Vunakizumab Shows Sustained Efficacy in Radiographic Axial Spondyloarthritis: JAMA
China: In a randomized clinical trial, vunakizumab 120 mg significantly improved the signs and symptoms of active radiographic axial spondyloarthritis (r-axSpA) compared with placebo at 16 weeks, with benefits maintained through 32 weeks. The treatment demonstrated a tolerable safety profile, supporting vunakizumab as a promising new option for r-axSpA and other IL-17–mediated inflammatory diseases.
The findings, published in JAMA Network Open by Jian Zhu and colleagues, address the need for new treatment options for radiographic axial spondyloarthritis, a chronic inflammatory condition that can cause persistent pain, stiffness, and impaired mobility.
Vunakizumab is a novel monoclonal antibody targeting interleukin-17A (IL-17A), a key driver of inflammation in spondyloarthritis. To evaluate its efficacy and safety, researchers conducted a randomized, double-blind, placebo-controlled phase 2–3 trial across 38 hospitals in China.
The study enrolled 548 adults with active r-axSpA between June 2021 and March 2023. Following interim analyses, the 120-mg dose of vunakizumab was selected for further evaluation. Patients received either vunakizumab 120 mg or placebo through week 16, after which all participants were treated with vunakizumab every four weeks until week 32.
The primary endpoint was the proportion of patients achieving an ASAS20 response at week 16, while secondary endpoints included ASAS40 responses, disease activity, physical function, spinal mobility, and quality-of-life measures.
The trial revealed the following findings:
- At week 16, the ASAS20 response rate was 65.6% in the vunakizumab group compared with 42.5% in the placebo group.
- Vunakizumab increased the ASAS20 response rate by 23.2 percentage points versus placebo.
- The ASAS40 response rate at week 16 was 46.3% with vunakizumab compared with 24.0% with placebo.
- Vunakizumab improved the ASAS40 response rate by 22.3 percentage points compared with placebo.
- Clinical responses achieved with vunakizumab were maintained through week 32.
- Adverse events occurred in 83.7% of patients receiving vunakizumab and 81.5% of those receiving placebo during the placebo-controlled period.
- The incidence of adverse events was comparable between the vunakizumab and placebo groups.
- No unexpected safety concerns were identified, indicating a manageable and well-tolerated safety profile.
The researchers acknowledged several limitations, including the 32-week follow-up period, the lack of an active biologic comparator, and the inclusion of only Chinese patients, which may affect the generalizability of the findings. Additionally, radiographic outcomes were not assessed, leaving the drug’s effect on long-term structural disease progression unclear.
Overall, the findings suggest that vunakizumab 120 mg provides sustained improvements in disease signs and symptoms with a manageable safety profile, supporting its potential as a new treatment option for active radiographic axial spondyloarthritis.
Reference:
Zhu J, Zhao C, Mi C, et al. Vunakizumab for Radiographic Axial Spondyloarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2026;9(5):e2611632. doi:10.1001/jamanetworkopen.2026.11632
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