title: Budesonide for maintenance of remission in patients with Crohn's disease in medically induced remission: a predetermined pooled analysis of four randomized, double-blind, placebo-controlled trials.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of oral budesonide for maintenance of remission in patients with mild to moderately active Crohn's disease (CD) of the ileum and/or ascending colon.
  
  
  METHODS
  Four double-blind, placebo-controlled trials with identical protocols were combined according to a predetermined analysis plan. Three hundred eighty patients with CD in medically induced remission (CD activity index [CDAI]< or =150) were randomized to receive oral budesonide 3 mg, 6 mg, or placebo daily for 12 months. The primary outcome measure was time to relapse (increase in CDAI of 60 points above baseline and >150).
  
  
  RESULTS
  The median time to relapse was 268, 170, and 154 days for budesonide 6 mg, budesonide 3 mg, and placebo groups, respectively (p= 0.0072). The frequency of adverse events and glucocorticosteroid side effects were similar in all groups.
  
  
  CONCLUSIONS
  Budesonide 6 mg/day is effective for prolonging time to relapse and for significantly reducing rates of relapse at 3 and 6 months but not 12 months in patients with CD in medically induced remission.
authors.affiliation: Mayo Clinic, Rochester, Minnesota 55905, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Robert
authors.initials: R
authors.lastname: Löfberg
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Hanauer
authors.forename: Massimo
authors.initials: M
authors.lastname: Campieri
authors.forename: Gordon R
authors.initials: GR
authors.lastname: Greenberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D019819:Budesonide / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D019819:Budesonide