Demonstrates effective dosing of firsekibart in acute gout flares, suggesting fixed-dose optimization for better outcomes.
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. 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.
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Wang et al. (2026) studied this question.
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