Population pharmacokinetics and exposure–response modelling of firsekibart (GenSci048) in patients with acute gout flare: Implications for fixed‐dose optimization

BACKGROUND AND OBJECTIVES: Firsekibart (formerly GenSci048 or genakumab) is a humanized anti-IL-1β monoclonal antibody developed for acute gouty flares in patients unsuitable for standard therapies. This study characterized its population pharmacokinetics (PopPK), assessing covariate effects, and established exposure-response (E-R) relationships to guide dosing. METHODS: , defined as achieving ≥50% reduction in Visual Analog Scale [VAS] scores from baseline measured at 72 h) and safety (dyslipidaemia/hepatic dysfunction/infectious and invasive diseases) using logistic regression. RESULTS: . Firsekibart also markedly reduced flare recurrence over 12 weeks compared with the control group. CONCLUSION: Firsekibart demonstrated predictable pharmacokinetics, a favourable safety profile, and robust efficacy coverage at the 200-mg fixed dose. These findings support fixed-dosing for patients with acute gout flares who are intolerant of, unsuitable for, or inadequately responsive to standard-of-care therapies.