Treatment of pityriasis rubra pilaris with ustekinumab
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P6429 Tolerability of ustekinumab in psoriasis of moderate to high degree associated to Berger disease Rosalba Buquicchio, Bari, Italy; Antonio Carpentieri, Taranto, Italy; Francesco Loconsole, Bari, Italy; Piergiorgio Malagoli, Milan, Italy We here relate our clinical experience using a biologic therapy with ‘‘monoclonal antibodies directed against interleukin’’ on 3 patients affected by severe psoriasis, complicated by Berger disease. We observed 3 male patients, aged 35 to 50, affected by moderate to severe psoriasis. All 3 patients could not be treated with traditional systemic therapies becuase they were also affected by Berger disease. The diagnosis of Berger disease was confirmed by renal biopsy and histologic examination, that revealed the presence of IgA deposits mainly in the renal glomerulus. After ascertaining the suitability of the 3 patients for biologic therapy through screenings, we performed a nephrologic consultation, evaluating the dosages of proetinuria within the 24 hours, creatinuria and creatine clearance. In all 3 patients, pretreat- ment laboratory examinations revealed the presence of proteins in the urine and slightly higher levels of creatininemia. After 3 months from the beginning of the treatment, we repeated a dosage of the same parameters, observing the persistency of proteinuria with values not exceeding the previous ones, while the values of creatininemia and creatine clearance overlapped with the previous ones. We also observed a significant improvement of psoriasis lesions. Clinically, we recorded the reaching of PASI 75 after 12 weeks of treatment. Throughout the therapy, we recorded no adverse reactions in the 3 patients, nor a worsening in renal function. An interesting outcome was the disappearance of proteinuria after 3 months of treatment in 1 of the 3 patients, with a persistence of such an outcome in the subsequent check-ups within 6 and 12 months. The drug proved effective and was well tolerated by all 3 patients. It did not cause a worsening in the basic comorbidity, in fact, quite the contrary: in 1 case we observed the normalization of a renal function parameter. Presently, the 3 patients are still responding to the therapy with PASI 75 and are under scrutiny for renal function with check-ups every 3 months. Commercial support: None identified. P6043 Treatment of pityriasis rubra pilaris with ustekinumab Sara Fitz, MD, University of Wisconsin, Department of Dermatology, Madison, WI, United States; B. Jack Longley, MD, University of Wisconsin, Department of Dermatology, Madison, WI, United States; David Puchalsky, University of Wisconsin, Department of Dermatology, Madison, WI, United States Pityriasis rubra pilaris (PRP) is a papulosquamous disease that is characterized by follicular hyperkeratotic papules which coalesce into plaques with an orange hue and distinctive ‘‘islands of sparing.’’ First-line therapies are often oral retinoids and/or methotrexate. Case reports and case series have reported success with azathioprine, cyclosporine, and tumor necrosis factor alpha inhibitors. Our patient, a 47-year-old man with a 10-year history of PRP, presented after failing to achieve a satisfactory response to many treatments, including topical steroids, acitretin, methotrexate, adalimumab, cyclosporine, and narrowband ultraviolet light therapy. The patient was started on ustekinumab, an IL-12/23 inhibitor approved for psoriasis, and showed substantial improvement within four weeks of initiation. He has been maintained on this with satisfactory treatment for the past year. This case reports suggests, as do several others now in the literature, that treatment with ustekinumab should be considered as a treatment option in patients with PRP. Commercial support: None identified. P7008 Treatment of refractory pityriasis rubra pilaris with etanercept Alberto Conde-Taboada, Dermatology Department. Hospital Cl ınico San Carlos, Madrid, Spain; Alejandro Fueyo, Dermatology Department, Hospital Cl ınico San Carlos, Madrid, Spain; Eduardo L opez-Bran, Dermatology Department, Hospital Cl ınico San Carlos, Madrid, Spain; Javier Pedraz, Dermatology Department, Hospital Cl ınico San Carlos, Madrid, Spain; Luc ıa Campos, Dermatology Department, Hospital Cl ınico San Carlos, Madrid, Spain Background: Pityriasis rubra pilaris (PRP) is a rare inflammatory skin disease characterized by reddish orange diffuse scaling, keratotic follicular papules and palmoplantar keratoderma. Case report: A 31-year-old man was referred to our department with a 2-month history of gradually spreading lesions; intense pruritus was also related by the patient. On physical examination, erythematous scaly lesions in a tiny orange tone were observed on his face, trunk and palms, with areas of uninvolved skin mainly in the center of chest and back. A skin biopsy was performed, confirming the clinical suspect of pityriasis rubra pilaris. Blood and chest radiographic examinations did not show any alteration, but intradermal tuberculin test was 12 mm. Oral acitretin and topical corticosteroids were established as initial therapy, with clinical worsening after 2 months. Acitretin was discontinued and cyclosporine was chosen as second line treatment; isoniazid was started 1 month earlier. Eight weeks later, the skin had not improved and a rising in serum liver enzymes was observed. The therapy was maintained for 1 month, and the liver enzymes were higher, so systemic drugs were stopped for 2 months. During this period, liver tests almost returned to normal values. Oral rifampin was initiated under strict liver control, and subcutaneous etanercept (50 mg per week) was started after 4 weeks. Two months later, there was a partial clearance of the cutaneous lesions and the pruritus had disappeared, whereas the hepatic enzymes were almost in normal values. After 4 months of therapy, skin was almost clear and liver values were in normal range. At the present time, 1 year after starting etanercept, the dosage has been reduced to 25 mg per week, and the patient remains practically clear without hepatic alterations. Discussion: The treatment of PRP remains challenging because of the variation in the response rate to different drugs. Systemic retinoids, methotrexate, cyclosporine, and other imunosupresants are accepted as current treatments. Antietumor necrosis factor-alfa antibodies (anti-TNF) have been reported as effective in selected PRP patients in case series. We report a refractory case with good response to etanercept, performing a second-line tuberculosis prophylaxis with rifampin. Commercial support: None identified. P6062 Treatment patterns in the first year for biologic-naive psoriasis patients starting on etanercept and adalimumab in a pharmacy benefit manage- ment setting George J. Joseph, PhD, MS, Amgen Inc, Thousand Oaks, CA, United States; David J. Harrison, PhD, Amgen Inc, Thousand Oaks, CA, United States; Jessy Thomas, PharmD, Amgen Inc, Thousand Oaks, CA, United States; Steven W. Blume, MS, United Biosource Corporation, Bethesda, MD, United States Background: Etanercept (ETN) and adalimumab (ADA) are the most commonly used self-injectable TNF-blockers in the treatment of chronic moderate to severe plaque psoriasis (PsO). This study describes real world treatment patterns of medication persistence, restarts, and switches within a US Pharmacy Benefit Management (PBM) population of biologic-na € ıve PsO patients initiating treatment with ETN or ADA. Methods: Retrospective cohort study using medical and pharmacy claims data of Medco PBM commercially insured adults (age 18-64 years) with a PsO diagnosis initiating therapy on ETN or ADA between 1/18/2008e12/31/2009. Patients were required to be continuously enrolled for $ 6 months before and $ 12 months after biologic initiation and have no biologic drug use in the 6 months before treatment. Patients with a diagnosis for other conditions treated with TNF-blockers were excluded. The first claim for a TNF-blocker was their index claim and also defined their index agent. Treatment patterns over the next 365 days were evaluated. A patient could either remain on their index TNF-blocker during this time or ‘‘switch’’ to another biologic therapy. Patients having a prescription for their index TNF- blocker or another biologic at the end of their 1-year follow up period (last 45 days) were classified as ‘‘persistent on biologic.’’ Patients who stayed on their index TNF- blocker were classified as ‘‘continuous users’’ (no gaps in supply of $ 45 days) or ‘‘intermittent users’’ (if they had gaps). Results: A total of 351 patients initiated ETN and 253 ADA. Demographics were similar in both groups. Half of the patients in both groups were still on their index biologic at end of the year (55% for ETN, 56% for ADA). Relatively few, 13% of ETN and 8% of ADA patients switched from their index TNF-blocker (P ¼.07) during the first year. Females were more likely to switch from either drug than males (19% vs 8%, P \.001). Among patients who persisted on their index TNF-blocker without switching, more ADA patients (72%) had continuous use compared to ETN (55%). ETN had more intermittent users (45% vs 28% of ADA [P ¼.001]). Conclusion: Among biologic naive PsO patients who started on ETN and ADA, there were no significant differences in the rates of switching to another PsO biologic in the first year of therapy. Among patients who persisted on their index TNF-blocker without switching, intermittent use was common and there was more intermittent use of ETN than ADA. Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc, and by Wyeth, which was acquired by Pfizer Inc in October 2009. AB216 JAM ACAD DERMATOL APRIL 2013
Transcript of Treatment of pityriasis rubra pilaris with ustekinumab
P6429Tolerability of ustekinumab in psoriasis of moderate to high degreeassociated to Berger disease
Rosalba Buquicchio, Bari, Italy; Antonio Carpentieri, Taranto, Italy; FrancescoLoconsole, Bari, Italy; Piergiorgio Malagoli, Milan, Italy
We here relate our clinical experience using a biologic therapy with ‘‘monoclonalantibodies directed against interleukin’’ on 3 patients affected by severe psoriasis,complicated by Berger disease. We observed 3 male patients, aged 35 to 50, affectedby moderate to severe psoriasis. All 3 patients could not be treated with traditionalsystemic therapies becuase they were also affected by Berger disease. The diagnosisof Berger disease was confirmed by renal biopsy and histologic examination, thatrevealed the presence of IgA deposits mainly in the renal glomerulus. Afterascertaining the suitability of the 3 patients for biologic therapy through screenings,we performed a nephrologic consultation, evaluating the dosages of proetinuriawithin the 24 hours, creatinuria and creatine clearance. In all 3 patients, pretreat-ment laboratory examinations revealed the presence of proteins in the urine andslightly higher levels of creatininemia. After 3 months from the beginning of thetreatment, we repeated a dosage of the same parameters, observing the persistencyof proteinuria with values not exceeding the previous ones, while the values ofcreatininemia and creatine clearance overlapped with the previous ones. We alsoobserved a significant improvement of psoriasis lesions. Clinically, we recorded thereaching of PASI 75 after 12 weeks of treatment. Throughout the therapy, werecorded no adverse reactions in the 3 patients, nor a worsening in renal function.An interesting outcome was the disappearance of proteinuria after 3 months oftreatment in 1 of the 3 patients, with a persistence of such an outcome in thesubsequent check-ups within 6 and 12 months. The drug proved effective and waswell tolerated by all 3 patients. It did not cause aworsening in the basic comorbidity,in fact, quite the contrary: in 1 case we observed the normalization of a renalfunction parameter. Presently, the 3 patients are still responding to the therapy withPASI 75 and are under scrutiny for renal function with check-ups every 3 months.
AB216
cial support: None identified.
CommerP6043Treatment of pityriasis rubra pilaris with ustekinumab
Sara Fitz, MD, University of Wisconsin, Department of Dermatology, Madison,WI, United States; B. Jack Longley, MD, University of Wisconsin, Department ofDermatology, Madison, WI, United States; David Puchalsky, University ofWisconsin, Department of Dermatology, Madison, WI, United States
Pityriasis rubra pilaris (PRP) is a papulosquamous disease that is characterized byfollicular hyperkeratotic papules which coalesce into plaques with an orange hueand distinctive ‘‘islands of sparing.’’ First-line therapies are often oral retinoids and/ormethotrexate. Case reports and case series have reported successwith azathioprine,cyclosporine, and tumor necrosis factor alpha inhibitors. Our patient, a 47-year-oldman with a 10-year history of PRP, presented after failing to achieve a satisfactoryresponse to many treatments, including topical steroids, acitretin, methotrexate,adalimumab, cyclosporine, and narrowband ultraviolet light therapy. The patientwas started on ustekinumab, an IL-12/23 inhibitor approved for psoriasis, andshowed substantial improvement within four weeks of initiation. He has beenmaintained on this with satisfactory treatment for the past year. This case reportssuggests, as do several others now in the literature, that treatment with ustekinumabshould be considered as a treatment option in patients with PRP.
cial support: None identified.
CommerJ AM ACAD DERMATOL
P7008Treatment of refractory pityriasis rubra pilaris with etanercept
Alberto Conde-Taboada, Dermatology Department. Hospital Cl�ınico San Carlos,Madrid, Spain; Alejandro Fueyo, Dermatology Department, Hospital Cl�ınico SanCarlos, Madrid, Spain; Eduardo L�opez-Bran, Dermatology Department, HospitalCl�ınico San Carlos, Madrid, Spain; Javier Pedraz, Dermatology Department,Hospital Cl�ınico San Carlos, Madrid, Spain; Luc�ıa Campos, DermatologyDepartment, Hospital Cl�ınico San Carlos, Madrid, Spain
Background: Pityriasis rubra pilaris (PRP) is a rare inflammatory skin diseasecharacterized by reddish orange diffuse scaling, keratotic follicular papules andpalmoplantar keratoderma.
Case report: A 31-year-old man was referred to our department with a 2-monthhistory of gradually spreading lesions; intense pruritus was also related by thepatient. On physical examination, erythematous scaly lesions in a tiny orange tonewere observed on his face, trunk and palms, with areas of uninvolved skin mainly inthe center of chest and back. A skin biopsy was performed, confirming the clinicalsuspect of pityriasis rubra pilaris. Blood and chest radiographic examinations did notshow any alteration, but intradermal tuberculin test was 12 mm. Oral acitretin andtopical corticosteroids were established as initial therapy, with clinical worseningafter 2 months. Acitretin was discontinued and cyclosporine was chosen as secondline treatment; isoniazid was started 1 month earlier. Eight weeks later, the skin hadnot improved and a rising in serum liver enzymes was observed. The therapy wasmaintained for 1 month, and the liver enzymes were higher, so systemic drugs werestopped for 2 months. During this period, liver tests almost returned to normalvalues. Oral rifampin was initiated under strict liver control, and subcutaneousetanercept (50mg per week) was started after 4 weeks. Twomonths later, there wasa partial clearance of the cutaneous lesions and the pruritus had disappeared,whereas the hepatic enzymes were almost in normal values. After 4 months oftherapy, skin was almost clear and liver values were in normal range. At the presenttime, 1 year after starting etanercept, the dosage has been reduced to 25 mg perweek, and the patient remains practically clear without hepatic alterations.
Discussion: The treatment of PRP remains challenging because of the variation inthe response rate to different drugs. Systemic retinoids, methotrexate, cyclosporine,and other imunosupresants are accepted as current treatments. Antietumornecrosis factor-alfa antibodies (anti-TNF) have been reported as effective in selectedPRP patients in case series. We report a refractory case with good response toetanercept, performing a second-line tuberculosis prophylaxis with rifampin.
cial support: None identified.
CommerP6062Treatment patterns in the first year for biologic-naive psoriasis patientsstarting on etanercept and adalimumab in a pharmacy benefit manage-ment setting
George J. Joseph, PhD, MS, Amgen Inc, Thousand Oaks, CA, United States; DavidJ. Harrison, PhD, Amgen Inc, Thousand Oaks, CA, United States; Jessy Thomas,PharmD, Amgen Inc, Thousand Oaks, CA, United States; Steven W. Blume, MS,United Biosource Corporation, Bethesda, MD, United States
Background: Etanercept (ETN) and adalimumab (ADA) are the most commonly usedself-injectable TNF-blockers in the treatment of chronic moderate to severe plaquepsoriasis (PsO). This study describes real world treatment patterns of medicationpersistence, restarts, and switches within a US Pharmacy Benefit Management(PBM) population of biologic-na€ıve PsO patients initiating treatment with ETN orADA.
Methods: Retrospective cohort study using medical and pharmacy claims data ofMedco PBM commercially insured adults (age 18-64 years) with a PsO diagnosisinitiating therapy on ETN or ADA between 1/18/2008e12/31/2009. Patients wererequired to be continuously enrolled for $ 6 months before and $ 12 months afterbiologic initiation and have no biologic drug use in the 6 months before treatment.Patients with a diagnosis for other conditions treated with TNF-blockers wereexcluded. The first claim for a TNF-blocker was their index claim and also definedtheir index agent. Treatment patterns over the next 365 days were evaluated. Apatient could either remain on their index TNF-blocker during this time or ‘‘switch’’to another biologic therapy. Patients having a prescription for their index TNF-blocker or another biologic at the end of their 1-year follow up period (last 45 days)were classified as ‘‘persistent on biologic.’’ Patients who stayed on their index TNF-blocker were classified as ‘‘continuous users’’ (no gaps in supply of $ 45 days) or‘‘intermittent users’’ (if they had gaps).
Results: A total of 351 patients initiated ETN and 253 ADA. Demographics weresimilar in both groups. Half of the patients in both groups were still on their indexbiologic at end of the year (55% for ETN, 56% for ADA). Relatively few, 13% of ETNand 8% of ADA patients switched from their index TNF-blocker (P ¼.07) during thefirst year. Females were more likely to switch from either drug than males (19% vs8%, P\.001). Among patients who persisted on their index TNF-blocker withoutswitching, more ADA patients (72%) had continuous use compared to ETN (55%).ETN had more intermittent users (45% vs 28% of ADA [P ¼ .001]).
Conclusion: Among biologic naive PsO patients who started on ETN and ADA, therewere no significant differences in the rates of switching to another PsO biologic inthe first year of therapy. Among patients who persisted on their index TNF-blockerwithout switching, intermittent use was common and there was more intermittentuse of ETN than ADA.
funded by Immunex Corporation, a wholly owned subsidiary oby Wyeth, which was acquired by Pfizer Inc in October 2009.
Research f AmgenInc, and
APRIL 2013
