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TOPLINE:

In a randomized phase 2-3 trial, vunakizumab, a novel anti-interleukin-17A monoclonal antibody, demonstrated superior efficacy than placebo in patients with radiographic axial spondyloarthritis by week 16, with a rapid onset by week 4, sustained benefit through week 32, and a tolerable safety profile.

METHODOLOGY:

• Researchers conducted a phase 2-3 clinical trial in 38 hospitals in China between June 2021 and March 2023 to evaluate the efficacy and safety of vunakizumab in adult patients with active radiographic axial spondyloarthritis.
• Overall, 548 patients (mean age, 33 years; 19.7% women) were enrolled; eligibility required a Bath Ankylosing Spondylitis Disease Activity Index score ≥ 4 and a total back pain score ≥ 4 on a 10-cm visual analog scale at screening and baseline, radiographic sacroiliitis confirmed locally by a radiologist and a clinician, and inadequate response to at least two nonsteroidal anti-inflammatory drugs at recommended doses for a total of 4 weeks, or a contraindication or intolerance to these drugs.
• Participants in phase 2 were randomly assigned to subcutaneously receive vunakizumab 120 mg (n = 108), vunakizumab 240 mg (n = 108), or placebo (n = 54) at weeks 0, 2, 4, 8, and 12; those who completed week 16 entered an extension phase through week 32 in which patients originally assigned to placebo were re-randomly assigned at week 16 to receive vunakizumab 120 or 240 mg every 4 weeks and those initially assigned to vunakizumab continued treatment every 4 weeks.
• Patients in phase 3 were randomly assigned to subcutaneously receive either vunakizumab 120 mg (n = 186) or placebo (n = 92) at weeks 0, 2, 4, 8, and 12; from week 16, all patients received vunakizumab 120 mg every 4 weeks through week 32.
• The primary outcome was the achievement of at least a 20% improvement in the Assessment of Spondyloarthritis International Society (ASAS20) response criteria at week 16.

TAKEAWAY:

• At week 16, vunakizumab 120 mg demonstrated a superior ASAS20 response rate than placebo (65.6% vs 42.5%; difference, 23.2%; P < .001); a higher proportion of patients achieved at least a 40% improvement in ASAS (ASAS40) with vunakizumab 120 mg vs placebo (46.3% vs 24.0%; one-sided nominal P < .001).
• The response to vunakizumab 120 mg was rapid: By week 2, 34.0% of patients who received vunakizumab 120 mg vs 11.6% of those who received placebo achieved an ASAS20 response, increasing by week 4 to 48.6% vs 26.0%; response rates continued to increase through week 32 in patients receiving continuous vunakizumab, reaching 77.0% (95% CI, 72.1%-81.9%) for ASAS20 and 62.2% (95% CI, 56.5%-67.8%) for ASAS40.
• Vunakizumab 120 mg vs placebo showed a consistent benefit across baseline subgroups regardless of prior anti-TNF therapy, with an ASAS20 response rate of 67.3% vs 44.6% in patients with prior anti-TNF therapy and 64.7% vs 41.1% in those without.
• During the placebo-controlled period, the incidence of adverse events was comparable between vunakizumab 120 mg and placebo groups (83.7% vs 81.5%), with most events being mild or moderate in intensity.

IN PRACTICE:

“[The study] data support rapid and durable improvements in disease manifestations with vunakizumab, 120 mg in treating [radiographic axial spondyloarthritis],” the authors wrote.

SOURCE:

This study was led by Jian Zhu, MD, Department of Rheumatology and Immunology, Chinese People’s Liberation Army General Hospital, Beijing, China. It was published online on May 8, 2026, in JAMA Network Open.

LIMITATIONS:

This study evaluated only a 32-week treatment period for vunakizumab. The study did not include an active comparator, precluding direct comparisons with other biologic disease-modifying antirheumatic drugs. The study only included patients from China, and generalizability to other geographic regions and ethnic groups requires further investigation.

DISCLOSURES:

Jiangsu Hengrui Pharmaceuticals provided support for this study. Four authors disclosed having employment at Jiangsu Hengrui Pharmaceuticals outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.