Discontinuation of Infliximab Therapy in Patients with Crohn’s Disease
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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, Taina; Agnholt, Jørgen Steen; Kievit, Hendrika Adriana Linda; Aure, Synnøve Louise; Martinsen, Lars; Meisner, Svetlana; Hansen, Jane Møller; Ainsworth, Mark Andrew.
In: NEJM Evidence, Vol. 1, No. 8, 2022.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Discontinuation of Infliximab Therapy in Patients with Crohn’s Disease
AU - Buhl, Sine
AU - Steenholdt, Casper
AU - Brynskov, Jørn
AU - Christensen, Katrine Risager
AU - Dorn-rasmussen, Maria
AU - Thomsen, Ole Østergaard
AU - Bendtzen, Klaus
AU - Klausen, Tobias Wirenfeldt
AU - Dahlerup, Jens Frederik
AU - Thorsgaard, Niels
AU - Jahnsen, Jørgen
AU - Molazahi, Akbar
AU - Pedersen, Natalia
AU - Kjeldsen, Jens
AU - Almer, Sven
AU - Dahl, Eva Efsen
AU - Vind, Ida
AU - Cannon, Annett Gerhardt
AU - Marsal, Jan
AU - Sipponen, Taina
AU - Agnholt, Jørgen Steen
AU - Kievit, Hendrika Adriana Linda
AU - Aure, Synnøve Louise
AU - Martinsen, Lars
AU - Meisner, Svetlana
AU - Hansen, Jane Møller
AU - Ainsworth, Mark Andrew
PY - 2022
Y1 - 2022
N2 - BACKGROUNDWhether infliximab therapy can be successfully discontinued after patients with Crohn’s disease have attained sustained, clinical, biochemical, and endoscopic remission is unknown.METHODSWe 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.RESULTSThis 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.CONCLUSIONSDiscontinuation 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.)
AB - BACKGROUNDWhether infliximab therapy can be successfully discontinued after patients with Crohn’s disease have attained sustained, clinical, biochemical, and endoscopic remission is unknown.METHODSWe 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.RESULTSThis 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.CONCLUSIONSDiscontinuation 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.)
U2 - 10.1056/EVIDoa2200061
DO - 10.1056/EVIDoa2200061
M3 - Journal article
VL - 1
JO - NEJM Evidence
JF - NEJM Evidence
SN - 2766-5526
IS - 8
ER -
ID: 346059775