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

van der Heijde, Désirée, Deodhar, Atul, Baraliakos, Xenofon, Brown, Matthew A., Dobashi, Hiroaki, Dougados, Maxime, Elewaut, Dirk, Ellis, Alicia M., Fleurinck, Carmen, Gaffney, Karl ORCID: https://orcid.org/0000-0002-7863-9176, Gensler, Lianne S., Haroon, Nigil, Magrey, Marina, Maksymowych, Walter P., Marten, Alexander, Massow, Ute, Oortgiesen, Marga, Poddubnyy, Denis, Rudwaleit, Martin, Shepherd-Smith, Julie, Tomita, Tetsuya, van den Bosch, Filip, Vaux, Thomas and Xu, Huji (2023) Efficacy and safety of bimekizumab in axial spondyloarthritis: Results of two parallel phase 3 randomised controlled trials. Annals of the Rheumatic Diseases, 82 (4). pp. 515-526. ISSN 0003-4967

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Objectives: Axial 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. Methods: In 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. Results: 254 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. Conclusions: Dual 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.

Item Type: Article
Additional Information: Funding Information: The authors thank the patients and their caregivers in addition to all the investigators and their teams who contributed to these studies. The authors also acknowledge Natasha de Peyrecave, DPhil, UCB Pharma, Brussels, Belgium for substantial contributions to this publication, Celia Menckeberg, PhD, UCB Pharma, Breda, The Netherlands for publication coordination and editorial assistance, and Evelyn Turner, BSc, Costello Medical, Cambridge, UK for medical writing and editorial assistance based on the authors’ input and direction. These trials were funded by UCB Pharma. Funding Information: This article was based on the original trials BE MOBILE 1 ( NCT03928704 ) and BE MOBILE 2 ( NCT03928743 ) which were sponsored by UCB Pharma. Support for third party medical writing assistance for this article, provided by Evelyn Turner, BSc, Costello Medical, Cambridge, UK was funded by UCB Pharma in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ). Publisher Copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Uncontrolled Keywords: autoimmune diseases,biological therapy,cytokines,inflammation,spondylitis, ankylosing,rheumatology,immunology and allergy,immunology,biochemistry, genetics and molecular biology(all),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2745
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 01 Sep 2023 10:30
Last Modified: 04 Sep 2023 01:12
URI: https://ueaeprints.uea.ac.uk/id/eprint/92969
DOI: 10.1136/ard-2022-223595


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