL-5 significantly decreasein mineral water balneotherapy group, not in distilled water group. The T cellproportion in the spleen showed normalization after balneotherapy.
Conclusion: Thermomineral balneotherapy showed immunomodulatory effects inpsoriasis like murine model. Mineral water balneotherapy suppressed the lesionalIL-23 and IL-17A that are important cytokines in psoriasis. Mineral water balneo-therapy showed therapeutic effects of anti-inflammation that was effective thandistilled water balneotherapy. These results suggest that the thermomineral balne-otherapy can be an effective and safe treatment modality in psoriasis.
AB202
cial support: None identified.
CommerP6330Impact of psoriatic arthritis on medical resource use, health status, andwork productivity in the United States: 2011 National Health and WellnessSurvey results
Chureen Carter, PharmD, MS, Janssen Scientific Affairs, LLC, Horsham, PA,United States; Brad Schenkel, MS, Janssen Scientific Affairs, LLC, Horsham, PA,United States; Deborah Freedman, PhD, Kantar Health, New York, NY, UnitedStates; Kathy Annunziata, PhD, Kantar Health, New York, NY, United States
Background: International data from 1999-2009 demonstrated the association ofpsoriatic arthritis (PsA) with increased health care resource use and detriments inhealth status and work productivity.
Objective: To compare current medical resource use (MRU), health status, and workproductivity among patients with and without PsA in the United States (U.S.).
Methods: Data were generated from the National Health and Wellness Surveyelectronically administered to U.S. adults from January-September 2011. Studyparticipants were self-identified as having physician-diagnosed PsA or not experi-encing arthritis (non-PsA). MRU was evaluated for the 6 months preceding surveyparticipation. Health status was assessed via Short-Form 12 (SF-12) mental andphysical summary scores. Work productivity was assessed with a validated scalemeasuring lost productivity and daily impairment because of disease (WorkProductivity and Activity Impairment scale; higher scores indicate greater diseaseimpact). Statistically significant differences were determined with t tests at the 95%confidence level.
Results: Data from a total of 185 PsA and 59, 383 non-PsA respondents wereassessed. A significantly higher proportion of the PsA group visited generalpractitioners (GP) or any health care provider (HCP) compared with the non-PsAgroup (73.7% vs 43.8%, 95.8% vs 69.3%, respectively; both P\.05). PsA patients hada higher mean number of HCP visits compared to non-PsA (7.2 vs 2.9, respectively; P\ .05). Mean physical SF-12 scores were significantly lower for PsA compared withnon-PsA (37.5 vs 50.7, respectively; P \ .05), indicating poorer physical healthstatus. No significant between-group differences were found in mental health statusscores (46.9 for PsA and 48.3 for non-PsA). Significantly fewer PsA patients wereemployed full-time (25.8%) compared to non-PsA (41.9%); P\.05. PsA patients hadsignificantly higher mean scores for work impairment, productivity loss, and activityimpairment due to the disease than non-PsA (all P\.05).
Conclusion: Current U.S. survey findings substantiate PsA’s significant impact onincreased outpatient MRU and decreased work productivity. PsA affects physicalmore than mental summary components. Dermatologists could consider thesedisease impacts in designing holistic treatment plans.
d by Janssen Scientific Affairs, LLC.
SupporteJ AM ACAD DERMATOL
P6613Improvement in patient reported symptoms and health related quality oflife associated with achieving Psoriasis Area and Severity Index 100
Dennis Revicki, PhD, United BioSource Corporation, Bethesda, MD, UnitedStates; Dina Chau, Amgen, Thousand Oaks, CA, United States; Hema N.Viswanathan, PhD, Amgen, Thousand Oaks, CA, United States; Joanne Li,Amgen, Thousand Oaks, CA, United States; Ngozi Erondu, Amgen, ThousandOaks, CA, United States; Ray Hsieh, United BioSource Corporation, Bethesda,MD, United States; Ying Jin, PhD, United BioSource Corporation, Bethesda, MD,United States
Objectives: Psoriasis is a symptomatic disease with a significant impact on HRQoL.Evidence on the association between higher levels of skin clearance and HRQoL islimited. This study examined the relationship between achieving higher levels ofimprovement in PASI and patient reported outcomes (PROs).
Methods: Pooled data were used for 186 patients with moderate to severe plaquepsoriasis from a phase II clinical trial of brodalumab. Clinical outcomes weremeasured by 6 discrete ordinal categories of percent improvement in PASI. PROswere measured by the Psoriasis Symptom Inventory (PSI) (24-hour recall and 7-dayrecall), and the Dermatology Life Quality Index (DLQI). The PSI contains 8 items onpsoriasis symptoms and the best possible score of 0 indicates no symptoms. A DLQIscore of 0 indicates no impairment in HRQoL. The proportion of subjects achievingPSI¼ 0, and DLQI¼ 0 were compared between subjects in the PASI 100 group (N¼56) and the PASI 75 to\90 group (N ¼ 14).
Results: The sample was 36% female and 89% Caucasian, with a mean (SD) age of42.9 (12.2) years. Mean (SD) baseline PASI was 19.3 (6.8). At week 12, median PASIimprovement in the PASI 75 to\90 group was PASI 83.6. PSI ¼ 0 (24-hour recall)was achieved by 66% of subjects in the PASI 100 group and 14% of the PASI 75 to\90group at week 12. Similar rates were seen for the PSI 7-day recall version. DLQI ¼ 0was achieved by 61% of subjects in the PASI 100 group and 36% in the PASI 75 to\90group.
Conclusion: A significantly higher proportion of subjects with moderate to severepsoriasis achieving a PASI 100 reported no symptoms and no impairment in HRQoLcompared to those who achieved a PASI improvement of 75 to\90. Achievement ofPASI 100was not only indicative of total skin clearance but was also accompanied bysignificant relief in psoriasis symptoms with no impairment in HRQoL.
nsored by Amgen.
100% spoP6221Improvement in signs and symptoms of plaque psoriasis after 1 week oftreatment with clobetasol propionate 0.05% spray
Robert T. Brodell, MD, University of Mississippi Medical Center, Jackson,Mississippi, United States; Norman Preston, PhD, Galderma Laboratories, L.P.,Fort Worth, TX, United States
Clobetasol propionate 0.05% spray (CPS) is a topical super-high potent corticoste-roid indicated for the treatment of moderate to severe plaque psoriasis. In 2 pivotaltrials of CPS, overall disease severity (ODS), erythema, plaque elevation, scaling, andpruritus were assessed on a 5 point scale of 0 (clear) to 4 (severe/very severe) inpatients with moderate to severe plaque psoriasis. Treatment success was defined asa score of 0 (clear) or 1 (almost clear). Based on Cochran-Mantel-Haenszel (CMH)analysis, treatment success was achieved in the CPS group in both studies comparedto the vehicle group after 2 weeks, but not after 1 week. Because only subjects whowere clear or almost clear were considered in the analysis, improvements in otherparts of the scale were not examined. When all the data were analyzed using themedian as the measure of central tendency, it was shown that ODS, erythema,plaque elevation, scaling and pruritus improved by 1 grade from baseline at week1 in the CPS treated group (P\.001). This post hoc analysis suggests CPS is effectivein ameliorating signs and symptoms of plaque psoriasis after only 1 week oftreatment.
d by Galderma Laboratories, L.P.
SupporteAPRIL 2013
