在5 - 氨基酸失效后,对中度活跃的性结肠炎患者进行长期奥萨尼莫德治疗
Andres Yarur1, Peter Irving2, Britta Siegmund3
1Cedars-Sinai Medical Center, Los Angeles, CA 90048, United States.
Inflammatory bowel diseases
|September 26, 2025
概括
奥萨尼莫德在治疗中度性性结肠炎 (UC) 患者的治疗中显示出显著的疗效和安全性,这些患者未能接受5 - 氨基酸治疗. 在先进治疗前的UC患者中,治疗显示出长达五年的持久有效性.
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:
- 评估了ozanimod在中度性结肠炎 (UC) 患者的疗效和安全性,该患者在5 - 氨基酸 (5-ASA) 失败后.
- 专注于先进治疗 (AT) 无知的患者,评估真北试验及其开放式扩展 (OLE) 的结果.
研究的目的:
- 评估ozanimod的疗效和安全性在以前未接受AT治疗的中度UC患者中,这些患者之前未能接受5-ASA治疗.
- 为了评估ozanimod在长时间治疗期间的治疗效果的持久性.
主要方法:
- 一个随机的,52周的,第三期试验 (True North) 与可选的开放标签扩展 (OLE).
- 在试验和OLE中评估有效性;在OLE第190周内监测安全性.
- 包括AT-naive患者中度UC (梅奥内镜子子评分≥2,修改的梅奥评分4-6),直肠出血子评分≥1).
主要成果:
- 与安慰剂相比,10周和52周的Ozanimod显著提高了AT-naive中度UC患者的疗效率,无论之前是否使用免疫调节剂/皮质类固醇.
- 在第二周使用ozanimod的AT-naive患者中 (50.5%) 与整体AT-naive患者群体 (38.7%) 相比,观察到更高的症状反应率.
- 在最初响应者中,有效性在OLE周190保持,在非响应者中,在第5周实现了显著的症状响应.
结论:
- 奥扎尼莫德是一种安全,有效和持久的治疗选择,适合那些传统的5-ASA疗法失败的中度UC的AT-naive患者.
- 这项研究支持ozanimod在治疗中度UC患者群体中的长期效用.
- 在延长治疗期间,没有发现新的安全信号.
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