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

Arthritis Research & Therapy

Denis Poddubnyy¹  Filip van den Bosch²  Lianne S. Gensler³  Marleen van de Sande⁴  Ricardo Blanco⁵  Stephen Hall⁶  Helena Marzo-Ortega⁷  Abhijit Shete⁸  Anna S. Wiksten⁸  Sibylle Haemmerle⁸  Hanno B. Richards⁸  Brian O. Porter⁹  Atul Deodhar^1,10  Jürgen Braun^1,11  Hideto Kameda^1,12 

[1] Charité Universitätsmedizin, Berlin, Germany;Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium;Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, USA;Department of Rheumatology and Clinical Immunology, Amsterdam Infection & Immunity Institute, Amsterdam UMC, AMC/University of Amsterdam, Amsterdam, The Netherlands;Amsterdam Rheumatology and Immunology Centre (ARC), Amsterdam, The Netherlands;IDIVAL, Hospital University Marqués de Valdecilla, Santander, Spain;Monash University, Melbourne, Australia;NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and LIRMM, University of Leeds, Leeds, UK;Novartis Pharma AG, Basel, Switzerland;Novartis Pharmaceuticals Corporation, East Hanover, USA;Oregon Health & Science University, Portland, USA;Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany;Toho University, Tokyo, Japan;

关键词: Non-radiographic axial spondyloarthritis;    C-reactive protein;    Magnetic resonance imaging;    Interleukins;    Biologicals;    Human leukocyte antigen B27;    Gender;   

DOI  :  10.1186/s13075-021-02613-9

来源: Springer

【 摘 要 】

BackgroundTo 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.MethodsThe 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.ResultsEfficacy 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.ConclusionsSecukinumab 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 registrationClinicalTrials.gov, NCT02696031. Registered on 02 March 2016

【 授权许可】

CC BY