Discontinuation of Infliximab Therapy in Patients with Crohn’s Disease

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstract

BACKGROUND
Whether infliximab therapy can be successfully discontinued after patients with Crohn’s disease have attained sustained, clinical, biochemical, and endoscopic remission is unknown.
METHODS
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.
RESULTS
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<0.001). At the end of the trial at week 48, relapse-free survival was 100% in the infliximab-continuation group and 51% in the infliximab-discontinuation group. The key secondary end point, time to loss of remission, was significantly shorter among patients discontinuing infliximab therapy than those continuing infliximab (hazard ratio, 0.025; 95% CI, 0.003 to 0.187; P<0.001). No unexpected adverse events were reported.
CONCLUSIONS
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.)
OriginalsprogEngelsk
TidsskriftNEJM Evidence
Vol/bind1
Udgave nummer8
Antal sider11
ISSN2766-5526
DOI
StatusUdgivet - 2022

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