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Remo Panaccione1, Miguel Regueiro2, Scott D Lee3
1Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada.
在克罗恩氏病患者的52周内,upadacitinib显著改善了临床缓解和内镜反应. 该药物表现出良好的安全性,与之前的研究结果一致,没有发现新的安全问题.
科学领域:
- 胃肠病学 胃肠病学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 克罗恩氏病是一种慢性炎症性肠病.
- 乌帕达西提尼布是一种口服的Janus激酶抑制剂.
- 之前的试验 (U-EXCEL,U-EXCEED) 在克罗恩病中显示出有效性和安全性.
研究的目的:
- 在更广泛的克罗恩病患者群体中评估upadacitinib维持治疗的疗效和安全性.
- 为介绍U-ENDURE试验 (N=673) 的总体结果.
主要方法:
- 随机对照试验 (U-ENDURE) 涉及673名患者.
- 响应了12周的阿帕达西提尼布诱导的患者随机分配给阿帕达西提尼布15毫克,30毫克或安慰剂,维持52周.
- 共同初级终点:克罗恩病活动指数 (CDAI) 临床缓解和52周内镜反应.
主要成果:
- 在52周使用上巴迪西尼布15毫克 (36.2%) 和30毫克 (51.5%) 和安慰剂 (15.2%) 时,CDAI临床缓解率较高.
- 与安慰剂 (7.2%) 相比,对upadacitinib 15 mg (27.3%) 和30 mg (40.7%) 的内镜反应率显著更高.
- 对治疗出现的不良事件的暴露调整事件率数量较低,与安慰剂相比,用upadacitinib增加了疹病毒感染.
结论:
- 在克罗恩病维持过程中,upadacitinib在临床和内镜终点方面表现出比安慰剂更高的疗效.
- 乌帕达西提尼布的安全性概况与之前的研究一致,没有显示新的安全信号.
- 乌帕达西提尼布是克罗恩病的有效口服治疗选择.
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