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

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

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Abstract

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.
Original languageEnglish
Pages (from-to)515-526
Number of pages12
JournalAnnals of the Rheumatic Diseases
Volume82
Issue number4
Early online date17 Jan 2023
DOIs
Publication statusPublished - 1 Apr 2023

Keywords

  • Autoimmune Diseases
  • Biological Therapy
  • Cytokines
  • Inflammation
  • Spondylitis, Ankylosing

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