ArticleBritish journal of clinical pharmacology2026
Population pharmacokinetics and exposure-response modelling of firsekibart (GenSci048) in patients with acute gout flare: Implications for fixed-dose optimization.
Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Population pharmacokinetics and exposure-response modelling of firsekibart (GenSci048) in patients with acute gout flare: Implications for fixed-dose optimization.British journal of clinical pharmacology · 2026Article
- Clinical response to firsekibart in a 73-year-old patient with tophaceous gout complicated by prostate cancer and chronic kidney disease: a case report.Translational andrology and urology · 2026Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesFirsekibart (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.
methodsData from four clinical trials involving 296 subjects (2287 concentrations) were pooled to develop a PopPK model using NONMEM with stepwise covariate screening. A one-compartment model with sequential zero- and first-order absorption was utilized. E-R analyses were conducted to assess efficacy (dVAS
resultsBody weight significantly affected clearance and distribution volume. Hepatic or renal impairment caused exposure differences of less than 27%. No exposure-dependent safety trends were identified across the evaluated exposure range. Although exposure-response trends were observed across the broader dose range, the gradient within the exposure range achieved by 195-200 mg was shallow, consistent with a plateau. Simulations indicated that at the 200-mg dose, more than 95% of patients attained exposures associated with at least 85% probability of achieving dVAS
conclusionFirsekibart 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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