Abstract Number: 133

Secukinumab demonstrates an acceptable safety proftle in moderate to severe plaque psoriasis: Pooled analysis of 10 phase 2/3 studies

P. Foley, C. Griffiths, K. Reich, C.L. Leonardi, A. Blauvelt5, N.N. Mehta, T.F. Tsai, Y. Gong, C. Papavassilis, J. Huang8, T. Fox, P. van de Kerkhof

Meeting: 2016 Dermcoll

Session Information

Date: -

Session Title: Poster Presentations

Session Time: -

Introduction: Secukinumab, a fully human anti–IL-17A monoclonal antibody, has shown efficacy in psoriasis. We conducted a pooled safety analysis of 3993 psoriasis sub- jects from 10 phase 2/3 secukinumab studies.

Methods: Subjects received s.c. secukinumab 300 mg, 150 mg, placebo (PBO), or etanercept 50 mg (one study). Adverse events (AEs), and AEs of Interest (infections, can- didiasis, neutropenia, Crohn’s disease [CD], ulcerative coli- tis, [UC], malignancy, major adverse cardiovascular events [MACE]) were analysed at Week 12 and Week 52.

Results: AEs with secukinumab 300 mg (54.2%) and 150 mg (56.3%) at Week 12 were numerically higher vs. PBO (50.4%) and comparable to etanercept (57.6%). At Week 52, exposure-adjusted incidence rates (IR per 100 subject-years) of AEs with secukinumab 300 mg (236.1; n = 1410) and 150 mg (239.9; n = 1395) were lower vs. PBO (351.8; n = 793) and comparable to etanercept (243.4; n = 323). IR of infections showed a similar trend, while serious AEs and serious infections were comparable across all treatments. The IR of non-serious, mild/moderate, localized skin/mucosal candidiasis was higher with secuk- inumab 300 mg. There was one death (hemorrhagic stroke [150 mg]), unrelated to treatment as judged by the investi- gator. Neutropenia was infrequent (Grade 3, n = 18 for any secukinumab dose; no Grade 4 cases), transient, not asso- ciated with serious infections and did not lead to discontin- uations. No clinically meaningful difference was found in IRs of MACE, CD, UC and malignancy.

Conclusions: This analysis of pooled safety data from 10 studies supports a favourable safety profile of secukinumab over 52 weeks in subjects with psoriasis, although more data are needed to make definitive conclusions for MACE, CD, UC and malignancy.