Spondyloarthritis & psoriatic arthritis
Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL)
Primary result · ACR50 responseResult — go to the resultOdds ratio 7.1 95% CI 4.6–10.9Authors' conclusion
Bimekizumab treatment had superior improvements in joint, skin, and radiographic efficacy outcomes at week 16 compared with placebo in patients with psoriatic arthritis who were naive to biologic DMARDs.
Study context
- Population
- Adults (≥18 years) with active adult-onset PsA meeting Classification Criteria for Psoriatic Arthritis for ≥6 months, naive to bDMARDs; 135 sites in 14 countries1,163 screened
- Participants
- 852 adults
- Comparison
- Bimekizumab 160 mg every 4 weeks vs placebo, with adalimumab 40 mg every 2 weeks as active reference
- Bimekizumabn = 431
- Placebon = 281reference
- Adalimumabn = 140
- Primary endpoint
- Proportion reaching ACR50 (non-responder imputation)
- Follow-up
- Up to week 16
Methodological detailsphase 3, multicentre, double-blind, placebo-controlled, active reference (adalimumab), 3:2:1 randomisation, stratified by region and bone erosion number, Data presented to week 24 (preplanned analysis)
- Phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- Active reference (adalimumab)
- 3:2:1 randomisation, stratified by region and bone erosion number
- Data presented to week 24 (preplanned analysis)
Primary result
ACR50 response
Odds ratio
7.1
95% CI 4.6–10.9
P < 0.0001
Events by treatment group
Bimekizumabvs Placebo
OR 7.1 (95% CI 4.6–10.9); P < 0.0001
As reported in the abstract
Further findings
Secondary hierarchical endpoints
- All secondary hierarchical endpoints were met
Deaths
- No deaths occurred
Safety
Treatment-emergent adverse events · up to week 16
Original publication
Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. Published 6 December 2022. doi:10.
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