Journal of Clinical and Aesthetic Dermatology

MauiDerm Abstract Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

Issue link:

Contents of this Issue


Page 22 of 27

[ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y S19 S 1 9 n ovel, fully human monoclonal antibody indicated for the treatment of moderate-to-severe plaque psoriasis and has been available to US patients since March of 2015. According to the U S product label, the recommended dose is 300mg. For some patients, a dose of 150mg may be acceptable. Methods: Secukinumab Service Request Forms (SRFs) jointly filled by p hysicians and patients for initial secukinumab prescription from March 1, 2015, to May 31, 2015, were analyzed. All patients provided written informed consent. Information on the prescribed secukinumab dose and patient characteristics was analyzed descriptively. Results: The analysis included 5,050 secukinumab SRFs completed by 1,989 unique physicians. Patients were from all regions of the United States: Northeast (14.5%), Midwest (20.2%), South (45.6%), and West (19.7%). The patient sample was roughly balanced by sex (females, 45.7%; males, 53.8%; missing data, 0.5%) and distributed across a wide range of age groups: 18–24 years (2.6%), 25–34 (10.6%), 35–44 (20.4%), 45–54 (25.1%), 55–64 (25.2%), 65+ (16.2%). 2,494 patients (49.4%) had previously used a biologic (missing or unknown for rest of data), with 60 percent (1,486) using two or more biologics. Overall, the initial secukinumab dose was 300mg for 99.9 percent of the patients (5,046) and 150mg for only four patients (0.1%). A majority of the SRFs requested the autoinjector pen as the injection device (4,543; 90.0%) rather than the pre-filled syringe (507; 10.0%). Conclusion: Using a large number of secukinumab SRFs filled by US patients and their physicians distributed from all regions, this analysis found that secukinumab is predominantly prescribed at the recommended 300mg dose. Therefore, secukinumab is being prescribed in accordance with the product label. Financial disclosures/funding: This study was funded by Novartis Pharmaceuticals Corporation. Pregnancy Outcomes in the Tofacitinib Psoriasis Safety Database up to April 2014 P resenters: 1 S teven Feldman; 2 Alexandra B. Kimball; 3 Richard B. Warren; 4 Don Frazier; 4 James Proulx; 5 Amy Marren Affiliations: 1 Department of D ermatology, Wake Forest University School of Medicine, Winston Salem, NC; 2 Department of Dermatology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; 3 U niversity of Manchester, Manchester, UK; 4 Pfizer Inc, Groton, CT; 5 Pfizer Inc, Collegeville, PA Introduction: Tofacitinib is an oral Janus kinase inhibitor that is being investigated for psoriasis. No adverse fetal effects were observed in preclinical studies with exposures corresponding to the human dose tofacitinib 10mg twice daily; at approximately >10 and 100-fold this exposure, tofacitinib was teratogenic (visceral and skeletal abnormalities) in rabbits and rats, and decreased the number of viable pups in rats. There are no well-controlled tofacitinib studies in pregnant women; the psoriasis clinical development program excluded pregnant patients and required contraception use. If a patient became pregnant, treatment discontinuation was mandatory. Pregnancies were followed up to investigate occurrence of any adverse outcomes. Objective: To understand potential effects of tofacitinib on pregnancy outcomes in patients with psoriasis. Methods: Cases were identified from Pfizer's internal safety database, including all tofacitinib exposure in clinical studies through April 2014. Cases included females administered study medication at time of conception and/or fetuses exposed to study medication through maternal or paternal exposure. Pregnancy outcomes were categorized as healthy newborns, spontaneous abortion, medical termination, pending, or lost to follow-up. Results: In total 16 female patients, aged 19 to 40 years, became pregnant while on study drug over the course of 5,203.6 patient-years of tofacitinib exposure. Most patients were treated with tofacitinib at the time of conception and early gestation. There w ere no cases of fetal demise or birth defects reported among these 16 patients; four abortions (1 spontaneous, 3 elective) were reported. All other patients had h ealthy newborns (6), had not yet reported pregnancy outcome (5), or were lost to follow-up (1). There were 42 cases of paternal exposure to tofacitinib: 13 healthy newborns, 5 s pontaneous abortions, 19 pending outcome, and 5 lost to follow-up. Conclusion: No pregnancies resulting in birth defects or fetal demise were reported among cases of maternal tofacitinib exposure. Pregnancy outcomes reported here were generally similar to those reported with biologic psoriasis therapies, and in tofacitinib-treated patients with rheumatoid arthritis. PSORIATIC ARTHRITIS Secukinumab Safety and Tolerability in Patients with Active Psoriatic Arthritis and Psoriasis: Results from a Pooled Safety Analysis Presenters: 1 Mease P; 2 McInnes IB; 3 Gottlieb AB; 4 Widmer A; 5 Pricop L; 4 Mpofu S Affiliations: 1 Swedish Medical Center and University of Washington, Seattle, WA; 2 University of Glasgow, Glasgow, UK; 3 Tufts Medical Center, Boston, MA; 4 Novartis Pharma AG, Basel, Switzerland; 5 Novartis Pharmaceuticals Corporation, East Hanover, NJ Introduction and Objectives: Secukinumab, a human anti– interleukin (IL)-17A monoclonal antibody (mAb), has been shown to improve the signs and symptoms of psoriasis (PSO) and psoriatic arthritis (PsA). Here, we describe the safety profile of secukinumab from a large cohort of patients with PSO and patients with PsA, using pooled data from Phase 3 studies. Methods: Safety data were pooled from five double-blind, randomized, placebo-controlled Phase 3 studies in patients with PSO (ERASURE [NCT01365455], FIXTURE [NCT01358578], SCULPTURE [NCT01406938], FEATURE

Articles in this issue

Archives of this issue

view archives of Journal of Clinical and Aesthetic Dermatology - MauiDerm Abstract Supplement 2016