生物开关时间和性结肠炎/克罗恩病患者感染风险:一项回顾性研究
Annie J Kruger1, Flavio Dormont2, Nicolas Capit3
1Immunology and Inflammation, Sanofi, Cambridge, Massachusetts.
概括
在性结肠炎和克罗恩病中,重叠的生物开关是常见的. 与非重叠开关相比,这些开关不会增加严重感染的风险,这表明改善治疗管理的潜力.
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:
- 有限的现实世界数据存在于性结肠炎 (UC) 和克罗恩病 (CD) 的生物治疗切换时间.
- 了解与不同生物切换策略相关的感染风险对于患者安全和有效的疾病管理至关重要.
研究的目的:
- 为了研究UC/CD患者生物治疗开关的现实世界模式.
- 在重叠开关 (OS) 和非重叠开关 (NOS) 之间比较任何感染和严重感染的风险.
主要方法:
- 使用非识别索赔数据 (2017-2022) 的回顾性观察性研究.
- 确定UC/CD患者开始生物治疗和分类切换时间 (OS: ≤5半衰期,NOS: >5半衰期).
- 使用加权的Cox比例危险模型来估计感染风险的调整危险比率 (aHR).
主要成果:
- 在11,992名患者中,1293名 (10.8%) 转换了生物药物;64.2%是OS.
- 任何感染的发病率在OS和NOS组之间都是可比的.
- 在OS和NOS之间,任何感染 (aHR=1.40,P=.17) 或严重感染 (aHR=0.95,P=.93) 的调整危险比率没有显著差异.
结论:
- 在UC/CD临床实践中,重叠的生物开关是常见的.
- 与非重叠开关相比,重叠开关与严重感染的风险增加无关.
- 缩短的洗期可能为治疗管理和临床试验招聘提供利益,安全风险最小.
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