Spondyloarthritis & psoriatic arthritis
Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE)
Primary result · ACR50Result — go to the resultAdjusted odds ratio 11.1 95% CI 5.4–23.0Authors' conclusion
Bimekizumab treatment led to superior improvements in joint and skin efficacy outcomes at week 16 compared with placebo in patients with psoriatic arthritis and inadequate response or intolerance to TNFα inhibitors.
Study context
- Population
- Adults with active adult-onset PsA and inadequate response or intolerance to one or two TNFi; 92 sites in 11 countries556 screened
- Participants
- 400 adults
- Comparison
- Subcutaneous bimekizumab 160 mg every 4 weeks vs placebo
- Bimekizumabn = 267
- Placebon = 133reference
- Primary endpoint
- ACR50 (non-responder imputation)
- Follow-up
- Up to week 16
Methodological detailsphase 3, multicentre, double-blind, placebo-controlled, 2:1 randomisation, stratified by region and previous TNFi use
- Phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- 2:1 randomisation
- Stratified by region and previous TNFi use
Primary result
ACR50
Adjusted odds ratio
11.1
95% CI 5.4–23.0
P < 0.0001
Events by treatment group
Bimekizumabvs Placebo
aOR 11.1 (95% CI 5.4–23.0); P < 0.0001
As reported in the abstract
Secondary outcomes
| Outcome | Bimekizumab | Placebo | aOR (CI) | P value | |
|---|---|---|---|---|---|
| PASI90 in patients with psoriasis ≥3% body surface area at baseline · up to week 16 | 69% | 7% | 30.2 (12.4–73.9) | P < 0.0001 | |
| 0.050.21520Adjusted odds ratio (log scale) |
- Psoriasis Area and Severity Index (PASI90) in patients with psoriasis ≥3% body surface area at baseline: of 176 (bimekizumab) and 88 (placebo) with psoriasis ≥3% BSA
Deaths
- No new safety signals and no deaths
Safety
Treatment-emergent adverse events · up to week 16
- Treatment-emergent adverse events: placebo safety set n=132
Original publication
Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. Published 6 December 2022. doi:10.
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