Article
Intravenous Loading and Subcutaneous Maintenance with Secukinumab Provides Sustained Improvement in Multiple Measures of Disease Activity in Subjects with Active Ankylosing Spondylitis: 52-week Data from the Phase 3 MEASURE 1 study
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Authors
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Jürgen Braun
- Rheumazentrum Ruhrgebiet, Herne
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C. Wei
- Chung Shan Medical University Hospital, Taichung, Taiwan, Taichung, Taiwan, China
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Dominique Baeten
- Academic Medical Center/University of Amsterdam, Clinical Immunology and Rheumatology, Amsterdam, The Netherlands
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Piet Geusens
- Maastricht University Hospital, Maastricht, Maastricht, Netherlands
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Brian Porter
- Novartis Pharmaceuticals Corporation, NJ, USA, New Jersey, USA
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Ruvie Martin
- Novartis Pharmaceuticals Corporation, NJ, USA, New Jersey, USA
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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: Multiple methods of assessing disease activity in ankylosing spondylitis (AS) exist. We report the effect of secukinumab, a human anti–interleukin-17A monoclonal antibody, on disease activity in the phase 3 study, MEASURE 1 (NCT01358175).
The objective is to evaluate the short- and long-term efficacy of intravenous (i.v.) loading and subcutaneous (s.c.) maintenance dosing of secukinumab on multiple disease activity endpoints.
Methods: 371 adults with active AS were randomized to receive i.v. secukinumab 10 mg/kg (Week [Wk] 0, 2, 4) followed by s.c. secukinumab 75 mg, or by s.c. secukinumab 150 mg every 4 weeks, or placebo (PBO). PBO subjects were re-randomized to secukinumab 75 mg or 150 mg s.c. based on Assessment of Spondyloarthritis International Society (ASAS) 20 response at Wk 16, with non-responders switched at Wk 16 and responders at Wk 24. Measures of disease activity included Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-reactive protein (ASDAS-CRP), ASDAS-erythrocyte sedimentation rate (ASDAS-ESR), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). In addition, the effects of secukinumab on individual components of the ASAS response criteria are reported.
Results: 84.8% and 89.5% of subjects in the secukinumab 150 mg and 75 mg arms, respectively, completed 52 wks of treatment. Secukinumab improved ASDAS-CRP, ASDAS-ESR, patient assessments of disease activity and pain, Bath Ankylosing Spondylitis Functional Index (BASFI) and BASDAI at Wk 16 vs PBO. At Wk 16 a higher proportion of subjects receiving secukinumab 150 mg (58.4%) and 75 mg (50.0%) achieved a clinically important change compared with PBO (16.4%) in ASDAS-CRP. Similarly, a higher proportion of subjects receiving secukinumab 150 mg (56.0%) and 75 mg (51.6%) achieved a clinically important change compared with PBO (14.8%) in ASDAS-ESR at Wk 16. Between 24% and 31% of secukinumab-treated subjects in either treatment arm achieved a major improvement in ASDAS-CRP or ASDAS-ESR at Wk 16 compared with 2% in the PBO arm. Improvements with secukinumab were sustained through 52 wks.
Conclusion: Secukinumab rapidly reduces disease activity in subjects with active AS, with at least 50% of subjects achieving a clinically important change in ASDAS-CRP and ASDAS-ESR at Wk 16. Improvements were sustained over 52 wks.
