作为炎症性肠病的维持疗法,皮下注射因弗利西马布 (CT-P13 SC):两个随机的第三期试验 (LIBERTY)
Stephen B Hanauer1, Bruce E Sands2, Stefan Schreiber3
1Division of Gastroenterology and Hepatology, Department of Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.
CT-P13皮下注射 (SC) 恩弗利克西马布在克罗恩病中表现出比安慰剂更高的疗效.
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:
- 皮下CT-P13 (SC) 是一种新型配方的infliximab,一种广泛用于炎症性肠道疾病的静脉注射 (IV) 疗法.
- 以前的研究确定了CT-P13IV在克罗恩病 (CD) 和性结肠炎 (UC) 的疗效和安全性.
- 开发一种SC配方在给药和患者方便方面具有潜在的优势.
研究的目的:
- 评估CT-P13 SC作为CD和UC患者的维持疗法的疗效和安全性.
- 为了证明CT-P13 SC在实现临床缓解和内镜反应方面与安慰剂相比的优越性.
主要方法:
- 两项随机的,安慰剂对照的双盲研究 (LIBERTY研究) 在成年患者中进行了中度至重度活跃的CD或UC.
- 获得开放CT-P13IV诱导反应的患者被随机分配到CT-P13SC120 mg或安慰剂每2周一次进行维持治疗.
- 主要终点包括54周临床缓解和内镜反应 (CD) 或临床缓解 (UC).
主要成果:
- 在CD患者中,CT-P13 SC与安慰剂 (P < .0001) 相比,实现了显著更高的临床缓解率 (62.3%对32.1%) 和内镜反应 (51.1%对17.9%).
- 在UC患者中,CT-P13 SC显示显著更高的临床缓解率 (43.2%对20.8%) 与安慰剂相比 (P < .0001).
- CT-P13 SC的耐受性很好,在维护阶段没有发现新的安全问题.
结论:
- CT-P13 SC是一种高效且耐受性良好的维持疗法,适用于中度至严重活性CD或UC的患者,这些患者对CT-P13 IV诱导有反应.
- 皮下配方为这些炎症性肠道疾病的长期治疗提供了可行的替代方案.
- 这些发现支持在临床实践中使用CT-P13 SC来管理CD和UC.
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