Journal of Clinical and Aesthetic Dermatology

MauiDerm Abstract Supplement 2016

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

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[ 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 S17 S ecukinumab Exhibits Low Immunogenicity During 104 Weeks of Treatment in Subjects with Moderate-to-Severe Plaque Psoriasis P resenters: 1 R eich K; 2 A Blauvelt A; 3 Warren RB; 4 Szepietowski JC; 5 Sigurgeirsson B; 6 Langley RGB; 7 Tyring S; 8 Messina I; 8 Fox T; 8 Papavassilis C; 8 Bruin G A ffiliations: 1 D ermatologikum Hamburg and Georg-August-University Göttingen, Hamburg, Germany; 2 Oregon Medical Research Center, Portland, OR; 3 The Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester, UK; 4 Wroclaw Medical University, Wroclaw, Poland; 5 Hudlæknastöðin Smaratorg 1 201 Kópavogur, Iceland; 6 Dalhousie University, Halifax, Nova Scotia, Canada; 7 University of Texas Health Science Center & Center for Clinical Studies, Houston, TX; 8 Novartis Pharma AG, Basel, Switzerland. Introduction and Objectives: Secukinumab, a human monoclonal antibody (mAb) that selectively targets interleukin (IL)-17A, is highly efficacious in the treatment of moderate-to-severe psoriasis, starting at early time points, with a sustained effect and a favorable safety profile. Biologic drugs can induce anti-drug antibodies (ADA) that may affect pharmacokinetics, diminish response, or cause hypersensitivity. This trial is a 4-year extension of two 1-year secukinumab Phase 3 studies in moderate-to-severe psoriasis, ERASURE and FIXTURE. Here, we evaluated the immunogenicity of secukinumab at Week 104 of treatment in this extension study. Methods: Subjects completing either core study with at least a partial response (Psoriasis Area and Severity Index [PASI] ≥50) to secukinumab at Week 52 were eligible for inclusion. PASI 75 responders in each secukinumab dose group of the core studies were randomized 2:1 to continue the same doses of secukinumab (300mg or 150mg) or receive placebo (300mg placebo or 150mg placebo) every four weeks. Subjects who relapsed in the two p lacebo arms were retreated with secukinumab. Partial responders (PASI ≥50 but <75) from the core studies continued the same secukinumab doses. Blood samples o btained at Week 52, Week 76, and Week 104 were assayed for ADA. Presence of treatment-emergent ADA (TE-ADA) was defined as a positive ADA signal detected in post- t reatment samples from subjects with a negative signal at baseline in the core studies. Confirmed TE-ADA samples were analyzed for neutralizing potential Results: TE-ADA were detected in 6/1,142 (0.53%) subjects tested; one in the 300mg arm, three in the 150mg arm (one partial responder), and two in the 150mg placebo arm (one relapsed and regained response following retreatment). Two subjects, one each in the 300mg and 150mg placebo treatment groups, tested positive for neutralizing antibodies at Week 76. Among the six subjects with TE-ADA, four later reverted to a seronegative state during therapy. TE- ADA, including in the two subjects with neutralizing antibodies, were not associated with loss of response or hypersensitivity reactions, and pharmacokinetics (PK) were normal in subjects for whom data were available and assessable (3/6). In terms of overall efficacy, secukinumab 300mg was consistently more efficacious than 150mg, with strong sustained efficacy to Week 104. Immunogenicity findings were consistent with the overall Phase 3 psoriasis program, which had a TE- ADA incidence of 0.4%. Conclusion: TE-ADA and neutralizing antibodies were reported rarely with secukinumab treatment out to two years (104 weeks) and were not associated with loss of secukinumab efficacy or other issues of clinical concern. Financial disclosures/funding: This research was funded by Novartis Pharma AG, Basel, Switzerland. Secukinumab Delivers Greater Improvement in Health-Related Quality of Life Compared to Ustekinumab in Subjects With Moderate-to-Severe Plaque P soriasis: 16-Week Data From the CLEAR Study Presenters: 1 Thaci D; 2 Blauvelt A; 3 Reich K; 4 Tsai TF; 5 Vanaclocha F; 6 Kingo K; 7 Ziv MI; 8 Pinter A; 9 Hugot S; 1 0 Y ou R; 1 1 A ugustin M; 9 M ilutinovic M Affiliations: 1 Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lü beck, Germany; 2 Oregon Medical R esearch Center, Portland, OR; 3 Dermatologikum Hamburg and Georg- August-University Göttingen, Göttingen, Germany; 4 Deparment of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan; 5 Servicio de Dermatología, Hospital 12 de Octubre, Madrid, Spain; 6 Department of Dermatology and Venereology, Tartu University, Tartu, Estonia; 7 Dermatology Department, Ha'Emek Medical Center, Afula, Israel; 8 Klinik fü r Dermatologie, Venerologie und Allergologie, Universitätsklinikum Frankfurt, Frankfurt, Germany; 9 Novartis Pharma AG, Basel, Switzerland; 1 0 Novartis Beijing Novartis Pharma Co. Ltd, Shanghai, China; 11 University Medical Center, Hamburg, Germany. Introduction and Objectives: Secukinumab, a human anti– interleukin (IL)-17A monoclonal antibody (mAb), has been previously reported to be superior to etanercept in achieving strong responses with a favorable safety profile in moderate-to- severe plaque psoriasis. In the ongoing CLEAR study, which is a multicenter, double-blind, parallel-group, active comparator-controlled Phase 3b study comparing efficacy/safety of secukinumab versus ustekinumab (an anti-IL-12/23 mAb) in adults with moderate-to-severe plaque psoriasis, superior efficacy was reported for secukinumab versus ustekinumab, with a superior Psoriasis Area and Severity Index (PASI) 90 response in the secukinumab arm at Week (Wk) 16. Here, we report the 16-week Patient Reported Outcomes (PROs) from the CLEAR study. Methods: Subjects were randomized 1:1 to receive subcutaneous injection of S 1 7

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