title: Clinical trial: benefits and risks of immunomodulators and maintenance infliximab for IBD-subgroup analyses across four randomized trials.
abstract: BACKGROUND
  Benefits and risks of concomitant immunomodulators and maintenance infliximab in inflammatory bowel disease (IBD) patients have not been adequately evaluated.
  
  
  OBJECTIVE
  To assess the effect of concomitant immunomodulator and infliximab maintenance therapy using data from four prospective, randomized Phase 3 trials in IBD patients.
  
  
  METHODS
  Overall, 1383 patients from ACCENT I and ACCENT II [luminal and fistulizing Crohn's disease trials] and ACT 1 and ACT 2 [ulcerative colitis trials] were analysed. Patients were treated with placebo or infliximab 5 or 10 mg/kg at weeks 0, 2 and 6 followed by every-8-week maintenance therapy. Clinical response, clinical remission, fistula response, complete fistula response, infection and infusion reaction rates; serum infliximab concentrations and immunogenicity were summarized by baseline concomitant immunomodulator subgroup (use or non-use).
  
  
  RESULTS
  Overall, almost 40% of evaluated IBD patients received concomitant immunomodulators. Efficacy, infection, and serious infection rates were generally similar in patients who received maintenance therapy with or without concomitant immunomodulators. There were no consistent differences in serum infliximab concentrations with or without immunomodulators in patients who received scheduled maintenance therapy. Concomitant immunomodulators reduced infusion reactions and immunogenicity.
  
  
  CONCLUSIONS
  Concomitant immunomodulators did not improve efficacy or pharmacokinetics in IBD patients who received maintenance infliximab.
authors.affiliation: Division of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA. grl@uphs.upenn.edu
authors.forename: G R
authors.initials: GR
authors.lastname: Lichtenstein
authors.forename: R H
authors.initials: RH
authors.lastname: Diamond
authors.forename: C L
authors.initials: CL
authors.lastname: Wagner
authors.forename: A A
authors.initials: AA
authors.lastname: Fasanmade
authors.forename: A D
authors.initials: AD
authors.lastname: Olson
authors.forename: C W
authors.initials: CW
authors.lastname: Marano
authors.forename: J
authors.initials: J
authors.lastname: Johanns
authors.forename: Y
authors.initials: Y
authors.lastname: Lang
authors.forename: W J
authors.initials: WJ
authors.lastname: Sandborn
mesh_terms: D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab; D008297:Male; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D007155:Immunologic Factors; D007166:Immunosuppressive Agents; D000069285:Infliximab