Spondyloarthritis & psoriatic arthritis
Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials
An erratum to this article was published (Ann Rheum Dis, Sep 2023 ↗)
Authors' conclusion
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.
Study context
- Population
- Patients with active nr-axSpA (BE MOBILE 1; randomised 1:1) or r-axSpA (BE MOBILE 2; randomised 2:1)254 nr-axSpA, 332 r-axSpA
- Comparison
- Bimekizumab 160 mg every 4 weeks vs placebo
- Primary endpoint
- ASAS40
- Follow-up
- Week 16
Methodological detailstwo parallel phase 3 trials, double-blind, placebo-controlled to week 16, 52-week trials
- Two parallel phase 3 trials
- Double-blind
- Placebo-controlled to week 16
- 52-week trials
Primary result
As reported in the abstract
P < 0.001
Secondary outcomes
All ranked secondary endpoints · week 16
- Met in both trials
ASAS40 by TNFi status (subgroup)
- Similar across TNFi-naïve and TNFi-inadequate responder patients
Ankylosing Spondylitis Disease Activity Score (ASDAS) states and objective inflammation (high-sensitivity C-reactive protein (hs-CRP), MRI of sacroiliac joints and spine)
- Improvements observed
Safety
Most frequent treatment-emergent adverse events (TEAEs) with bimekizumab (>3%) · up to week 24
- Nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis
Fungal infections
- More with bimekizumab vs placebo (all localised)
Major adverse cardiovascular events (MACE) and active tuberculosis
- None reported
Uveitis and adjudicated inflammatory bowel disease
- Low incidence
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →