Trial reportRheumatology (Oxford, England)2026
Bimekizumab efficacy in male and female patients with axial spondyloarthritis: 52-week results from the phase 3 BE MOBILE trials.
Trial report in Rheumatology (Oxford, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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
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Authors and funding
10 authors.
Funding
Abstract
objectivesTo assess sex-based differences in response to bimekizumab in patients with axial spondyloarthritis (axSpA) from two phase 3 trials.
methodsImprovements to week 52 in measures of disease activity (ASAS40, ASDAS <2.1, BASDAI) and function (BASFI), pain, fatigue, health-related quality of life (HRQoL) and objective signs of inflammation (MRI, hs-CRP) were assessed post hoc in patients with non-radiographic (nr-) and radiographic (r-)axSpA from BE MOBILE 1 (NCT03928704) and BE MOBILE 2 (NCT03928743), respectively. Comparisons were made between sexes at week 16 (bimekizumab vs placebo treatment effect) and week 52 (treatment response in bimekizumab-randomized patients only) using odds ratios for dichotomous outcomes and difference values for continuous outcomes. For hs-CRP, ratio to baseline was calculated due to skewed distribution.
resultsWhile sex distribution was balanced in nr-axSpA (54.3% male), 72.3% of patients with r-axSpA were male. At week 16, bimekizumab-randomized male patients typically had better treatment responses vs placebo compared with female patients across ASAS40, ASDAS <2.1 and improvements in BASDAI, BASFI and measures of HRQoL. At week 52, female patients had longer-term improvements across these outcomes, though male patients continued to have numerically higher treatment responses. In contrast, active inflammation (MRI, hs-CRP) was reduced to similarly low levels in both sexes at week 16 and maintained to week 52, despite baseline differences.
conclusionAlthough male patients had earlier clinical responses to bimekizumab treatment, female patients demonstrated longer-term improvements in composite and patient-reported outcomes. Both sexes had substantial improvements in objective inflammation at week 16 and 52, despite baseline differences.
trial registrationClinicaltrials.gov; NCT03928704 and NCT03928743.
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