Maintenance of remission among patients with Crohn's disease on antimetabolite therapy after infliximab therapy is stopped

Gastroenterology. 2012 Jan;142(1):63-70.e5; quiz e31. doi: 10.1053/j.gastro.2011.09.034. Epub 2011 Sep 22.

Abstract

Background & aims: It is important to determine whether infliximab therapy can be safely interrupted in patients with Crohn's disease who have undergone a period of prolonged remission. We assessed the risk of relapse after infliximab therapy was discontinued in patients on combined maintenance therapy with antimetabolites and identified factors associated with relapse.

Methods: We performed a prospective study of 115 patients with Crohn's disease who were treated for at least 1 year with scheduled infliximab and an antimetabolite and had been in corticosteroid-free remission for at least 6 months. Infliximab was stopped, and patients were followed up for at least 1 year. We associated demographic, clinical, and biologic factors with time to relapse using a Cox model.

Results: After a median follow-up period of 28 months, 52 of the 115 patients experienced a relapse; the 1-year relapse rate was 43.9% ± 5.0%. Based on multivariable analysis, risk factors for relapse included male sex, the absence of surgical resection, leukocyte counts >6.0 × 10(9)/L, and levels of hemoglobin ≤145 g/L, C-reactive protein ≥5.0 mg/L, and fecal calprotectin ≥300 μg/g. Patients with no more than 2 of these risk factors (approximately 29% of the study population) had a 15% risk of relapse within 1 year. Re-treatment with infliximab was effective and well tolerated in 88% of patients who experienced a relapse.

Conclusions: Approximately 50% of patients with Crohn's disease who were treated for at least 1 year with infliximab and an antimetabolite agent experienced a relapse within 1 year after discontinuation of infliximab. However, patients with a low risk of relapse can be identified using a combination of clinical and biologic markers.

Trial registration: ClinicalTrials.gov NCT00571337.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Webcast

MeSH terms

  • Adult
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / adverse effects
  • Antimetabolites / administration & dosage*
  • Antimetabolites / adverse effects
  • Belgium
  • Biomarkers / blood
  • Crohn Disease / blood
  • Crohn Disease / diagnosis
  • Crohn Disease / drug therapy*
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • France
  • Gastrointestinal Agents / administration & dosage*
  • Gastrointestinal Agents / adverse effects
  • Humans
  • Infliximab
  • Kaplan-Meier Estimate
  • Male
  • Proportional Hazards Models
  • Prospective Studies
  • Recurrence
  • Remission Induction
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal
  • Antimetabolites
  • Biomarkers
  • Gastrointestinal Agents
  • Infliximab

Associated data

  • ClinicalTrials.gov/NCT00571337