De Vos Martine, Dhooghe Barbara, Vermeire Severine, Louis Edouard, Mana Fazia, Elewaut Ann, Bossuyt Peter, Baert Filip, Reenaers Catherine, Van Gossum Marc, Macken Elisabeth, Ferrante Marc, Hindryckx Pieter, Dewit Olivier, Holvoet Tom, Franchimont Denis
Department of Gastroenterology and Hepatology, University Hospital Ghent, Belgium.
Departments of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Belgium.
United European Gastroenterol J. 2018 Apr;6(3):439-445. doi: 10.1177/2050640617722310. Epub 2017 Jul 26.
Vedolizumab is a recently available monoclonal antibody targeting α4β7 integrin for the treatment of ulcerative colitis (UC) and Crohn's disease (CD).
The objective of this article is to evaluate the efficacy of vedolizumab induction therapy in anti-TNF-refractory/intolerant UC and CD patients in real life.
A cohort of 149 moderately to severely active UC and CD patients who failed or showed intolerance to at least two TNF antagonists participated in a medical need program and received vedolizumab in 37 Belgian centers (April-September 2015). Rates of clinical response and remission were retrospectively evaluated at Week 10 for UC and Week 14 for CD using the physician's global assessment (PGA), Mayo score and Harvey Bradshaw index (HBI) or Crohn's disease activity score (CDAI) scores.
Eighty-four patients (29 UC, 55 CD) had sufficient data for analysis. For UC patients, clinical response was observed in 76% based on PGA and 59% based on the Mayo score. The corresponding percentages for CD patients were 80% for PGA and 65% for HBI/CDAI. Clinical remission rates were 10% and 40% for UC and CD, respectively. Steroid-free remission was observed in respectively 10% and 35%. Globally, corticosteroids were stopped in 14 out of 48 patients (29%). No new safety signals were reported.
Up to 70% TNF-refractory/intolerant UC and CD patients achieved a clinical response after 10 to 14 weeks of vedolizumab treatment in this real-life cohort.
维多珠单抗是一种最近可用的靶向α4β7整合素的单克隆抗体，用于治疗溃疡性结肠炎（UC）和克罗恩病（CD）。
本文旨在评估维多珠单抗诱导疗法在现实生活中对抗肿瘤坏死因子（TNF）难治性/不耐受的UC和CD患者的疗效。
149例中度至重度活动性UC和CD患者，这些患者对至少两种TNF拮抗剂治疗失败或不耐受，他们参与了一项医疗需求项目，并于2015年4月至9月在比利时的37个中心接受了维多珠单抗治疗。使用医生整体评估（PGA）、梅奥评分、哈维·布拉德肖指数（HBI）或克罗恩病活动指数（CDAI）评分，在第10周对UC患者和第14周对CD患者的临床缓解率进行回顾性评估。
84例患者（29例UC，55例CD）有足够的数据进行分析。对于UC患者，基于PGA的临床缓解率为76%，基于梅奥评分的为59%。CD患者的相应百分比分别为PGA的80%和HBI/CDAI的65%。UC和CD的临床缓解率分别为10%和40%。无类固醇缓解率分别为10%和35%。总体而言，48例患者中有14例（29%）停用了皮质类固醇。未报告新的安全信号。
在这个现实生活队列中，高达70%的TNF难治性/不耐受的UC和CD患者在接受维多珠单抗治疗10至14周后实现了临床缓解。
