Spondyloarthritis & psoriatic arthritis
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
Authors' conclusion
At 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.
Study context
- Population
- Patients with active nr-axSpA (BE MOBILE 1) and r-axSpA (BE MOBILE 2)
- Comparison
- Bimekizumab (BKZ) 160 mg every 4 weeks vs placebo to Week 16, then all patients on BKZ
- Primary endpoint
- ASAS ≥40% response
- Follow-up
- Week 16
Methodological detailsphase 3, parallel, double-blind, placebo-controlled (16 weeks), 36-week maintenance period
- Phase 3
- Parallel
- Double-blind
- Placebo-controlled (16 weeks)
- 36-week maintenance period
Primary result
As reported in the abstract
Week 52
- Improvements vs placebo at Week 16 sustained to Week 52 in BKZ-randomised patients
- At Week 52, responses of patients switching from placebo to BKZ comparable to BKZ-randomised patients
Further findings
ASDAS, high-sensitivity CRP and MRI inflammation of sacroiliac joints/spine · Week 52
- Improvements vs placebo at Week 16 sustained to Week 52 in BKZ-randomised patients
Safety
≥1 TEAE · Week 52
Serious TEAEs · Week 52
Oral candidiasis (most frequent fungal infection) · Week 52
Uveitis · Week 52
Inflammatory bowel disease · Week 52
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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. Ann Rheum Dis. Published 11 January 2024. doi:10.
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