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Vunakizumab improves ASAS20 response in active radiographic axial spondyloarthritis at 16 weeksNew Drug Offers Hope for Ankylosing Spondylitis Patients

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Key Takeaway
Consider vunakizumab 120 mg as a potential new option for active radiographic axial spondyloarthritis based on this trial.

This randomized, double-blind, placebo-controlled phase 2 to 3 clinical trial enrolled 548 adult patients aged 18 years or older with active radiographic axial spondyloarthritis at 38 hospitals in China. Patients received subcutaneous vunakizumab 120 mg, vunakizumab 240 mg (phase 2), or placebo, with a follow-up of 32 weeks.

The primary outcome was the proportion of patients with an ASAS20 response at week 16. The vunakizumab 120 mg group had a significantly higher response rate than placebo (193 [65.6%] vs 62 [42.5%]), with an absolute difference of 23.2% (95% CI, 11.8% to 34.0%; P < .001).

Secondary outcomes showed that the ASAS40 response rate at weeks 16 and 32 also favored vunakizumab 120 mg (136 [46.3%] vs 35 [24.0%]), with an absolute difference of 22.3% (95% CI, 13.3% to 31.3%; P < .001). Responses were sustained through 32 weeks. The incidence of adverse events was comparable between the vunakizumab 120 mg and placebo groups (246 [83.7%] vs 119 [81.5%]), demonstrating a tolerable safety profile.

Key limitations include the lack of reported serious adverse events or discontinuations, and the absence of funding or conflict disclosures. The practice relevance supports vunakizumab 120 mg as a new treatment option for active r-axSpA, but these findings require confirmation in larger trials.

What This Drug Does Differently

Ankylosing spondylitis happens when your immune system attacks your own body. It causes inflammation (swelling) in your spine and joints.

Most treatments try to calm this immune response. But they do not all work the same way.

Here is the twist. Vunakizumab targets a specific protein in your body called interleukin-17A (IL-17A). Think of IL-17A as a fire alarm that keeps ringing. It tells your immune system to keep attacking. Vunakizumab acts like someone who pulls the battery out of that alarm. It blocks the signal.

This is not a completely new idea. Other drugs already target IL-17A. But vunakizumab is a new version. It is what doctors call a monoclonal antibody. That is just a lab-made protein designed to find and block a specific target in your body.

The study involved 548 adults with active ankylosing spondylitis. All of them had tried other treatments that did not work well enough.

Researchers split them into groups. One group got vunakizumab. Another group got a placebo (a shot with no medicine). Neither the patients nor the doctors knew who got what.

After 16 weeks, the difference was clear.

About 65% of people taking vunakizumab felt at least 20% better. Only 42% of the placebo group could say the same. That is a 23% difference.

Even more impressive, 46% of the drug group felt at least 40% better. Only 24% of the placebo group reached that level.

These results held up for 32 weeks with continued treatment.

Patients also reported less stiffness, better physical function, and improved quality of life.

But There Is a Catch

The drug is not available yet. This was a phase 2 to 3 clinical trial. That means it is still being tested for safety and effectiveness.

The good news is that side effects were similar between the drug group and the placebo group. That suggests the drug is well tolerated. But longer studies are needed to know for sure.

Also, this study was done in China. More research in different populations will help confirm the results.

If you have ankylosing spondylitis and current treatments are not working well enough, this is a hopeful sign. A new option may be coming.

But do not expect to get vunakizumab at your pharmacy tomorrow. The drug still needs regulatory approval. That process can take months or even years.

In the meantime, talk to your rheumatologist (a doctor who treats arthritis). Ask about existing IL-17A blockers that are already approved. They work in a similar way.

What Happens Next

The researchers plan to continue studying vunakizumab. They want to see how well it works over longer periods. They also need to watch for rare side effects that might not show up in smaller studies.

Drug development takes time for a reason. Safety comes first. But for the millions of people living with ankylosing spondylitis, this study offers a real reason to stay hopeful.

Study Details

Study typeRct
Sample sizen = 2
EvidenceLevel 2
Follow-up216.0 mo
PublishedMay 2026
View Original Abstract ↓
IMPORTANCE: A notable proportion of patients with ankylosing spondylitis (ie, radiographic axial spondyloarthritis [r-axSpA]) experience either inadequate responses or intolerance to available therapies, highlighting the need for additional treatment options that offer sustained disease control. OBJECTIVE: To evaluate the efficacy and safety of vunakizumab, a novel anti-interleukin (IL) 17A monoclonal antibody, in r-axSpA. DESIGN, SETTING, AND PARTICIPANTS: This randomized, double-blind, placebo-controlled, phase 2 to 3 clinical trial was conducted in 38 hospitals in China. A total of 548 adult patients (aged ≥18 years) with active r-axSpA were enrolled between June 9, 2021, and March 30, 2023. Data were analyzed from November 3, 2023, to January 14, 2024. INTERVENTIONS: In phase 2, patients were randomized 2:2:1 to receive a subcutaneous dose of vunakizumab, 120 mg, vunakizumab, 240 mg, or placebo; vunakizumab, 120 mg was determined to be the recommended dose after interim analysis. In phase 3, patients were randomized 2:1 to receive vunakizumab, 120 mg or placebo at weeks 0, 2, 4, 8, and 12; from week 16, all patients received vunakizumab, 120 mg every 4 weeks through week 32. MAIN OUTCOMES AND MEASURES: The primary end point was the proportion of patients with improvement of 20% or greater in Assessment of Spondyloarthritis International Society response criteria (ASAS20) at week 16. Secondary end points were ASAS20 at week 32, improvement of 40% or greater in ASAS response criteria (ASAS40) at weeks 16 and 32, improvement of 20% or greater in 5 of 6 ASAS domains (ASAS5/6) at weeks 16 and 32, and changes from baseline at weeks 16 and 32 in Bath Ankylosing Spondylitis Disease Activity Index score, Bath Ankylosing Spondylitis Functional Index score, Bath Ankylosing Spondylitis Metrology Index score, 36-Item Short Form Survey score, and Ankylosing Spondylitis Quality of Life Questionnaire score. RESULTS: During the entire study, 548 patients were randomized (mean [SD] age, 33.0 [8.9] years; 440 [80.3%] male), including 294 receiving vunakizumab, 120 mg and 146 receiving placebo. At week 16, the ASAS20 response rate was significantly higher with vunakizumab, 120 mg vs placebo (193 [65.6%] vs 62 [42.5%], respectively; difference, 23.2% [95% CI, 11.8%-34.0%]; P < .001); the ASAS40 response rate also favored vunakizumab, 120 mg vs placebo (136 [46.3%] vs 35 [24.0%], respectively; difference, 22.3% [95% CI, 13.3%-31.3%]; P < .001). Responses with vunakizumab were sustained through 32 weeks. During the placebo-controlled period, incidence of adverse events (246 [83.7%] vs 119 [81.5%]) were comparable in the vunakizumab, 120 mg and placebo groups. CONCLUSIONS AND RELEVANCE: 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. These findings support vunakizumab, 120 mg as a new treatment option for active r-axSpA. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04840485.
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