Background
Vunakizumab (SHR-1314) is a novel humanized monoclonal IgG1/k antibody targeting IL-17A, previously showing efficacy in treating plaque psoriasis. Given the overlap in symptoms between psoriasis and ankylosing spondylitis (AS), a phase 2/3 trial was conducted to evaluate its efficacy and safety in AS.
Methods
This randomized, double-blind, adaptive, seamless study (NCT04840485) involved patients with active AS and inadequate response to NSAIDs. Patients were randomized to receive vunakizumab 120 mg, 240 mg, or placebo, with a pre-planned interim analysis determining the recommended phase 3 dose.
Results
A total of 548 patients were randomized, with significant improvements in ASAS20 response rates at week 16 for vunakizumab 120 mg compared to placebo (65.6% vs 42.5%, P <0.0001). The efficacy was sustained through 32 weeks, with a tolerable safety profile and no serious infections, malignancies, or deaths reported.
Conclusion
Vunakizumab 120 mg significantly improved signs and symptoms of ankylosing spondylitis at week 16 versus placebo, with sustained efficacy through 32 weeks. The safety profile was tolerable, supporting vunakizumab 120 mg as a new treatment option for active ankylosing spondylitis.
