维多珠单抗诱导炎症性肠病缓解的疗效和安全性——以色列真实世界经验

Efficacy and Safety of Vedolizumab for Induction of Remission in Inflammatory Bowel Disease-the Israeli Real-World Experience.

作者信息

Kopylov Uri, Ron Yulia, Avni-Biron Irit, Koslowsky Benjamin, Waterman Matti, Daher Saleh, Ungar Bella, Yanai Henit, Maharshak Nitsan, Ben-Bassat Ofer, Lichtenstein Lev, Bar-Gil Shitrit Ariella, Israeli Eran, Schwartz Doron, Zittan Eran, Eliakim Rami, Chowers Yehuda, Ben-Horin Shomron, Dotan Iris

机构信息

*Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel; †IBD Center, Department of Gastroenterology and Liver Diseases, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; ‡Department of Gastroenterology, Rabin Medical Center, Petach Tikva, Israel; §Digestive Diseases Institute, Shaare Zedek Medical Center, Jerusalem, Israel; ‖Department of Gastroenterology, Rambam Healthcare Campus, Haifa, Israel; ¶Department of Gastroenterology, Hadassah Medical Center, Jerusalem, Israel; **Department of Gastroenterology, Soroka Medical Center, Beer Sheva, Israel; ††Department of Gastroenterology, Haemek Medical Center, Afula, Israel; ‡‡Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; §§Faculty of Medicine, Hebrew University, Jerusalem, Israel; ‖‖Bruce Rappoport Faculty of Medicine, Technion, Haifa, Israel; and ¶¶Faculty of Medicine, Beer Sheba University, Beer Sheba, Israel.

出版信息

Inflamm Bowel Dis. 2017 Mar;23(3):404-408. doi: 10.1097/MIB.0000000000001039.

DOI:10.1097/MIB.0000000000001039

PMID:28178003

Abstract

BACKGROUND

Vedolizumab (VDZ) is an anti-integrin monoclonal antibody effective in ulcerative colitis (UC) and Crohn's disease (CD). The aim of this study was to examine the "real world" efficacy and safety of VDZ in a large national patient cohort.

METHODS

Patients with inflammatory bowel disease treated with VDZ were prospectively followed for 14 weeks. Patients who completed the induction protocol (week 0/2/6/14) or discontinued the treatment before week 14 for adverse events (AEs) or primary nonresponse were included. The primary outcome was induction of clinical remission at week 14; secondary outcomes included clinical response and corticosteroid-free clinical remission.

RESULTS

A total of 204 patients (CD-130, UC-69, inflammatory bowel disease-unclassified-5) from 8 centers in Israel were included. Fifteen (7.4%) of the patients were anti-tumor necrosis factor naive and 46 (35.4%) had a previous surgery. For patients with CD, 69/130 (53.1%) responded to treatment; 45 (34.6%) achieved clinical remission; and 38 (29.2%) achieved corticosteroid-free remission at week 14. Fourteen (10.7%) patients discontinued VDZ before week 14 due to primary nonresponse or AEs. For UC, 32/74 (43.2%) responded to treatment; 20 (28.4%) achieved clinical remission, and 18 (24.3%) achieved corticosteroid-free remission at week 14. Fifteen (20.3%) patients with UC did not complete the induction due to primary nonresponse or AEs. AEs were reported by 29 (14.2%) patients (CD and UC combined), most common being nasopharyngitis and skin eruptions.

CONCLUSIONS

In a large real-world Israeli cohort of anti-tumor necrosis factor-experienced patients with inflammatory bowel disease, VDZ was effective and safe in induction of clinical remission and steroid-free clinical remission.

摘要

背景

维多珠单抗（VDZ）是一种抗整合素单克隆抗体，对溃疡性结肠炎（UC）和克罗恩病（CD）有效。本研究的目的是在一个大型全国患者队列中检验VDZ的“真实世界”疗效和安全性。

方法

对接受VDZ治疗的炎症性肠病患者进行前瞻性随访14周。纳入完成诱导方案（第0/2/6/14周）或在第14周前因不良事件（AE）或原发性无反应而停止治疗的患者。主要结局是第14周时临床缓解的诱导；次要结局包括临床反应和无皮质类固醇临床缓解。

结果

共纳入来自以色列8个中心的204例患者（CD-130例，UC-69例，未分类的炎症性肠病-5例）。15例（7.4%）患者既往未使用过抗肿瘤坏死因子药物，46例（35.4%）患者曾接受过手术。对于CD患者，69/130例（53.1%）对治疗有反应；45例（34.6%）实现临床缓解；38例（29.2%）在第14周实现无皮质类固醇缓解。14例（10.7%）患者在第14周前因原发性无反应或AE而停用VDZ。对于UC患者，32/74例（43.2%）对治疗有反应；20例（28.4%）实现临床缓解，18例（24.3%）在第14周实现无皮质类固醇缓解。15例（20.3%）UC患者因原发性无反应或AE未完成诱导。29例（14.2%）患者（CD和UC合并）报告有AE，最常见的是鼻咽炎和皮疹。