Trial reportRheumatology (Oxford, England)2025
Long-term safety and efficacy of bimekizumab in axial spondyloarthritis: 2-year results from two phase 3 studies.
Trial report in Rheumatology (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis
Who cites it
11 citing papers in PubMed.
- Bimekizumab efficacy in male and female patients with axial spondyloarthritis: 52-week results from the phase 3 BE MOBILE trials.Rheumatology (Oxford, England) · 2026Trial
- Trial
- Bimekizumab safety and efficacy in patients with psoriatic arthritis: 3-year results from two phase 3 studies.Rheumatology (Oxford, England) · 2026Trial
- Trial
- Impact of symptom duration on the short- and long-term efficacy of bimekizumab in axial spondyloarthritis: results up to 2 years.Arthritis research & therapy · 2026Trial
- Trial
- Sustained resolution of enthesitis and peripheral arthritis over 104 weeks with bimekizumab in axial spondyloarthritis.RMD open · 2025Trial
- Clinical and MRI remission in axial spondyloarthritis: one-year outcomes and predictors from the TRACE treat-to-target study with secukinumab.Arthritis research & therapy · 2026Article
- Year in Review: Axial Spondyloarthritis.Mediterranean journal of rheumatology · 2026Review
- Current and Emerging Therapies for Uveitis in Axial Spondyloarthritis: A Scoping Review.Mediterranean journal of rheumatology · 2026Review
- Biologic and targeted synthetic therapies in ankylosing spondylitis: a pharmacological review.Frontiers in pharmacology · 2026Review
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
objectivesBimekizumab, a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, previously demonstrated efficacy and was well tolerated to 1 year in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA). Here, we report bimekizumab safety and efficacy to 2 years.
methodsPatients completing week 52 in the phase 3 studies BE MOBILE 1 (nr-axSpA; NCT03928704) and 2 (r-axSpA; NCT03928743) were eligible for an ongoing open-label extension (OLE; NCT04436640). All OLE patients received subcutaneous bimekizumab 160 mg every 4 weeks. Safety outcomes for patients who received ≥1 bimekizumab dose, and efficacy outcomes for all randomized patients, are reported to week 104.
resultsIn the OLE (weeks 52 - 104), 70.8% (367/518) of patients reported ≥1 treatment-emergent adverse event (TEAE). Most frequent TEAEs [exposure-adjusted incidence rate per 100 patient-years (EAIR/100PY)] were SARS-CoV-2 (COVID-19) infection (25.2), nasopharyngitis (11.0) and oral candidiasis (5.4). Fungal infection EAIR/100PY was 11.8 (majority Candida infections: 6.8; most mild/moderate, none serious/systemic). Inflammatory bowel disease and uveitis rates were low; no major adverse cardiovascular events or deaths occurred. TEAE incidence rate was generally similar across weeks 0 - 52 and 52 - 104.At week 104, >50% of randomized patients (N = 586) achieved Assessment of SpondyloArthritis international Society 40% response (ASAS40); ∼60% achieved Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity (<2.1) and >30% achieved ASDAS inactive disease (<1.3). Bimekizumab demonstrated sustained suppression of MRI inflammation at week 104, with >57% of patients achieving MRI remission.
conclusionsThe safety profile of bimekizumab remained consistent with prior reports, with no new safety signals identified. 1-year efficacy was sustained to 2 years across patients with nr-axSpA and r-axSpA.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.