在活跃牛皮关节炎 (DISCOVER-2) 的生物原始患者中使用Guselkumab:双盲,随机,安慰剂控制的第三阶段试验
Philip J Mease1, Proton Rahman2, Alice B Gottlieb3
1Department of Rheumatology, Swedish Medical Center, Providence St Joseph Health and University of Washington, Seattle, WA, USA.
Lancet (London, England)
|March 18, 2020
概括
在没有生物治疗的患者中,Guselkumab有效治疗了牛皮关节炎. 在 DISCOVER-2 试验中,这种插白素-23 (IL-23) 抑制剂显示出显著的疗效和良好的安全性.
科学领域:
- 免疫学
- 关节病学
- 皮肤病学
背景情况:
- 在牛皮关节炎 (PsA) 的发展过程中,介素-23 (IL-23) / T-helper 17细胞通路至关重要.
- 作为一种选择性IL-23p19亚单元抑制剂,Guselkumab在第二阶段的PsA研究中显示出有前途.
- DISCOVER-2 是一项评估古塞尔库马布在生物原始的PsA患者中的第三阶段试验.
研究的目的:
- 评估之前没有接受过生物治疗的活跃牛皮关节炎患者的guselkumab的疗效和安全性.
- 为了比较每4周给药的guselkumab与每8周给药的安慰剂.
- 确定在24周内达到ACR20反应的患者比例.
主要方法:
- 在13个国家进行的第三阶段双盲,安慰剂对照研究.
- 741名患有活跃牛皮关节炎的生物原始患者被随机 (1:1:1) 分给guselkumab (100 mg每4周或8周) 或安慰剂.
- 主要终点:美国风湿病学学院在24周的反应有20%的改善 (ACR20).
主要成果:
- 与安慰剂相比,每4周 (64%) 和每8周 (64%) 的ACR20反应率在第24周显著增加 (p< 0. 0001).
- 两种古塞尔库马布剂量方案的百分比差异与安慰剂为31%.
- 严重的不良事件在不同组中很少且可比;直到第24周没有死亡.
结论:
- 在未有生物治疗的患者中,Guselkumab在改善活跃牛皮关节炎的迹象和症状方面表现出显著的有效性.
- 这种药物具有可接受的益处风险概况,支持其在该人群中的使用.
- 选择性IL-23抑制是一种可行的治疗策略.
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