Vunakizumab beneficial in axial spondyloarthritis

Treatment with vunakizumab appears to yield substantial improvements in signs and symptoms of radiographic axial spondyloarthritis (r-axSpA), as shown in a phase 2/3 trial.

The trial was conducted in China and involved 548 adult patients (mean age 33 years, 80.3 percent male) with active r-axSpA. In phase 2, interim data established vunakizumab 120 mg as the recommended dose.

In phase 3, patients were randomly assigned to receive vunakizumab 120 mg (n=294) or placebo (n=146) at weeks 0, 2, 4, 8, and 12. Starting at week 16, all patients received vunakizumab 120 mg every 4 weeks through week 32. Treatment was administered subcutaneously.

The primary endpoint of a ≥20-percent improvement in the Assessment of Spondyloarthritis International Society response criteria (ASAS20) at week 16 occurred in significantly more patients treated with vunakizumab than those who received placebo (65.6 percent vs 42.5 percent; difference, 23.2 percent, 95 percent confidence interval [CI], 11.8–34.0; p<0.001).

The proportion of patients who achieved a ≥40-percent improvement in ASAS response criteria (ASAS40) was also greater in the vunakizumab group than in the placebo group (46.3 percent vs 24 percent; difference, 22.3 percent, 95 percent CI, 13.3–31.3; p<0.001). Responses with vunakizumab were sustained through 32 weeks.

In terms of safety, the incidence of adverse events did not significantly differ between the vunakizumab and placebo groups, at 83.7 percent and 81.5 percent, respectively.