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 Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis: 52 Week Data from MEASURE 2, a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial with Subcutaneous Loading and Maintenance Dosing

Meeting Abstract

  • Joachim Sieper - Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
  • Jürgen Braun - Rheumazentrum Ruhrgebiet, Herne
  • Xenofon Baraliakos - Rheumazentrum Ruhrgebiet, Herne
  • Dominique Baeten - Academic Medical Center/University of Amsterdam, Clinical Immunology and Rheumatology, Amsterdam, The Netherlands
  • Maxime Dougados - Hôpital Cochin, Department of Rheumatology, Paris, France
  • Paul Emery - Johns Hopkins University, Baltimore, United States
  • Atul Deodhar - Oregon Health & Science University, Arthritis & Rheumatic Diseases, Portland, United States of America
  • C. Wei - Chung Shan Medical University Hospital, Taichung, Taiwan, Taichung, Taiwan, China
  • Brian Porter - Novartis Pharmaceuticals Corporation, NJ, USA, New Jersey, USA
  • Mats Andersson - Novartis Pharma AG, Basel, Switzerland
  • Shephard Mpofu - Novartis Pharma AG, Basel, Switzerland
  • Hanno B. Richards - 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.08

doi: 10.3205/15dgrh214, urn:nbn:de:0183-15dgrh2148

Published: September 1, 2015

© 2015 Sieper 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: In MEASURE 2 (NCT01649375), subcutaneous (s.c) administration of secukinumab improved the signs and symptoms of ankylosing spondylitis (AS) through 16 weeks (wks) of therapy [1].

The objective is to investigate the long-term (52 wks) efficacy and safety of s.c secukinumab in in the MEASURE 2 study.

Methods: 219 adults with active AS, despite therapy with nonsteroidal anti-inflammatory drugs, were randomized to receive s.c secukinumab 150mg, 75mg, or placebo (PBO) at baseline, Wk 1, 2, and 3, and every 4 wks starting from Wk 4. At Wk 16, subjects in the PBO group were re-randomized to secukinumab 150mg or 75mg every 4 wks. The primary endpoint was the proportion of subjects achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 response at Wk 16. Secondary endpoints included ASAS40, high sensitivity C-reactive protein (hsCRP), ASAS 5/6, Bath Ankylosing Spondylitis Disease Activity (BASDAI), Short Form-36 Health Survey Physical Component Summary (SF-36 PCS), Ankylosing Spondylitis Quality of Life (ASQoL), and ASAS partial remission.

Results: 181 pts (82.6%) completed 52 wks of treatment. ASAS20 response rate at Wk 16 was 61.1% with secukinumab 150mg vs 28.4% with PBO (P=0.0001). Secukinumab 150mg also significantly improved hsCRP, ASAS40, ASAS 5/6, BASDAI, SF-36 PCS and ASQoL at Wk 16, compared with PBO. Clinical responses with secukinumab. 75mg did not reach statistical significance for any of the pre-specified endpoints. Improvements with secukinumab 150mg were sustained through Wk 52; ASAS20/40 response rates with secukinumab 150mg were 73.8%/57.4% at Wk 52 (observed data). ASAS20/40 response rates in subjects originally randomized to PBO who received secukinumab 150mg (n=34) were 75.0%/56.3% at Wk 52. Exposure-adjusted adverse event (AE) rates were 214.1, 211.7 and 443.2 per 100 patient-years with secukinumab 150mg, 75mg and PBO, respectively. The respective rates of serious AEs were 6.6, 7.7 and 14.0. The most common serious AE (SAE) was serious infections; no subject discontinued therapy due to a SAE.

Conclusion: Secukinumab 150mg s.c provided sustained improvements to 52 weeks in the signs and symptoms of AS, reducing inflammation, and improving physical function and health-related quality of life. Secukinumab was well tolerated; safety findings were consistent with previous reports.


References

1.
Sieper J, et al. Arthritis Rheumatol. 2014;66(11Suppl):S232.