gms | German Medical Science

43. Kongress der Deutschen Gesellschaft für Rheumatologie, 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 25. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

02.-05. September 2015, Bremen

Secukinumab Safety and Tolerability in Patients With Active Psoriatic Arthritis: Pooled Safety Analysis of Two Phase 3, Randomized, Controlled Trials (FUTURE 1 and FUTURE 2)

Meeting Abstract

  • Hendrik Schulze-Koops - Klinikum der Universität München, Medizinische Klinik und Poliklinik IV, Rheumaeinheit, München
  • Philip Mease - Swedish Medical Center and University of Washington, Seattle, United States of America
  • Iain McInnes - University of Glasgow, Glasgow, England
  • Hanno B. Richards - Novartis Pharma AG, Basel, Switzerland
  • Luminita Pricop - Novartis Pharmaceuticals Corporation, New Jersey, USA
  • Albert Widmer - Novartis Pharma AG, Basel, Switzerland
  • Shepard Mpofu - Novartis Pharma AG, Basel, Switzerland

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Bremen, 02.-05.09.2015. Düsseldorf: German Medical Science GMS Publishing House; 2015. DocSpA.12

doi: 10.3205/15dgrh218, urn:nbn:de:0183-15dgrh2188

Published: September 1, 2015

© 2015 Schulze-Koops et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Introduction: The objective is to describe the safety profile of secukinumab, an anti–interleukin-17A monoclonal antibody, in patients (pts) with psoriatic arthritis (PsA) treated in phase 3 studies.

Methods: Safety data from two randomized, double-blind, placebo (PBO)-controlled, phase 3 studies in pts with active PsA, FUTURE 1 (NCT01392326) and FUTURE 2 (NCT01752634), were pooled. A total of 1003 pts (n = 606 in FUTURE 1 and n = 397 in FUTURE 2) were randomized to secukinumab or PBO. Adverse Events (AE) reported during the study periods included AEs of special interest, such as Candida infections, neutropenia, MACE and malignancy. Anti-drug antibodies (ADAs) were assessed using a Meso Scale Discovery bridging assay with a stepwise approach for screening, confirmation and titration. All randomized pts were included in the pooled safety analysis.

Results: 974 pts received ≥1 dose of secukinumab (955 pt-years of exposure). Baseline demographics, disease/medical history and concomitant medications were similar between the pooled secukinumab and PBO populations. During the PBO-controlled period, AEs)/serious AEs (SAEs) were reported in 58.9%/3.4% and 58.3%/4.0% of pts in the pooled secukinumab and PBO groups, respectively. Exposure-adjusted AE/SAE incidence rates across the entire safety period (mean/max exposure: 358.1/721 days secukinumab; 128.6/233 days PBO) were 210.3/9.0 and 319.6/13.6 per 100 pt-years with secukinumab and PBO, respectively; 25 (2.6%) pts receiving secukinumab discontinued due to AEs during this period vs. 14 (4.7%) with PBO. Nasopharyngitis and upper respiratory tract infection were the most frequent AEs with secukinumab and PBO in both the PBO-controlled period and throughout the entire safety period. There was one death due to intracranial hemorrhage in a pt with a history of CV disease who received secukinumab. The incidence of inflammatory bowel disease (IBD)/Crohn’s, Candida infections, neutropenia, MACE and malignancy was low with secukinumab. Injection site reactions with secukinumab were observed in 26 (2.7%) pts vs. 3 (1.0%) with PBO. Treatment-emergent ADAs were detected in 1 (0.1%) pt, with no associated loss of efficacy.

Conclusion: Secukinumab was well-tolerated in pts with active PsA, with a low incidence of SAEs and discontinuations due to AEs, and a low potential for immunogenicity.