Real-world effectiveness and safety of firsekibart versus compound betamethasone in frequent gout flares: a multicenter retrospective study

Acute gout flares cause severe pain and functional impairment, with limited options for patients intolerant to conventional therapies. Firsekibart, a novel anti-IL-1β monoclonal antibody, was approved in China in July 2025, but real-world evidence remains scarce.

This multicenter retrospective study enrolled 50 patients with acute gout flares (25 firsekibart 200 mg, 25 compound betamethasone 7 mg). Co-primary endpoints were VAS pain change at 48 h and time to first flare within 12 weeks. Secondary endpoints included pain at other timepoints, CRP change, flare frequency, and time to first flare within 24 weeks. Inverse probability weighting balanced baseline covariates, with weighted log-rank as primary analysis and Firth's penalized Cox regression for sensitivity analysis.

Baseline characteristics were balanced. Pain relief was comparable between groups (P > 0.05). No firsekibart patients flared within 12 weeks vs. 11 (44.0%) on betamethasone. Weighted log-rank showed significantly lower flare risk with firsekibart (p < 0.001). Firth's penalized Cox confirmed a 97% risk reduction at 12 weeks (HR: 0.03; 95% CI: 0.01–0.59) and 88% at 24 weeks (HR: 0.12; 95% CI: 0.02–0.78). Median CRP decreased significantly with firsekibart (from 14.20 to 3.85 mg/L, P < 0.0001). Both treatments had acceptable safety profiles.

In this real-world study of patients with frequent flares, firsekibart showed comparable analgesic efficacy to compound betamethasone and was associated with superior sustained flare prevention and acceptable safety. These findings suggest firsekibart may be a potential treatment option for patients with limited alternatives, though larger studies are warranted.