title: Beclomethasone dipropionate in Crohn's ileitis: a randomised, double-blind trial.
abstract: BACKGROUND
  Steroids, the mainstay of Crohn's disease treatment, have been associated with systemic side effects.
  
  
  OBJECTIVE
  To evaluate the efficacy and tolerability of beclomethasone dipropionate for maintaining remission induced by a short course of systemic steroids in patients with Crohn's ileitis with or without right colonic involvement.
  
  
  METHODS
  Patients (n=84) with active Crohn's disease who achieved remission during a 2-week prednisone run-in period were randomised to receive beclomethasone dipropionate for 24 weeks or continue prednisone for a further 2 weeks followed by placebo for 22 weeks. The primary outcome was relapse rate (Crohn's Disease Activity Index score>150 and an increase of ≥60 points from baseline) or withdrawal due to disease deterioration.
  
  
  RESULTS
  The relapse rate was 23.3% and 53.8% in beclomethasone dipropionate and placebo groups, respectively (p=0.027). According to Kaplan-Meier analysis, the cumulative relapse rate was 38.0% in the beclomethasone dipropionate group and 56.0% in the placebo group (p=0.025). Six percent and 1.7% of all adverse events in the beclomethasone dipropionate and placebo groups, respectively, were endocrine-related.
  
  
  CONCLUSIONS
  These results demonstrate that beclomethasone dipropionate significantly reduces the relapse rate in post-active Crohn's ileitis patients compared with placebo after induction of remission with a short course of systemic steroids, and is well tolerated.
authors.affiliation: Azienda Ospedaliera San Camillo Forlanini, Rome, Italy. prantera@tin.it
authors.forename: Cosimo
authors.initials: C
authors.lastname: Prantera
authors.forename: Marina
authors.initials: M
authors.lastname: Rizzi
authors.forename: Mario
authors.initials: M
authors.lastname: Cottone
authors.forename: Angelo
authors.initials: A
authors.lastname: Casa
authors.forename: Vito
authors.initials: V
authors.lastname: Annese
authors.forename: Giacomo Carlo
authors.initials: GC
authors.lastname: Sturniolo
authors.forename: Stefano
authors.initials: S
authors.lastname: Marconi
authors.forename: Herbert
authors.initials: H
authors.lastname: Lochs
mesh_terms: D000328:Adult; D000368:Aged; D001507:Beclomethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy* / Q000517:prevention & control; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use; D012074:Remission Induction; D055502:Secondary Prevention; D013608:Tablets, Enteric-Coated; D016896:Treatment Outcome; D016903:Drug Monitoring
chemical_list: D005938:Glucocorticoids; D013608:Tablets, Enteric-Coated; D001507:Beclomethasone; D011241:Prednisone