Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT

Springer Science and Business Media LLC - Tập 23 Số 1 - 2021
Jürgen Braun1, Ricardo Blanco2, Helena Marzo‐Ortega3, Lianne S. Gensler4, Filip Van den Bosch5, Stephen Hall6, Hideto Kameda7, Denis Poddubnyy8, Marleen van de Sande9,10, Anna Wiksten11, Brian Porter12, Abhijit Shete11, Hanno B. Richards11, Sibylle Haemmerle11, Atul Deodhar13
1Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany
2IDIVAL, Hospital University Marqués de Valdecilla, Santander, Spain
3NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and LIRMM, University of Leeds, Leeds, UK
4Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, USA
5Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium
6Monash University, Melbourne, Australia
7Toho University, Tokyo, Japan
8Charité, Universitätsmedizin, Berlin, Germany
9Amsterdam Rheumatology and Immunology Centre (ARC), Amsterdam, The Netherlands
10Department of Rheumatology and Clinical Immunology, Amsterdam Infection & Immunity Institute, Amsterdam UMC, AMC/University of Amsterdam, Amsterdam, The Netherlands
11Novartis Pharma AG, Basel, Switzerland
12Novartis Pharmaceuticals Corporation, East Hanover, USA
13Oregon Health & Science University, Portland, USA

Tóm tắt

Abstract Background To investigate the efficacy of secukinumab in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) grouped by disease activity as assessed by C-reactive protein (CRP) levels and/or magnetic resonance imaging (MRI) scores, human leukocyte antigen (HLA)-B27 status, and sex. Methods The phase III PREVENT study randomized (1:1:1) 555 patients to receive subcutaneous secukinumab 150 mg with (LD) or without (NL) loading dose or placebo weekly, followed by every 4 weeks starting at week 4. Here, we report the results of a post hoc analysis reporting the efficacy outcomes (pooled secukinumab) to 16 weeks by CRP, MRI, HLA-B27, and sex. Results Efficacy differences between the secukinumab and the placebo groups were highest in the CRP+, MRI+, HLA-B27+, and male subgroups, particularly for Ankylosing Spondylitis Disease Activity Score-CRP inactive disease and Assessment of SpondyloArthritis international Society (ASAS) partial remission outcomes. ASAS40 response rates in the CRP+/MRI+ subgroup was 52.3% (secukinumab) versus 21.8% (placebo; P < 0.0001) at week 16. ASAS40 response rates (secukinumab versus placebo) were 43.9% versus 32.6% in HLA-B27+, 32.7% versus 16.4% in HLA-B27− subgroups, 51.2% versus 30.8% in male, and 31.7% versus 25.3% in female patients, respectively. Conclusions Secukinumab improved the signs and symptoms of nr-axSpA across patients grouped by CRP (+/−) and/or MRI (+/−) status, HLA-B27 (+/−) status, and sex. The highest treatment differences between secukinumab and placebo were observed in patients with both elevated CRP and evidence of sacroiliitis on MRI. Treatment difference was minimal between HLA-B27 (+) and (−) subgroups. Male patients had higher relative responses than female patients. Trial registration ClinicalTrials.gov, NCT02696031. Registered on 02 March 2016

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