Efficacy and Safety of Firsekibart in Gout Patients with Different Estimated Glomerular Filtration Rates

Abstract

To compare the efficacy and safety of Firsekibart versus compound betamethasone in gout patients with different estimated glomerular filtration rate (eGFR) levels. Methods: Patients were randomized, double blinded and separated into two equal groups to receive a single dose of Firsekibart (200 mg) or compound betamethasone (7 mg). Patients were divided into three subgroups according to baseline eGFR: ≥ 90, 60–89, and 30–59 mL/min/1.73 m² to evaluate 72-hour pain relief, 12/24-week recurrence rate, renal function changes, and safety events. Results: Of 311 patients in full analysis set (FAS), 113 (36.3%) had baseline eGFR 60–89 mL/min/1.73 m², and 42 (13.5%) had baseline eGFR 30–59 mL/min/1.73 m². Similar reduction in visual analogue scale (VAS) scores at 72-hour was observed in each eGFR subgroup between Firsekibart and compound betamethasone group (p > 0.05). Compared with compound betamethasone, Firsekibart reduced the risk of recurrence at 12/24 weeks in patients with different eGFR subgroups (all p < 0.0001). In safety evaluation, no obvious changes of creatinine and eGFR were observed in each subgroup during 24-week follow up. Treatment emergent adverse events (TEAEs) incidence was comparable in each eGFR subgroup analysis. In total, 1 (0.6%) patient experienced emergent serious adverse events (TESAE) and 0 treatment-related adverse events (TRSAE) was reported in the Firsekibart group compared to 6 (3.8%) and 3 (1.9%) in the compound betamethasone group, respectively. Conclusion: Overall, Firsekibart demonstrated non-inferior short-term pain relief while offering better prevention of new flares, with a lower incidence of serious adverse events compared to compound betamethasone, and results were consistent across eGFR subgroups. Both Firsekibart and compound betamethasone showed little effect on renal function.