在中度至重度活跃性结肠炎 (QUASAR) 患者中的古塞尔库马布:双盲,随机,安慰剂控制的第三阶段诱导和维持研究
David T Rubin1, Jessica R Allegretti2, Julián Panés3
1University of Chicago Medicine Inflammatory Bowel Disease Centre, Chicago, IL, USA.
Lancet (London, England)
|December 20, 2024
概括
在中度至重度活跃性结肠炎的成年人中,guselkumab有效诱导并维持了缓解. 在第三阶段试验中,这种互白素-23抑制剂表现出良好的安全性,为患者提供了新的治疗选择.
科学领域:
- 胃肠病学
- 免疫学
- 药理学
背景情况:
- 性结肠炎 (UC) 是一种慢性炎症性肠病.
- 互白素-23 (IL-23) 是UC发病的一个关键细胞因子.
- 抑制IL-23已成为UC的有前途的治疗策略.
研究的目的:
- 评估IL-23p19亚单元抑制剂guselkumab在中度至重度活跃UC患者中诱导和维持缓解的疗效和安全性.
- 在第三阶段临床试验中,与安慰剂相比,评估guselkumab的性能.
主要方法:
- 进行了两项随机,双盲,安慰剂控制的第三期研究 (QUASAR诱导和维持).
- 包括中度至重度UC活跃且对先前治疗反应不足的成年人.
- 患者接受了静脉注射的guselkumab或安慰剂作为诱导剂,其次是皮下注射的guselkumab或安慰剂作为维持剂.
主要成果:
- 与安慰剂相比,Guselkumab在第12周显著增加了临床缓解率 (23%与8%,p< 0. 0001).
- 在维持阶段,古塞尔库马布两种剂量方案的临床缓解率显著高于安慰剂 (19%,p< 0. 0001).
- 古塞尔库马布的安全概况是有利的,与已知的概况一致,没有发现新的安全问题.
结论:
- 在中度至重度活跃的性结肠炎患者中,Guselkumab在实现和维持临床缓解方面表现出显著的有效性.
- 在这种患者群体中,Guselkumab为诱导和维持治疗提供了安全有效的治疗选择.
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