Firsekibart Shows Sustained 48-Week Response in Acute Gout

Key Takeaways

• Firsekibart was associated with lower flare recurrence through Week 48 than the positive control.
• Time to first recurrence was longer with firsekibart than with the positive control.
• Overall adverse event reporting was similar between groups, and no new safety signals emerged during extended follow-up.

Week 48 follow-up from the multicenter phase 3 firsekibart trial showed a 29.97-percentage-point lower proportion of patients with flare recurrence with firsekibart than with the positive control. Participants were adults with recurrent acute gout, at least 2 flares in the prior year, and contraindication, intolerance, or inadequate response to NSAIDs and/or colchicine. The multicenter randomized double-blind positive-controlled phase 3 trial was conducted at hospitals in China, followed by a 24-week open-label extension. The Week 48 analysis provides longer follow-up on flare control in this trial population.

The double-blind phase ran from Week 0 to Week 24, and the open-label extension continued from Week 24 to Week 48. Of 313 patients in the double-blind phase, 300 entered the extension for continued follow-up. During the extension, firsekibart was administered for acute gout flares as needed, while the blinded comparator had been compound betamethasone. The protocol assessed flare recurrence, number of flares per patient, and time to first recurrence, with health-related quality of life and flare-related pain as exploratory outcomes. A 12-week safety follow-up after the last dose extended observation beyond the treatment period in this selected Chinese hospital population.

By Week 48, flare recurrence occurred in 70 patients (44.9%) in the firsekibart group and 116 patients (74.8%) in the positive control group. The absolute difference in recurrence was -29.97%, with a 95% CI of -40.228% to -18.544%. Median time to first recurrence was not reached with firsekibart, compared with 37 days with positive control. Kaplan-Meier analysis showed a 70% lower recurrence risk with firsekibart (HR 0.30; 95% CI 0.223 to 0.408; stratified log-rank P < 0.0001). The recurrence benefit remained evident across the 48-week observation window.

Safety assessments in the 48-week extension results included adverse events, laboratory tests, and immunogenicity. Treatment-emergent adverse events were reported in 89.7% of patients in the firsekibart group and 89.1% in the positive control group. Safety follow-up continued for 12 weeks after the last dose, extending observation beyond the active treatment period. Investigators reported no new safety signals during extended follow-up, and findings were consistent with the overall study profile.

The authors concluded that firsekibart demonstrated sustained efficacy in reducing gout flare recurrence through 48 weeks, with a consistent and favorable safety profile.