Spondyloarthritis & psoriatic arthritis
Efficacy and safety of izokibep in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study
Authors' conclusion
Izokibep resulted in significant and clinically meaningful improvements over placebo across multiple disease domains, and the originally randomised 80-mg dose showed continued improvements to week 46. There were no unexpected safety risks identified.
Study context
- Population
- Adults with active psoriatic arthritis (PsA)172 screened
- Participants
- 135 adults
- Comparison
- Izokibep 40 mg or 80 mg every 2 weeks vs placebo for 16 weeks
- Izokibep 40 mgn = 44
- Izokibep 80 mgn = 47
- Placebon = 44reference
- Primary endpoint
- ACR50, izokibep 80 mg vs placebo
- Follow-up
- Week 16
Methodological detailsphase 2, multicentre, double-blind, placebo-controlled
- Phase 2
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
ACR50 response
2-sided P = .0006
Further findings
ACR50 response · week 12 — Izokibep 80 mg vs Placebo
P < 0.0001
Arthritis, psoriasis, enthesitis, dactylitis and quality of life outcomes
- Supported the efficacy of izokibep at both doses
Response rates with izokibep 80 mg · week 46
- Generally continued to increase through week 46
Safety
Treatment-emergent adverse events
- Generally similar across treatment groups except for injection site reactions
Original publication
Efficacy and safety of izokibep in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Ann Rheum Dis. Published 11 April 2025. doi:10.
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