针对性结肠炎使用菲尔戈提尼布的综合安全性分析:SELECTION和SELECTIONLTE的结果
Stefan Schreiber1, Gerhard Rogler2, Mamoru Watanabe3
1Department Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany.
Alimentary pharmacology & therapeutics
|September 18, 2023
概括
菲尔戈提尼布 (FIL200) 在性结肠炎 (UC) 患者中表现出耐受性良好的安全性. 来自SELECTION研究的综合数据显示没有意外的安全信号,支持其在UC管理中的使用.
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:
- 菲尔戈提尼布200毫克 (FIL200) 是一种已批准的治疗方法,用于中度至重度活性的性结肠炎 (UC) 的成年人.
- 性结肠炎是一种慢性炎症性肠病,需要有效和安全的治疗选择.
研究的目的:
- 报告2b/3期SELECTION研究及其正在进行的长期扩展研究的综合安全数据.
- 评估filgotinib在中度至重度活跃UC的成年患者中的安全性和耐受性.
主要方法:
- 来自SELECTION (NCT02914522) 和SELECTIONLTE (NCT02914535) 研究的综合安全数据分析.
- 患有UC的成年患者接受了FIL200,菲尔戈提尼布100毫克 (FIL100) 或安慰剂.
- 报告了治疗出现的不良事件的暴露调整发病率 (EAIR).
主要成果:
- 临时分析包括1348名患者和3326.2名患者暴露年.
- 严重感染,血栓塞栓事件和MACE的EAIR在治疗组中均较低.
- 疹杆菌EAIR在FIL200的数量上更高;在生物经验丰富的患者中,感染发病率更高.
结论:
- 在中度至重度活跃UC的患者中,FIL200和FIL100的耐受性很好.
- 没有发现任何意外的安全信号,无论年龄或先前的生物暴露.
- 菲尔戈提尼布代表了性结肠炎的安全治疗选择.
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