达尔瓦德斯特罗塞尔在克罗恩氏病患者中与复杂的外周囊:ADMIRE CD II 第三阶段随机试验
Jean-Frédéric Colombel1, Damian Garcia Olmo2, Szu-Ta Chen3
1The Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Gastroenterology
|March 6, 2026
概括
与安慰剂相比,Darvadstrocel在克罗恩氏病患者中并没有显著改善复杂周囊的综合缓解率. 这项研究没有发现Darvadstrocel治疗带来了新的安全问题.
科学领域:
- 胃肠病学 胃肠病学
- 再生医学是一种再生医学.
- 临床试验 临床试验
背景情况:
- 在此之前,ADMIRE CD试验显示了darvadstrocel对复杂的近囊的疗效.
- 这项研究将调查扩展到北美,欧洲和以色列的更大,更多样化的患者群体.
研究的目的:
- 为了评估darvadstrocel在患有克罗恩氏病和复杂周围囊患者的扩大群体中的疗效和安全性.
- 评估第24周的综合缓解率作为主要终点.
主要方法:
- 第三阶段,双盲,随机,安慰剂对照试验 (ADMIRE CD II).
- 患有克罗恩病和复杂的近囊的成年人接受了darvadstrocel或安慰剂的治疗.
- 随机化是1:1的,主要终点是24周的联合缓解.
主要成果:
- 在24周的联合缓解达到了darvadstrocel组的48.8%,而安慰剂组的46.3% (P = .571).
- 在关键的二次终点,包括临床缓解,没有观察到统计学意义上的差异.
- 副作用是罕见的,在两个治疗臂中发生的比例相似.
结论:
- ADMIRE CD II没有达到其主要终点,在联合缓解方面没有显示达尔瓦德斯特罗塞尔和安慰剂之间的显著差异.
- 达尔瓦德斯特罗塞尔证明了与安慰剂相比的安全性,没有发现新的安全信号.
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