Firsekibart in Reducing High-Sensitivity C-reactive Protein Levels of Gout

© 2025 by the Authors. Licensee Whioce Publishing, Singapore. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution -Noncommercial 4.0 International License (CC BY-NC 4.0) ( https://creativecommons.org/licenses/by-nc/4.0/ )

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Abstract

Background: Gout remains a challenging condition with rising global prevalence. The IL-1β drives disease pathogenesis, and high-sensitivity C-reactive protein (hsCRP) correlates with gout activity. Firsekibart, a novel fully human anti-IL-1β monoclonal antibody, has proven its efficacy on gout, while the data on reducing hsCRP remains limited. Methods: This multicenter, randomized, double-blind phase III trial compared Firsekibart (200 mg subcutaneous) with compound betamethasone (7 mg intramuscular) in acute gout patients who were contraindicated to, intolerant of, or unresponsive to NSAIDs and/or colchicine. Serum hsCRP levels were measured at 72 hours, 7 days post-dose, and 4 weeks post-dose. Results: Both groups achieved comparable hsCRP reduction at 72 hours (Firsekibart: −14.68 mg/L [95% CI: −15.75, −13.61] vs. compound betamethasone: −14.58 mg/L [−15.66, −13.50]; P=0.898). Firsekibart demonstrated better sustained suppression at 7 days post-dose (−18.63 vs. −9.28 mg/L, P<0.001) and 4 weeks (−18.37 vs. −12.65 mg/L, P<0.0001). Conclusion: Compared with compound betamethasone, Firsekibart showed a longer-lasting anti-inflammatory effect on gout patients. This result may provide significant clinical value in the management of gout and its associated complications.

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