Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis.

Abstract

BACKGROUND & AIMS:

Budesonide is a high-potency, second-generation corticosteroid designed to minimize systemic adverse consequences of conventional corticosteroids. We performed 2 randomized, phase 3 trials to evaluate the ability of budesonide rectal foam, formulated to optimize retention and provide uniform delivery of budesonide to the rectum and distal colon, to induce remission in patients with ulcerative proctitis or ulcerative proctosigmoiditis.

METHODS:

Two identically designed, randomized, double-blind, placebo-controlled trials evaluated the efficacy of budesonide foam for induction of remission in 546 patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis who received budesonide foam 2 mg/25 mL twice daily for 2 weeks, then once daily for 4 weeks, or placebo.

RESULTS:

Remission at week 6 occurred significantly more frequently among patients receiving budesonide foam than placebo (Study 1: 38.3% vs 25.8%; P = .0324; Study 2: 44.0% vs 22.4%; P < .0001). A significantly greater percentage of patients receiving budesonide foam vs placebo achieved rectal bleeding resolution (Study 1: 46.6% vs 28.0%; P = .0022; Study 2: 50.0% vs 28.6%; P = .0002) and endoscopic improvement (Study 1: 55.6% vs 43.2%; P = .0486; Study 2: 56.0% vs 36.7%; P = .0013) at week 6. Most adverse events occurred at similar frequencies between groups, although events related to changes in cortisol values were reported more frequently with budesonide foam. There were no cases of clinically symptomatic adrenal insufficiency.

CONCLUSIONS:

Budesonide rectal foam was well tolerated and more efficacious than placebo in inducing remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. ClinicalTrials.gov ID: NCT01008410 and NCT01008423.

• Authors: William J Sandborn, Brian Bosworth, Salam Zakko, Glenn L Gordon, David R Clemmons, Pamela L Golden, Robert L Rolleri, Jing Yu, Andrew C Barrett, Enoch Bortey, Craig Paterson, William P Forbes
• Journal: Gastroenterology (Gastroenterology) Vol. 148 Issue 4 Pg. 740-750.e2 (Apr 2015) ISSN: 1528-0012 [Electronic] United States
• PMID: 25644096 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Glucocorticoids
• Budesonide

Topics

• Administration, Rectal
• Administration, Topical
• Adult
• Budesonide (administration & dosage)
• Colon, Sigmoid
• Double-Blind Method
• Female
• Glucocorticoids (administration & dosage)
• Humans
• Male
• Middle Aged
• Proctitis (drug therapy)
• Proctocolitis (drug therapy)
• Remission Induction (methods)
• Treatment Outcome
• Ulcer (drug therapy)