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

doi:10.1056/EVIDoa2200061

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

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
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.)

Original language	English
Journal	NEJM Evidence
Volume	1
Issue number	8
Pages (from-to)	EVIDoa2200061
DOIs	https://doi.org/10.1056/EVIDoa2200061
Publication status	Published - 14 Jun 2022

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10.1056/EVIDoa2200061

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Sine, B., Casper, S., Jørn, B., Risager, C. K., Maria, D-R., Østergaard, T. O., Klaus, B., Wirenfeldt, K. T., Frederik, D. J., Niels, T., Jørgen, J., Akbar, M., Natalia, P., Jens, K., Sven, A., Efsen, D. E., Ida, V., Gerhardt, C. A., Jan, M., ... Andrew, A. M. (2022). Discontinuation of Infliximab Therapy in Patients with Crohn’s Disease. NEJM Evidence, 1(8), EVIDoa2200061. https://doi.org/10.1056/EVIDoa2200061

Sine, B , Casper, S , Jørn, B , Risager, CK, Maria, D-R, Østergaard, TO, Klaus, B, Wirenfeldt, KT, Frederik, DJ, Niels, T, Jørgen, J, Akbar, M, Natalia, P, Jens, K, Sven, A, Efsen, DE , Ida, V, Gerhardt, CA, Jan, M, Taina, S, Steen, AJ, Linda, KHA, Louise, AS, Lars, M, Svetlana, M, Møller, HJ & Andrew, AM 2022, 'Discontinuation of Infliximab Therapy in Patients with Crohn’s Disease', NEJM Evidence, vol. 1, no. 8, pp. EVIDoa2200061. https://doi.org/10.1056/EVIDoa2200061

@article{69ab89f13f83448c82277d76d08a0624,

title = "Discontinuation of Infliximab Therapy in Patients with Crohn{\textquoteright}s Disease",

abstract = "BACKGROUNDWhether infliximab therapy can be successfully discontinued after patients with Crohn{\textquoteright}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{\textquoteright}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; PCONCLUSIONSDiscontinuation of infliximab for patients with Crohn{\textquoteright}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.)",

author = "Buhl Sine and Steenholdt Casper and Brynskov J{\o}rn and Risager, {Christensen Katrine} and Dorn-Rasmussen Maria and {\O}stergaard, {Thomsen Ole} and Bendtzen Klaus and Wirenfeldt, {Klausen Tobias} and Frederik, {Dahlerup Jens} and Thorsgaard Niels and Jahnsen J{\o}rgen and Molazahi Akbar and Pedersen Natalia and Kjeldsen Jens and Almer Sven and Efsen, {Dahl Eva} and Vind Ida and Gerhardt, {Cannon Annett} and Marsal Jan and Sipponen Taina and Steen, {Agnholt J{\o}rgen} and Linda, {Kievit Hendrika Adriana} and Louise, {Aure Synn{\o}ve} and Martinsen Lars and Meisner Svetlana and M{\o}ller, {Hansen Jane} and Andrew, {Ainsworth Mark}",

note = "doi: 10.1056/EVIDoa2200061",

year = "2022",

month = jun,

day = "14",

doi = "10.1056/EVIDoa2200061",

language = "English",

volume = "1",

pages = "EVIDoa2200061",

journal = "NEJM Evidence",

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TY - JOUR

T1 - Discontinuation of Infliximab Therapy in Patients with Crohn’s Disease

AU - Sine, Buhl

AU - Casper, Steenholdt

AU - Jørn, Brynskov

AU - Risager, Christensen Katrine

AU - Maria, Dorn-Rasmussen

AU - Østergaard, Thomsen Ole

AU - Klaus, Bendtzen

AU - Wirenfeldt, Klausen Tobias

AU - Frederik, Dahlerup Jens

AU - Niels, Thorsgaard

AU - Jørgen, Jahnsen

AU - Akbar, Molazahi

AU - Natalia, Pedersen

AU - Jens, Kjeldsen

AU - Sven, Almer

AU - Efsen, Dahl Eva

AU - Ida, Vind

AU - Gerhardt, Cannon Annett

AU - Jan, Marsal

AU - Taina, Sipponen

AU - Steen, Agnholt Jørgen

AU - Linda, Kievit Hendrika Adriana

AU - Louise, Aure Synnøve

AU - Lars, Martinsen

AU - Svetlana, Meisner

AU - Møller, Hansen Jane

AU - Andrew, Ainsworth Mark

N1 - doi: 10.1056/EVIDoa2200061

PY - 2022/6/14

Y1 - 2022/6/14

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; PCONCLUSIONSDiscontinuation 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; PCONCLUSIONSDiscontinuation 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

SP - EVIDoa2200061

JO - NEJM Evidence

JF - NEJM Evidence

IS - 8

ER -

Discontinuation of Infliximab Therapy in Patients with Crohn’s Disease

Abstract

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