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Oral prolonged release beclomethasone dipropionate and prednisone in the treatment of active ulcerative colitis: results from a double-blind, randomized, parallel group study

Am J Gastroenterol. 2015 May;110(5):708-15. doi: 10.1038/ajg.2015.114. Epub 2015 Apr 14.

Abstract

Objectives: Double-blind study comparing efficacy and safety of the topically acting corticosteroid beclomethasone dipropionate (BDP) to prednisone (PD) in patients with active, mild-to-moderate ulcerative colitis (UC).

Methods: Overall, 282 patients were randomized to receive BDP-prolonged release tablets 5 mg once daily for 4 weeks and then every other day for an additional 4 weeks or oral PD 40 mg once daily for the initial 2 weeks tapered of 10 mg every 2 weeks during the 8-week study period. Efficacy end point was the non-inferiority of BDP vs. PD in terms of Disease Activity Index (DAI) score <3 or reduction by at least 3 points for patients with a baseline DAI ≥7 at week 4. Safety end point was the proportion of patients with steroid-related adverse events (AEs) and cortisol <150 nmol/l at week 4.

Results: DAI response rates at week 4 were 64.6% and 66.2% with BDP and PD, respectively, demonstrating non-inferiority of BDP vs. PD (delta: -1.56; 95% confidence interval (CI) -13.00-9.88, P=0.78). Patients with steroid-related AEs and cortisol <150 nmol/l at week 4 were 38.7% in the BDP group and 46.9% in the PD group (P=0.17 between groups). No safety signals were observed in both the groups.

Conclusions: BDP was non-inferior to PD in the treatment of active UC, with a good safety profile in both the groups.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Beclomethasone / administration & dosage*
  • Beclomethasone / adverse effects
  • Colitis, Ulcerative / drug therapy*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Hydrocortisone / blood
  • Intention to Treat Analysis
  • Male
  • Middle Aged
  • Prednisone / administration & dosage*
  • Prednisone / adverse effects
  • Severity of Illness Index
  • Tablets, Enteric-Coated
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • Tablets, Enteric-Coated
  • Beclomethasone
  • Prednisone
  • Hydrocortisone