Beclomethasone dipropionate in Crohn's ileitis: A randomised, double-blind trial

• Published in: Digestive and liver disease 2011-06, Vol.43 (6), p.459-464
• Main Authors: Prantera, Cosimo, Rizzi, Marina, Cottone, Mario, Casa, Angelo, Annese, Vito, Sturniolo, Giacomo Carlo, Marconi, Stefano, Lochs, Herbert
• Format: Article
• Language: English
• Subjects: Adult; Aged; Beclomethasone - administration & dosage; Beclomethasone - therapeutic use; Beclomethasone dipropionate; Crohn Disease - drug therapy; Crohn Disease - prevention & control; Crohn's disease; Double-Blind Method; Drug Administration Schedule; Female; Gastroenterology and Hepatology; Glucocorticoids - administration & dosage; Glucocorticoids - therapeutic use; Humans; Kaplan-Meier Estimate; Male; Medication Adherence - statistics & numerical data; Middle Aged; Prednisone - administration & dosage; Prednisone - therapeutic use; Remission; Remission Induction; Secondary Prevention; Tablets, Enteric-Coated; Treatment Outcome
• ISSN: 1590-8658; 1878-3562
• DOI: 10.1016/j.dld.2010.12.001

Abstract Background Steroids, the mainstay of Crohn's disease treatment, have been associated with systemic side effects. Aim 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. Conclusion 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.