VUNAKIZUMAB significantly improved clinical symptoms in patients with active radiographic axial spondyloarthritis, with benefits sustained through 32 weeks and a safety profile comparable to placebo in a large randomised clinical trial conducted across China.
Exploring New IL-17 Therapies for axSpA
Radiographic axial spondyloarthritis remains difficult to manage for many patients who experience inadequate responses or intolerance to existing therapies. Researchers therefore investigated whether vunakizumab, a novel monoclonal antibody targeting interleukin 17A, could provide sustained disease control and symptom improvement in active disease.
Phase 2 to 3 Trial Evaluated Vunakizumab Dosing
This randomised, double-blind, placebo-controlled phase 2 to 3 clinical trial was conducted across 38 hospitals in China between June 2021 and March 2023. A total of 548 adults aged 18 years or older with active radiographic axial spondyloarthritis were enrolled. During phase 2, participants were randomised 2:2:1 to subcutaneous vunakizumab 120 mg, vunakizumab 240 mg, or placebo. Interim analyses identified 120 mg as the recommended dose. In phase 3, participants were randomised 2:1 to receive vunakizumab 120 mg or placebo at Weeks 0, 2, 4, 8, and 12. From Week 16 onward, all participants received vunakizumab 120 mg every four weeks through Week 32.
Clinical Responses Improved with Vunakizumab
Overall, 294 patients received vunakizumab 120 mg and 146 received placebo. At Week 16, ASAS20 response rates were significantly higher with vunakizumab versus placebo, achieved in 193 patients (65.6%) compared with 62 patients (42.5%), corresponding to a difference of 23.2% (95% CI 11.8%–34.0%; P<0.001). ASAS40 response rates also favoured vunakizumab, occurring in 136 patients (46.3%) versus 35 patients (24.0%) receiving placebo, with difference 22.3% (95% CI 13.3%–31.3%; P<0.001). Clinical improvements were maintained through Week 32. During the placebo-controlled period, adverse events occurred in 83.7% of vunakizumab-treated patients and 81.5% of placebo recipients.
Potential New Treatment Option for axSpA
Researchers concluded that vunakizumab produced significant and sustained improvements in signs and symptoms of radiographic axial spondyloarthritis with acceptable tolerability. The findings support further development of vunakizumab as a potential treatment option for interleukin 17-mediated inflammatory diseases.
Reference
Zhu J et al. Vunakizumab for radiographic axial spondyloarthritis: a randomized clinical trial. JAMA Netw Open. 2026;9(5):e2611632.
Featured image: Viacheslav Yakobchuk on Adobe Stock
