Discontinuation of Infliximab Therapy in Patients with Crohn’s Disease

Buhl Sine, Steenholdt Casper, Brynskov Jørn, Christensen Katrine Risager, Dorn-Rasmussen Maria, Thomsen Ole Østergaard, Bendtzen Klaus, Klausen Tobias Wirenfeldt, Dahlerup Jens Frederik, Thorsgaard Niels, Jahnsen Jørgen, Molazahi Akbar, Pedersen Natalia, Kjeldsen Jens, Almer Sven, Dahl Eva Efsen, Vind Ida, Cannon Annett Gerhardt, Marsal Jan, Sipponen TainaAgnholt Jørgen Steen, Kievit Hendrika Adriana Linda, Aure Synnøve Louise, Martinsen Lars, Meisner Svetlana, Hansen Jane Møller, Ainsworth Mark Andrew


Whether infliximab therapy can be successfully discontinued after patients with Crohn’s disease have attained sustained, clinical, biochemical, and endoscopic remission is unknown.

We conducted a multicenter, randomized, double-blind, placebo-controlled withdrawal study of infliximab in patients with Crohn’s disease who were in clinical, biochemical, and endoscopic remission after standard infliximab maintenance therapy for at least 1 year. Patients were randomly assigned 1:1 to continue infliximab therapy or to receive matching placebo for 48 weeks. The primary end point was time to relapse.

This study randomly assigned 115 patients to either the infliximab-continuation group or to the infliximab-discontinuation group. No relapses were observed among the 59 patients continuing infliximab, whereas 23 of 56 patients discontinuing infliximab experienced relapse. Time to relapse was significantly shorter among patients who discontinued infliximab than among those who continued infliximab (hazard ratio, 0.080; 95% confidence interval [CI], 0.035 to 0.186; P
Discontinuation of infliximab for patients with Crohn’s disease receiving long-term infliximab therapy and in clinical, biochemical, and endoscopic remission leads to a considerable risk of relapse. (Funded by the Nordic Trial Alliance [NordForsk], the Medical Fund of the Danish Regions [Regionernes Medicin og Behandlingspulje], the Danish Colitis-Crohn Association, and the A.P. Moller Foundation; ClinicalTrials.gov number, NCT01817426; EudraCT number, 2012-002702-51.)
Original languageEnglish
JournalNEJM Evidence
Issue number8
Pages (from-to)EVIDoa2200061
Publication statusPublished - 14 Jun 2022


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