ENTERPRET:一种随机对照试验,用于在早期没有反应的性结肠炎患者中优化vedolizumab的剂量
Vipul Jairath1, Andres Yarur2, Mark T Osterman3
1Division of Gastroenterology, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
概括
对于早期不反应和高药物清除的性结肠炎患者,可能不需要优化vedolizumab的剂量. 继续治疗的结果显示,无论患者服用了多少维多利祖马布剂量,都会有好处.
科学领域:
- 胃肠病学 胃肠病学
- 临床药理学 临床药理学
- 免疫抑制疗法 免疫抑制疗法
背景情况:
- 性结肠炎 (UC) 患者可能因药物暴露低而无法对生物药物产生反应.
- 维多利祖马布是一种用于治疗UC的生物疗法.
- 在UC中早期没有对vedolizumab的反应可能与高药物清除有关.
研究的目的:
- 为了评估vedolizumab剂量优化在UC患者早期无反应的疗效.
- 评估增加vedolizumab剂量是否能改善高药物清除率患者的治疗结果.
- 确定剂量优化对UC内镜改善的影响.
主要方法:
- 第四阶段,开放标签,随机对照试验 (ENTERPRET,NCT03029143).
- 患有中度至重度UC和高vedolizumab清除 (<50μg/mL在第5周) 的患者在第6周随机分配.
- 干预组:标准vedolizumab剂量 (300 mg Q8W) 与剂量优化的vedolizumab (600 mg Q4W或600 mg Q8W) 相比.
- 主要终点:第30周内镜改善.
主要成果:
- 在第6周没有反应的108名患者被随机分配到标准 (n=53) 或优化 (n=55) vedolizumab.
- 30周内镜改善:18.9% (标准) 与14.5% (优化) 相比.
- 30周临床缓解:9.4% (标准) 与9.1% (优化) 相比.
- 在两组中,安全事件的发生率相似.
结论:
- 对于早期无反应和高药物清除的UC患者,可能不需要对vedolizumab剂量进行优化.
- 很大一部分患者受益于持续的vedolizumab治疗,无论剂量调整如何.
- 进一步的研究可能会探索非响应性UC患者的替代策略.
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