Spondyloarthritis & psoriatic arthritis
Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies
Authors' conclusion
Bimekizumab treatment resulted in rapid and sustained clinically meaningful improvements in disease impact up to 1 year in bDMARD-naïve and TNFi-IR patients with PsA.
Study context
- Population
- Patients with PsA, bDMARD-naïve (BE OPTIMAL) or TNFi-IR (BE COMPLETE)
- Participants
- 1,112 patients
- Comparison
- Bimekizumab 160 mg every 4 weeks vs placebo switched to bimekizumab at Week 16
- Bimekizumabn = 698
- Placebo/bimekizumabn = 414reference
- Primary endpoint
- Change from baseline in PsAID-12 total score (patient-reported disease impact)
- Follow-up
- Up to 1 year
Methodological detailsBE VITAL
- BE VITAL
Primary result
As reported in the abstract
Bimekizumab (bDMARD-naïve)
−2.3
mean · SE 0.1
Placebo/bimekizumab (bDMARD-naïve)
−2.2
mean · SE 0.1
Bimekizumab (TNFi-IR)
−2.5
mean · SE 0.1
Placebo/bimekizumab (TNFi-IR)
−2.2
mean · SE 0.2
Further findings
Clinically meaningful within-patient improvement (≥3-point decrease in PsAID-12) · up to 1 year
Clinically meaningful within-patient improvement (≥3-point decrease in PsA Impact of Disease (PsAID-12)) · up to 1 year
- Week 16 response in bimekizumab-randomised patients sustained to 1 year; similar for placebo/bimekizumab
Minimal or no symptom impact, across studies and arms · up to 1 year
- Proportion of patients
- 35.3% to 47.8%
Single-item domains (incl. pain, fatigue, skin problems) · up to 1 year
- Improvements observed across all single-item domains
Original publication
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