Spondyloarthritis & psoriatic arthritis
Vunakizumab for Radiographic Axial Spondyloarthritis: A Randomized Clinical Trial
Primary result · ASAS20 response rateResult — go to the resultDifference 23.2% 95% CI 11.8%–34.0%Authors' conclusion
In this randomized clinical trial of patients with r-axSpA, vunakizumab, 120 mg significantly improved signs and symptoms of r-axSpA at week 16 compared with placebo, with sustained efficacy through 32 weeks, and demonstrated a tolerable safety profile.
Study context
- Population
- Adults (≥18 years) with active r-axSpA, 38 hospitals in Chinaincl
- Participants
- 548 adults
- Comparison
- Vunakizumab 120 mg subcutaneously vs placebo
- Vunakizumab, 120 mgn = 294
- Placebon = 146reference
- Primary endpoint
- Proportion of patients with ASAS20 response
- Follow-up
- Week 16
Methodological detailsdouble-blind, placebo-controlled, phase 2 to 3, multicentre (38 hospitals), Phase 2 randomised 2:2:1 (vunakizumab 120 mg, 240 mg, placebo); 120 mg chosen after interim analysis; phase 3 randomised 2:1
- Double-blind
- Placebo-controlled
- Phase 2 to 3
- Multicentre (38 hospitals)
- Phase 2 randomised 2:2:1 (vunakizumab 120 mg, 240 mg, placebo); 120 mg chosen after interim analysis; phase 3 randomised 2:1
Primary result
ASAS20 response rate
Difference
23.2%
95% CI 11.8%–34.0%
P < 0.001
Events by treatment group
Vunakizumab, 120 mgvs Placebo
difference 23.2% (95% CI 11.8%–34.0%); P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Vunakizumab, 120 mg | Placebo | Difference (95% CI) | P value | |
|---|---|---|---|---|---|
| ASAS40 response rate · week 16 | 46.3% | 24.0% | 22.3% (13.3%–31.3%) | P < 0.001 | |
| −2002040Difference (linear scale) |
Durability of response · 32 weeks
- Responses with vunakizumab were sustained through 32 weeks
Safety
Adverse events · placebo-controlled period · comparable
Original publication
Vunakizumab for Radiographic Axial Spondyloarthritis: A Randomized Clinical Trial. JAMA Netw Open. Published 1 May 2026. doi:10.
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