Journal Article

Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials

Maksymowych, Walter P, Xu, Huji, Marten, Alexander, Oortgiesen, Marga, Ellis, Alicia M, Van den Bosch, Filip, van der Heijde, Désirée, Magrey, Marina, Baraliakos, Xenofon, Dougados, Maxime, Massow, Ute, Haroon, Nigil, Poddubnyy, Denis, Brown, Matthew A, Dobashi, Hiroaki, Gaffney, Karl, Shepherd-Smith, Julie, Elewaut, Dirk, Deodhar, Atul, Fleurinck, Carmen, Gensler, Lianne S, Tomita, Tetsuya, Rudwaleit, Martin, Vaux, Thomas

2023

Overview

ObjectivesAxial spondyloarthritis (axSpA) is a complex disease with diverse manifestations, for which new treatment options are warranted. BE MOBILE 1 (non-radiographic (nr)-axSpA) and BE MOBILE 2 (radiographic axSpA (r-axSpA)) are double-blind, phase 3 trials designed to evaluate efficacy and safety of bimekizumab, a novel dual interleukin (IL)-17A and IL-17F inhibitor, across the axSpA spectrum.MethodsIn parallel 52-week trials, patients with active disease were randomised 1:1 (nr-axSpA) or 2:1 (r-axSpA) to bimekizumab 160 mg every 4 weeks:placebo. From week 16, all patients received bimekizumab 160 mg every 4 weeks. Primary (Assessment of SpondyloArthritis international Society ≥40% improvement (ASAS40)) and secondary endpoints were assessed at week 16. Here, efficacy and treatment-emergent adverse events (TEAEs) are reported up to week 24.Results254 patients with nr-axSpA and 332 with r-axSpA were randomised. At week 16, primary (ASAS40, nr-axSpA: 47.7% bimekizumab vs 21.4% placebo; r-axSpA: 44.8% vs 22.5%; p<0.001) and all ranked secondary endpoints were met in both trials. ASAS40 responses were similar across TNFi-naïve and TNFi-inadequate responder patients. Improvements were observed in Ankylosing Spondylitis Disease Activity Score (ASDAS) states and objective measures of inflammation, including high-sensitivity C-reactive protein (hs-CRP) and MRI of the sacroiliac joints and spine. Most frequent TEAEs with bimekizumab (>3%) included nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis. More fungal infections (all localised) were observed with bimekizumab vs placebo; no major adverse cardiovascular events (MACE) or active tuberculosis were reported. Incidence of uveitis and adjudicated inflammatory bowel disease was low.ConclusionsDual inhibition of IL-17A and IL-17F with bimekizumab resulted in significant and rapid improvements in efficacy outcomes vs placebo and was well tolerated in patients with nr-axSpA and r-axSpA.

• Publisher: BMJ Publishing Group Ltd and European League Against Rheumatism,Elsevier Limited,BMJ Publishing Group
• Subject: Analysis of covariance / Ankylosing spondylitis / Arthritis / Autoimmune Diseases / Biological Therapy / C-reactive protein / Candidiasis / Classification / Clinical trials / Cytokines / Diarrhea / Double-Blind Method / Humans / Inflammation / Inflammatory bowel diseases / Inflammatory diseases / Interleukin-17 / Joint diseases / Monoclonal antibodies / Non-Radiographic Axial Spondyloarthritis / Patients / Pharyngitis / Placebos / Randomized Controlled Trials as Topic / Respiratory tract diseases / Rheumatic diseases / Rhinopharyngitis / Sacroiliitis / Spondylarthritis - drug therapy / Spondylitis, Ankylosing / Spondylitis, Ankylosing - drug therapy / Spondyloarthritis / Treatment Outcome / Tumor necrosis factor-TNF / Uveitis