粘膜愈合终点与性结肠炎的长期临床和患者报告结果的相关性
Gareth Parkes1, Ryan C Ungaro2, Silvio Danese3
1Dept of Gastroenterology, Royal London Hospital, Barts Health NHS Trust, London, UK. gareth.parkes@nhs.net.
在用upadacitinib治疗的性结肠炎患者中实现组织学内性粘膜缓解 (HEMR) 是临床相关的. 与组织内镜粘膜改善 (HEMI) 相比,HEMR与更好的长期临床和患者报告结果有关.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验 临床试验
- 炎症性肠道疾病是什么
背景情况:
- 性结肠炎 (UC) 是一种慢性炎症性肠病.
- 乌帕达西尼布是一种口服的Janus激酶 (JAK) 抑制剂,用于UC治疗.
- 组织学愈合终点,包括HEMI和HEMR,在UC试验中越来越多地被认可.
研究的目的:
- 评估实现组织学内镜粘膜改善 (HEMI) 和组织学内镜粘膜缓解 (HEMR) 的临床相关性.
- 在UC维护试验中评估HEMI/HEMR与长期临床和患者报告结果之间的关联.
主要方法:
- 在中度至重度活跃的UC患者中,对upadacitinib维护疗法的3期试验.
- 患者在诱导后接受了52周的维持治疗.
- 截面和预测分析与第8/16周的HEMI/HEMR与第52周的结果相关联.
主要成果:
- 在52周,HEMR的实现与临床缓解 (aOR=3.6) 和内镜缓解 (aOR=3.9) 的几率显著增加.
- 没有HEMR的HEMI也改善了临床 (aOR=3.2) 和内镜缓解 (aOR=2.4) 的几率.
- 在52周实现HEMR的患者中没有观察到住院治疗或手术.
结论:
- 获得HEMR或HEMI对于接受上巴西提尼布维持治疗的UC患者来说具有临床意义.
- HEMR与改善长期临床和患者报告结果的可能性更大.
- 在UC管理中,HEMR可能代表一个更严格和有益的治疗目标.
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