Spondyloarthritis & psoriatic arthritis
Bimekizumab treatment in biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study
An erratum to this article was published (Ann Rheum Dis, Feb 2026 ↗)
Authors' conclusion
The efficacy of BKZ in bDMARD-naïve patients with PsA was sustained from Week 16 to Week 52. BKZ was well tolerated with no new safety signals observed.
Study context
- Population
- bDMARD-naïve patients with active psoriatic arthritis (PsA)
- Comparison
- Bimekizumab (BKZ) 160 mg every 4 weeks vs placebo (PBO) (switch to BKZ at Week 16), with ADA 40 mg every 2 weeks as reference arm
Methodological detailsphase III, double-blind, PBO-controlled 16-week period, then 36 weeks treatment-blind, active reference (ADA), non-responder imputation
- Phase III
- Double-blind, PBO-controlled 16-week period, then 36 weeks treatment-blind
- Active reference (ADA)
- Non-responder imputation
Primary result
As reported in the abstract
Long-term efficacy (ACR20/50/70, PASI75/90/100, MDA) · Week 52
- ACR20/50/70, PASI75/90/100 and minimal disease activity (MDA) responses sustained with BKZ to Week 52, consistent with Week 16
- Patients switched to BKZ at Week 16 improved, with results similar to BKZ-randomised patients by Week 52
- Non-responder imputation
Further findings
- Death · to Week 52 · unrelated to treatment — BKZ
- 1 events
Safety
| Outcome | BKZ | ADA |
|---|---|---|
| ≥1 TEAE · to Week 52During BKZ treatment | 79.1% | 80.7% |
| Serious TEAEs · to Week 52 | 6.6% | — not stated in the abstract |
| Candida infections · to Week 52All cases localised and non-serious | 7.7% | 0.7% |
— not stated in the abstract
Original publication
Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. Published 11 September 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →