Article
Secukinumab Significantly Improves Physical Function, Quality of Life, and Work Productivity through 52 Weeks in Subjects with Active Ankylosing Spondylitis in the Phase 3 MEASURE 2 Study
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Authors
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Joachim Sieper
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Atul Deodhar
- Oregon Health & Science University, Arthritis & Rheumatic Diseases, Portland, United States of America
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Paul Emery
- Johns Hopkins University, Baltimore, United States
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Brian Porter
- Novartis Pharmaceuticals Corporation, NJ, USA, New Jersey, USA
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Mats Andersson
- Novartis Pharma AG, Basel, Switzerland
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Hanno B. Richards
- Novartis Pharma AG, Basel, Switzerland
| Published: | September 1, 2015 |
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Outline
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Introduction: Interleukin (IL)-17A is implicated in the pathogenesis of ankylosing spondylitis (AS) [1]. Inhibition of this cytokine with secukinumab, a human anti–IL-17A monoclonal antibody, has demonstrated rapid reduction in the signs and symptoms of AS at Week (Wk) 16 in a phase 3 trial (MEASURE 2; NCT01649375) [2].
The objective is to evaluate the impact of subcutaneous (s.c.) secukinumab on patient-reported outcomes (PROs) at 16 and 52 wks in the randomized, double-blind, placebo-controlled MEASURE 2 study.
Methods: 219 adults with active AS, despite adequate therapy with nonsteroidal anti-inflammatory drugs, were randomized to receive s.c. secukinumab 150 mg, 75 mg, or placebo (PBO) at baseline, Wk 1, 2, and 3, and every 4 wks starting at Wk 4. At Wk 16, subjects randomized to PBO at baseline were re-randomized to receive secukinumab 150 mg or 75 mg every 4 wks. PROs were measured every 4 wks using the following questionnaires: short form 36 (SF-36), EuroQoL (EQ-5D), AS Quality of Life (ASQoL), Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) and Work Productivity and Activity Impairment – General Health (WPAI-GH). SF-36 physical component summary (SF-36 PCS) and ASQoL assessed at Wk16 were predefined secondary endpoints. Other endpoints were exploratory.
Results: Demographics and disease severity were balanced across groups at baseline with subjects experiencing moderate to severe levels of fatigue and impaired health-related QoL. At Wk 16, secukinumab 150 mg significantly improved SF-36 PCS and ASQoL scores vs PBO; improvements in these parameters were observed already from Wk 4. Improvements vs PBO were also noted in FACIT-Fatigue at Wk 16. Mean changes from baseline with secukinumab at Wk 16 were greater than the minimum clinically important difference (MCID) for SF-36 PCS, ASQoL and FACIT-Fatigue. Reductions in WPAI-GH were also observed with secukinumab vs PBO at Wk 16. Improvements in PROs from baseline were sustained or increased through Wk 52.
Conclusion: In subjects with active AS, secukinumab 150 mg provided rapid and sustained improvements in PROs and illness-associated reductions in work productivity.
