Efficacy and Safety of Infliximab Retreatment in Crohn's Disease: A Multicentre, Prospective, Observational Cohort (REGAIN) Study from the GETAID - Université de Lorraine Access content directly
Journal Articles The American Journal of Gastroenterology Year : 2022

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

Gilles Boschetti
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David Laharie
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Xavier Roblin
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Cyrielle Gilletta
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Alexandre Aubourg
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Arnaud Bourreille
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Camille Zallot
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Xavier Hebuterne
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Anthony Buisson
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Jean-Charles Grimaud
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Yoram Bouhnik
Matthieu Allez
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Romain Altwegg
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Stéphanie Viennot
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Lucine Vuitton
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Franck Carbonnel
Stéphane Paul
Kristell Desseaux
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Jérome Lambert
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Abstract

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. DISCUSSION: 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.

Dates and versions

hal-04168366 , version 1 (21-07-2023)

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Gilles Boschetti, Maria Nachury, David Laharie, Xavier Roblin, Cyrielle Gilletta, et al.. Efficacy and Safety of Infliximab Retreatment in Crohn's Disease: A Multicentre, Prospective, Observational Cohort (REGAIN) Study from the GETAID. The American Journal of Gastroenterology, 2022, 117 (9), pp.1482-1490. ⟨10.14309/ajg.0000000000001842⟩. ⟨hal-04168366⟩
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