Journal Article

Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies

Maksymowych, Walter P, Xu, Huji, Marten, Alexander, Ellis, Alicia M, van der Heijde, Désirée, Magrey, Marina, Baraliakos, Xenofon, Massow, Ute, Shepherd-Smith, Julie, Deodhar, Atul, Fleurinck, Carmen, Gensler, Lianne S, Tomita, Tetsuya, Vaux, Thomas

2024

Overview

ObjectivesBimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated superior efficacy versus placebo in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) at Week 16. Here, the objective is to report the efficacy and safety of BKZ at Week 52.MethodsBE MOBILE 1 (nr-axSpA; NCT03928704) and BE MOBILE 2 (r-axSpA; NCT03928743) comprised a 16-week, double-blind, placebo-controlled period, then a 36-week maintenance period. From Week 16, all patients received subcutaneous BKZ 160 mg every 4 weeks.ResultsImprovements versus placebo in Assessment of SpondyloArthritis International Society ≥40% response (primary endpoint), Ankylosing Spondylitis Disease Activity Score, high-sensitivity C-reactive protein levels and MRI inflammation of the sacroiliac joints/spine at Week 16 were sustained to Week 52 in BKZ-randomised patients. At Week 52, responses of patients switching from placebo to BKZ at Week 16 were comparable to BKZ-randomised patients. At Week 52, ≥1 treatment-emergent adverse events (TEAEs) were reported in 183 (75.0%) and 249 (75.5%) patients with nr-axSpA and r-axSpA, respectively. Serious TEAEs occurred in 9 (3.7%) patients with nr-axSpA and 20 (6.1%) patients with r-axSpA. Oral candidiasis was the most frequent fungal infection (nr-axSpA: 18 (7.4%); r-axSpA: 20 (6.1%)). Uveitis occurred in three (1.2%) and seven (2.1%) patients with nr-axSpA and r-axSpA, and inflammatory bowel disease in two (0.8%) and three (0.9%).ConclusionsAt Week 52, dual inhibition of IL-17A and IL-17F with BKZ resulted in sustained efficacy across the axSpA spectrum; the safety profile was consistent with the known safety of BKZ.Trial registration numberNCT03928704; NCT03928743.

• Publisher: BMJ Publishing Group Ltd and European League Against Rheumatism,Elsevier Limited
• Subject: Ankylosing spondylitis / Antibodies, Monoclonal, Humanized / Arthritis / autoimmune diseases / biological therapy / C-reactive protein / Candidiasis / Clinical outcomes / Cytokines / Double-Blind Method / Drug dosages / Drug withdrawal / Humans / Immunoglobulin G / Inflammation / Inflammatory bowel diseases / Inflammatory diseases / Interleukin-17 / Joint diseases / Kinases / Missing data / Monoclonal antibodies / Non-Radiographic Axial Spondyloarthritis / Pathogenesis / Patients / Placebos / Psoriasis / Quality of life / Rheumatic diseases / Sacroiliitis / Safety / Spondylarthritis - diagnostic imaging / Spondylarthritis - drug therapy / spondylitis, ankylosing / Spondylitis, Ankylosing - drug therapy / Spondyloarthritis / Statistical analysis / Treatment Outcome / Uveitis