克罗恩病的维护因弗利西马布:ACCENT I随机试验
Stephen B Hanauer1, Brian G Feagan, Gary R Lichtenstein
1Department of Gastroenterology and Nutrition, University of Chicago Medical Center, Chicago, IL 60637, USA. shanauer@medicien.bsd.uchicago.edu
维持性因弗利克西马布治疗显著改善了克罗恩病患者的缓解率,并延长了反应时间. 每8周一次的持续治疗比安慰剂更有效于持续的临床缓解.
科学领域:
- 胃肠病学 胃肠病学
- 免疫学 免疫学 免疫学
- 临床药理学 临床药理学
背景情况:
- 克罗恩氏病是一种慢性炎症性肠病.
- 恩弗利西玛布是一种用于克罗恩病的生物疗法.
- 评估最佳的INFLIXIMAB剂量策略对于患者管理至关重要.
研究的目的:
- 评估在最初对治疗有反应的活跃克罗恩病患者中维持因弗利克西马布治疗的疗效.
- 为了与安慰剂比较不同的INFLIXIMAB再输液计划.
- 为了确定维持治疗对临床缓解和响应丧失的时间的影响.
主要方法:
- 一项随机对照试验,涉及573名活跃克罗恩病患者 (CDAI评分≥220).
- 患者接受了Infliximab初始输注,随后随机分配到安慰剂,标准剂量或升级剂量的Infliximab维持疗法.
- 同主终点包括30周缓解和54周失去反应的时间,根据治疗意图进行分析.
主要成果:
- 58%的患者对最初的INFLIXIMAB输液有反应.
- 与安慰剂 (21%) 相比,在维持因弗利克西马布组 (39-45%) 观察到30周内显著更高的缓解率.
- 与安慰剂 (19周) 相比,维持因弗利克西马布显著延长了反应丧失的时间 (中位数>54周).
结论:
- 每8周一次的维持性因弗利西马布治疗有效地维持了对初始治疗有反应的克罗恩病患者的临床缓解.
- 持续治疗infliximab会导致更长时间的反应,并支持停用皮质类固醇.
- 维护用因弗力西马布的安全性概况与先前的研究一致,各组严重感染率相似.
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