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维多利珠单抗在炎症性肠病维持治疗中的疗效和安全性-以色列真实世界经验。

Effectiveness and safety of vedolizumab for maintenance treatment in inflammatory bowel disease-The Israeli real world experience.

机构信息

Department of Gastroenterology, Sheba Medical Center, Affiliated with the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Division of Gastroenterology, Rabin Medical Center, Affiliated with the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Dig Liver Dis. 2019 Jan;51(1):68-74. doi: 10.1016/j.dld.2018.07.040. Epub 2018 Aug 10.

Abstract

INTRODUCTION

Several real-world experience (RWE) studies with vedolizumab (VDZ) for induction of remission in inflammatory bowel diseases (IBD) have been published; however, long-term RWE data is scarce.

AIMS

To describe the effectiveness and safety of VDZ in maintenance treatment of IBD.

METHODS

A multicenter retrospective national study. The primary outcome of was clinical response at week 52; main secondary aims included clinical remission at week 52, rates of secondary loss of response and treatment discontinuation.

RESULTS

We included 193 (133-CD; 60-UC) patients from 9 Israeli IBD centers. At week 52, response was observed in 62/133 (46.7%) CD patients, including 28 (21%) in clinical remission; 71 (53.3%) discontinued treatment or did not respond. For UC, response at week 52 was observed in 27/60 (45%), including 20 (33%) in clinical remission; 33 (55%) discontinued treatment or did not respond. Secondary non-response by week 52 occurred in 19.4% and 23.5% of week 14 responders in CD and UC, respectively. Week 14 response was associated with treatment continuation at week 52: no predictors of secondary loss of response were identified.

SUMMARY

VDZ is safe and effective for maintenance of response and remission in IBD; week 14 response is positively associated with long-term response in both UC and CD.

摘要

简介

已有多项关于 vedolizumab(VDZ)在炎症性肠病(IBD)诱导缓解的真实世界研究(RWE)发表;然而,长期 RWE 数据仍较为缺乏。

目的

描述 VDZ 在 IBD 维持治疗中的有效性和安全性。

方法

一项多中心回顾性全国性研究。主要结局为第 52 周的临床应答;主要次要目标包括第 52 周的临床缓解、继发无应答率和治疗中止率。

结果

我们纳入了来自以色列 9 家 IBD 中心的 193 名(133 名 CD 患者;60 名 UC 患者)患者。在第 52 周,133 名 CD 患者中有 62 名(46.7%)观察到应答,其中 28 名(21%)达到临床缓解;71 名(53.3%)停止治疗或无应答。对于 UC,第 52 周的应答率为 60 名患者中的 27 名(45%),其中 20 名(33%)达到临床缓解;33 名(55%)停止治疗或无应答。第 14 周应答患者中,第 52 周继发无应答分别发生在 CD 和 UC 患者中占 19.4%和 23.5%。第 14 周的应答与第 52 周的治疗持续相关:未确定继发无应答的预测因素。

总结

VDZ 用于维持 IBD 的缓解和缓解是安全有效的;第 14 周的应答与 UC 和 CD 患者的长期应答呈正相关。

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