Reintroduction of infliximab in CD

Reintroduction of infliximab in CD

December 6, 2022

Issue 23

Clinical Question

Is reintroducing infliximab after loss of response or intolerance an effective strategy?

Editor’s Bottom Line

Restarting infliximab after previous intolerance or failure can succeed in some patients, but adverse events including infusion reactions are common. The latter are not avoided by concomitant use of immunosuppressants but can be predicted by early testing for anti-infliximab antibodies.


Boschetti G, Nachury M, Laharie D, et al. Efficacy and Safety of Infliximab Retreatment in Crohn’s Disease: A Multicentre, Prospective, Observational Cohort (REGAIN) Study from the GETAID. Am J Gastroenterol. 2022;117(9):1482–90;


This prospective observational study included 69 adults with active Crohn’s disease (CD) treated at 16 academic centers in France between 2015 and 2018. All patients had previously discontinued infliximab due either to loss of efficacy after an initial response lasting at least six months, or after experiencing non-life-threatening intolerance. The researchers reintroduced infliximab a mean 43 months after prior discontinuation.

Patients were tracked for 26 weeks following three infusions of infliximab administered with dexchlorpheniramine and hydrocortisone at weeks 0, 4, and 8. The median duration of CD was 10.1 years, 39% of patients previously had intestinal surgery, 40% had stricturing disease, 28% had penetrating disease, and 54% had a history of perianal disease. The median Crohn’s Disease Activity Index (CDAI) at baseline was 259.

After 26 weeks, 35% of patients achieved clinical remission, defined as CDAI <150, and did not need to discontinue infliximab, receive corticosteroids, undergo surgery or receive another biologic. There were 32 acute infusion reactions in 27 patients and there were 127 infliximab-related adverse events during the study period. Infusion reactions prompted infliximab discontinuation in 20 patients.

The only predictor of lack of infliximab efficacy or infusion reactions at week 26 was the presence of anti-infliximab antibodies four weeks after the initial reintroduction infusion. Baseline anti-drug antibody status did not predict response or tolerance. Use of immunosuppressant medications did not reduce the likelihood of infusion reactions.


Study Design: Prospective observational cohort

Funding: The Association François Aupetit

Allocation: Not applicable

Setting: Multicenter

Level of Evidence: 2b