title: Infliximab, azathioprine, or combination therapy for Crohn's disease.
abstract: BACKGROUND
  The comparative efficacy and safety of infliximab and azathioprine therapy alone or in combination for Crohn's disease are unknown.
  
  
  METHODS
  In this randomized, double-blind trial, we evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy, and the two drugs combined in 508 adults with moderate-to-severe Crohn's disease who had not undergone previous immunosuppressive or biologic therapy. Patients were randomly assigned to receive an intravenous infusion of 5 mg of infliximab per kilogram of body weight at weeks 0, 2, and 6 and then every 8 weeks plus daily oral placebo capsules; 2.5 mg of oral azathioprine per kilogram daily plus a placebo infusion on the standard schedule; or combination therapy with the two drugs. Patients received study medication through week 30 and could continue in a blinded study extension through week 50.
  
  
  RESULTS
  Of the 169 patients receiving combination therapy, 96 (56.8%) were in corticosteroid-free clinical remission at week 26 (the primary end point), as compared with 75 of 169 patients (44.4%) receiving infliximab alone (P=0.02) and 51 of 170 patients (30.0%) receiving azathioprine alone (P<0.001 for the comparison with combination therapy and P=0.006 for the comparison with infliximab). Similar numerical trends were found at week 50. At week 26, mucosal healing had occurred in 47 of 107 patients (43.9%) receiving combination therapy, as compared with 28 of 93 patients (30.1%) receiving infliximab (P=0.06) and 18 of 109 patients (16.5%) receiving azathioprine (P<0.001 for the comparison with combination therapy and P=0.02 for the comparison with infliximab). Serious infections developed in 3.9% of patients in the combination-therapy group, 4.9% of those in the infliximab group, and 5.6% of those in the azathioprine group.
  
  
  CONCLUSIONS
  Patients with moderate-to-severe Crohn's disease who were treated with infliximab plus azathioprine or infliximab monotherapy were more likely to have a corticosteroid-free clinical remission than those receiving azathioprine monotherapy. (ClinicalTrials.gov number, NCT00094458.)
authors.affiliation: Hôpital Claude Huriez and Centre d'Investigation Clinique, Centre Hospitalier Universitaire de Lille, Université Lille Nord de France, Lille, France. jfcolombel@chru-lille.fr
authors.forename: Jean Frédéric
authors.initials: JF
authors.lastname: Colombel
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.forename: Gerassimos J
authors.initials: GJ
authors.lastname: Mantzaris
authors.forename: Asher
authors.initials: A
authors.lastname: Kornbluth
authors.forename: Daniel
authors.initials: D
authors.lastname: Rachmilewitz
authors.forename: Simon
authors.initials: S
authors.lastname: Lichtiger
authors.forename: Geert
authors.initials: G
authors.lastname: D'Haens
authors.forename: Robert H
authors.initials: RH
authors.lastname: Diamond
authors.forename: Delma L
authors.initials: DL
authors.lastname: Broussard
authors.forename: Kezhen L
authors.initials: KL
authors.lastname: Tang
authors.forename: C Janneke
authors.initials: CJ
authors.lastname: van der Woude
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D001379:Azathioprine / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D000069285:Infliximab; D007262:Infusions, Intravenous; D016015:Logistic Models; D008297:Male; D012074:Remission Induction
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D000069285:Infliximab; D001379:Azathioprine