Efficacy and Safety of Infliximab Retreatment in Crohn's Disease: A Multicentre, Prospective, Observational Cohort (REGAIN) Study from the GETAID.

医学 中止 英夫利昔单抗 内科学 前瞻性队列研究 队列 不利影响 克罗恩病 临床终点 队列研究 观察研究 外科 随机对照试验 疾病
作者
Gilles Boschetti,Maria Nachury,David Laharie,Xavier Roblin,Cyrielle Gilletta,Alexandre Aubourg,Arnaud Bourreille,Camille Zallot,Xavier Hébuterne,Anthony Buisson,Jean-Charles Grimaud,Yoram Bouhnik,Matthieu Allez,Romain Altwegg,Stephanie Viennot,Lucine Vuitton,Franck Carbonnel,Soumen Paul,Kristell Desseaux,Jo Lambert,Laurent Peyrin Biroulet
出处
期刊:The American Journal of Gastroenterology [American College of Gastroenterology]
卷期号:117 (9): 1482-1490 被引量:2
标识
DOI:10.14309/ajg.0000000000001842
摘要

The objective of this study was to describe the efficacy and safety of infliximab (IFX) reintroduction in Crohn's disease (CD) after stopping for loss of response or intolerance.We conducted a prospective multicenter observational cohort study including adult patients with clinically (CD Activity Index >150) and objectively active luminal CD in whom IFX was reintroduced after at least 6 months of discontinuation. The reasons for the initial discontinuation could be a secondary loss of response or IFX intolerance. The reintroduction schedule included 3 IFX infusions at weeks 0, 4, and 8, after a systematic premedication. The primary end point was the efficacy of IFX retreatment at week 26 defined by a CD Activity Index of <150 in the absence of IFX discontinuation or use of corticosteroids, surgery, or other biologic.At week 26, 24 patients (35%) among the 69 analyzed reached the primary end point. No significant difference was observed between rates of clinical remission at week 26 in patients with prior LOR (n = 48) and those with IFX intolerance (n = 21) (35% and 33%, P = 0.87, respectively). Thirty-two acute infusion reactions were recorded in 27 patients, leading to withdrawal of IFX in 20 patients. No pharmacokinetic characteristic at baseline but detection of positive anti-drug antibodies at week 4 was predictive of IFX failure or infusion reaction at week 26.In this first prospective cohort study, IFX retreatment was safe and effective in one-third of the patients with CD, regardless the reason of prior discontinuation. Early detection of anti-drug antibodies can predict subsequent IFX reintroduction failure and infusion reactions.
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