Artikel
Secukinumab improves multiple parameters of disease activity in subjects with active ankylosing spondylitis through 52 weeks of subcutaneous therapy: data from the phase 3 MEASURE 2 study
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Autoren
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Jürgen Braun
- Rheumazentrum Ruhrgebiet, Herne
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Joachim Sieper
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Jacob A. Aelion
- West Tennessee Research Institute, Jackson, TN, USA, Jackson, USA
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Paul Emery
- Johns Hopkins University, Baltimore, United States
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Atul Deodhar
- Oregon Health & Science University, Arthritis & Rheumatic Diseases, Portland, United States of America
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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
| Veröffentlicht: | 1. September 2015 |
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Gliederung
Text
Introduction: Disease activity in ankylosing spondylitis (AS) encompasses a wide range of clinical manifestations. As such, a number of composite and single component activity measures exist.
The objective is to describe the effect of subcutaneous (s.c) treatment with secukinumab on multiple parameters of disease activity at Wks 16 and 52 in subjects enrolled in the randomized, double-blind, placebo-controlled phase 3 MEASURE 2 study (NCT01649375).
Methods: 219 adults with active AS were randomized to receive s.c. secukinumab 75 mg, 150 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 were re-randomized to receive seckinumab 150 mg or 75 mg every 4 wks. Disease activity parameters included Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-reactive protein (ASDAS-CRP), ASDAS-erythrocyte sedimentation rate (ASDAS-ESR), and the proportion of subjects achieving ≥50% improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score (BASDAI50).
Results: 84.7% and 82.2% of subjects in the secukinumab 150 and 75 mg arms, respectively, completed 52 wks of treatment. Secukinumab 150 mg s.c. was consistently associated with improvements vs PBO across multiple measures of disease activity. Improvements in the secukinumab 150 mg s.c. arm were consistently greater than with 75 mg. At Wk 16, a higher proportion of subjects receiving secukinumab 150 mg (47.2%) and 75 mg (38.4%) achieved a clinically important change compared with PBO (18.9%) in ASDAS-CRP. Similarly, more subjects receiving secukinumab 150 mg (48.6%) and 75mg (42.5%) achieved a clinically important change compared with PBO (20.3%) in ASDAS-ESR at Wk 16. Major improvement in ASDAS-CRP at Wk 16 was achieved in 25.0%, 15.1% and 4.1% in the secukinumab 150 mg, 75 mg and PBO arms, respectively; equivalent rates for ASDAS-ESR were 27.8%, 17.8% and 8.1% (P < 0.05 for all comparisons vs PBO). Improvements with secukinumab were sustained through 52 wks.
Conclusion: Secukinumab reduced disease activity in subjects with active AS, with approximately 50% of subjects who received the 150mg dose achieving a clinically important change in ASDAS-CRP and ASDAS-ESR at Wk 16. These improvements were sustained through Wk 52.
