Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled trial

Gastroenterology. 2006 Apr;130(4):1054-61. doi: 10.1053/j.gastro.2006.02.014.


Background & aims: The aim of this study was to evaluate the usefulness of short-term infliximab combined with azathioprine (AZA) or 6-mercaptopurine (6-MP) in steroid-dependent Crohn's disease patients.

Methods: Patients with active disease despite prednisone given for more than 6 months were eligible and were stratified as follows: the failure stratum consisted of patients receiving AZA/6-MP at a stable dose for more than 6 months, and the naive stratum consisted of patients not treated previously with AZA/6-MP. Patients were randomized to infliximab 5 mg/kg or placebo at weeks 0, 2, and 6. All patients were treated with AZA/6-MP maintained at a stable dose throughout the 52 weeks of the study. The primary end point was remission off steroids at week 24.

Results: Among the 113 enrolled patients (55 in the failure stratum), 57 were assigned to infliximab. At week 24, the success rate (intent-to-treat analysis) was higher in the infliximab group than in the placebo group (57% vs 29%; P = .003); at weeks 12 and 52, the corresponding rates were 75% vs 38% (P < .001) and 40% vs 22% (P = .04), respectively. In each stratum, the success rate was significantly higher in the infliximab group at weeks 12 and 24, and a trend was found at week 52. In the failure stratum, only 27% of the patients in the infliximab group were still in remission off steroids, compared with 52% in the naive stratum. Steroid resistance was less common and the cumulative dose of prednisone was lower in the infliximab group.

Conclusions: Infliximab plus AZA/6-MP is more effective than AZA/6-MP alone in steroid-dependent Crohn's disease patients.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Inflammatory Agents / adverse effects*
  • Anti-Inflammatory Agents / therapeutic use
  • Antibodies, Monoclonal / therapeutic use*
  • Azathioprine / therapeutic use*
  • Colonoscopy
  • Crohn Disease / drug therapy*
  • Crohn Disease / pathology
  • Double-Blind Method
  • Drug Therapy, Combination
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Infliximab
  • Prednisone / adverse effects*
  • Prednisone / therapeutic use
  • Substance-Related Disorders / etiology*
  • Treatment Outcome


  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal
  • Gastrointestinal Agents
  • Infliximab
  • Azathioprine
  • Prednisone