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Discontinuation of Infliximab Therapy in Patients with Crohn's Disease

Sine Buhl1, Casper Steenholdt1, Jørn Brynskov1

  • 1Department of Gastroenterology, Copenhagen University Hospital-Herlev and Gentofte, Herlev, Denmark.

NEJM Evidence
|February 6, 2024
PubMed

Insights

Discontinuing infliximab in Crohn's disease patients in remission carries a high risk of relapse. Maintaining infliximab therapy is crucial for sustained remission and preventing disease recurrence.

Area of Science:

  • Gastroenterology
  • Immunology
  • Clinical Therapeutics

Background:

  • Crohn's disease management often involves long-term infliximab therapy.
  • Assessing the safety and efficacy of infliximab discontinuation in patients achieving remission is critical.

Purpose of the Study:

  • To evaluate the risk of relapse after discontinuing infliximab in Crohn's disease patients with sustained remission.
  • To compare relapse rates between infliximab continuation and discontinuation groups.

Main Methods:

  • Multicenter, randomized, double-blind, placebo-controlled withdrawal study.
  • 115 Crohn's disease patients in remission were randomized to continue infliximab or receive placebo for 48 weeks.
  • Primary endpoint: time to relapse.

Main Results:

  • No relapses occurred in the infliximab continuation group (n=59).
  • 23 out of 56 patients (51%) in the discontinuation group relapsed within 48 weeks.
  • Significantly shorter time to relapse and loss of remission in the discontinuation group (P<0.001).

Conclusions:

  • Discontinuation of infliximab in well-controlled Crohn's disease poses a substantial risk of relapse.
  • Continued infliximab therapy is associated with 100% relapse-free survival at 48 weeks.
  • No unexpected adverse events were reported during the study.

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