title: Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled trial.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Gastroenterology, Hôpital Saint-Louis, Paris, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Lémann
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Mary
authors.forename: Bernard
authors.initials: B
authors.lastname: Duclos
authors.forename: Michel
authors.initials: M
authors.lastname: Veyrac
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Dupas
authors.forename: Jean Charles
authors.initials: JC
authors.lastname: Delchier
authors.forename: David
authors.initials: D
authors.lastname: Laharie
authors.forename: Jacques
authors.initials: J
authors.lastname: Moreau
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cadiot
authors.forename: Laurence
authors.initials: L
authors.lastname: Picon
authors.forename: Arnaud
authors.initials: A
authors.lastname: Bourreille
authors.forename: Iradj
authors.initials: I
authors.lastname: Sobahni
authors.forename: Jean-Frederic
authors.initials: JF
authors.lastname: Colombel
mesh_terms: D000893:Anti-Inflammatory Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use*; D003113:Colonoscopy; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D011241:Prednisone / Q000009:adverse effects* / Q000627:therapeutic use; D019966:Substance-Related Disorders / Q000209:etiology*; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab; D001379:Azathioprine; D011241:Prednisone