Scholarlink

Introduction <p>Patients with recurrent acute gout flares who are unable to use nonsteroidal anti-inflammatory drugs (NSAIDs) or colchicine have limited alternatives and remain at high risk of flare recurrence. Firsekibart is a fully human monoclonal antibody targeting interleukin-1βeta (IL-1β) The objective of this study is to evaluate the longer-term efficacy and safety of firsekibart through 48&#xa0;weeks in patients with acute gout unsuitable for standard anti-inflammatory therapy.</p> Methods <p>This was a multicenter, randomized, double-blind, positive-controlled phase 3 study of firsekibart with compound betamethasone. Followed by a 24-week open-label extension (OLE), conducted at hospitals in China. The double-blind phase was conducted from Week&#xa0;0 to Week&#xa0;24, followed by an OLE through Week&#xa0;48 and a 12-week safety follow-up period after the last dose. Adults with ≥ 2 acute gout flares in the past year and a contraindication, intolerance, or inadequate response to NSAIDs and/or colchicine were enrolled. Patients completing the double-blind phase entered the OLE, during which firsekibart was administered for acute gout flares as needed. Efficacy included proportion of patients experiencing ≥ 1 gout flare recurrence, number of flares per patient, and time to first recurrence through Week 48, as well as rescue medication use during the OLE. Exploratory outcomes included health-related quality of life and flare-related pain. Safety included adverse events (AEs), laboratory tests, and immunogenicity.</p> Results <p>Of 313 patients (double-blind phase), 300 entered the OLE. By week 48, gout flare recurrence occurred in 70 patients (44.9%) in the firsekibart group compared with 116 (74.8%) in the positive control group (difference − 29.97%; 95% CI − 40.228% to − 18.544%). Kaplan–Meier analysis showed that the median time to first recurrence was not reached with firsekibart versus 37&#xa0;days with positive control, indicating a 70% [hazard ratio (HR) 0.30; 95% confidence interval (CI) 0.223, 0.408; stratified log rank <i>P</i> &lt; 0.0001] lower recurrence risk. Firsekibart maintained efficacy through Week 48. Treatment-emergent adverse events were reported in 89.7% of patients in the firsekibart group and 89.1% in the positive control group, with no new safety signals identified during extended follow-up.</p> Conclusion <p>In this open-label extension study, firsekibart demonstrated sustained efficacy in reducing gout flare recurrence through 48&#xa0;weeks, with a consistent and favorable safety profile, and no new safety signals identified during extended follow-up.</p> <p><b>Trial Registration:</b> NCT05983445.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Efficacy and Safety of Firsekibart in Patients with Acute Gout Unsuitable for Standard Therapy: 48-Week Results from an Open-Label Extension of a Randomized Phase 3 Trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月19日

查看全文
  • Zaihua Zhu,
  • Yu Xue,
  • Tianshu Chu,
  • Jiankang Hu,
  • Wei Gou,
  • Ning Zhang,
  • Juan Li,
  • Jing Yu,
  • Rongping Li,
  • Rongbin Li,
  • Long Qian,
  • Xinwang Duan,
  • Lihua Duan,
  • Qian Xu,
  • Fei Gu,
  • Yuling Lian,
  • Xu Zhang,
  • Hejian Zou

摘要

Introduction

Patients with recurrent acute gout flares who are unable to use nonsteroidal anti-inflammatory drugs (NSAIDs) or colchicine have limited alternatives and remain at high risk of flare recurrence. Firsekibart is a fully human monoclonal antibody targeting interleukin-1βeta (IL-1β) The objective of this study is to evaluate the longer-term efficacy and safety of firsekibart through 48 weeks in patients with acute gout unsuitable for standard anti-inflammatory therapy.

Methods

This was a multicenter, randomized, double-blind, positive-controlled phase 3 study of firsekibart with compound betamethasone. Followed by a 24-week open-label extension (OLE), conducted at hospitals in China. The double-blind phase was conducted from Week 0 to Week 24, followed by an OLE through Week 48 and a 12-week safety follow-up period after the last dose. Adults with ≥ 2 acute gout flares in the past year and a contraindication, intolerance, or inadequate response to NSAIDs and/or colchicine were enrolled. Patients completing the double-blind phase entered the OLE, during which firsekibart was administered for acute gout flares as needed. Efficacy included proportion of patients experiencing ≥ 1 gout flare recurrence, number of flares per patient, and time to first recurrence through Week 48, as well as rescue medication use during the OLE. Exploratory outcomes included health-related quality of life and flare-related pain. Safety included adverse events (AEs), laboratory tests, and immunogenicity.

Results

Of 313 patients (double-blind phase), 300 entered the OLE. By week 48, gout flare recurrence occurred in 70 patients (44.9%) in the firsekibart group compared with 116 (74.8%) in the positive control group (difference − 29.97%; 95% CI − 40.228% to − 18.544%). Kaplan–Meier analysis showed that the median time to first recurrence was not reached with firsekibart versus 37 days with positive control, indicating a 70% [hazard ratio (HR) 0.30; 95% confidence interval (CI) 0.223, 0.408; stratified log rank P < 0.0001] lower recurrence risk. Firsekibart maintained efficacy through Week 48. Treatment-emergent adverse events were reported in 89.7% of patients in the firsekibart group and 89.1% in the positive control group, with no new safety signals identified during extended follow-up.

Conclusion

In this open-label extension study, firsekibart demonstrated sustained efficacy in reducing gout flare recurrence through 48 weeks, with a consistent and favorable safety profile, and no new safety signals identified during extended follow-up.

Trial Registration: NCT05983445.