Budesonide Multimatrix Is Efficacious for Mesalamine-refractory, Mild to Moderate Ulcerative Colitis: A Randomised, Placebo-controlled Trial.

Abstract

BACKGROUND AND AIMS:

Safety and efficacy of budesonide multimatrix, an oral extended-release second-generation corticosteroid designed for targeted delivery throughout the colon, were examined for induction of remission in patients with mild to moderate ulcerative colitis refractory to baseline mesalamine therapy.

METHODS:

A randomised, double-blind, placebo-controlled, multicentre trial evaluated efficacy and safety of budesonide multimatrix for induction of remission [ulcerative colitis disease activity index score ≥ 4 and ≤ 10] in 510 adults randomised to once-daily oral budesonide multimatrix 9 mg or placebo for 8 weeks. Patients continued baseline treatment with oral mesalamine ≥ 2.4 g/day.

RESULTS:

Combined clinical and endoscopic remission at Week 8 was achieved by 13.0% and 7.5% of patients receiving budesonide multimatrix [n = 230] or placebo [n = 228], respectively, in the modified intention-to-treat population [p = 0.049]. Clinical remission [ulcerative colitis disease activity index rectal bleeding and stool frequency subscale scores of 0] was similar in both groups [p = 0.70]. More patients receiving budesonide multimatrix vs placebo achieved endoscopic remission [ulcerative colitis disease activity index mucosal appearance subscale score of 0; 20.0% vs 12.3%; p = 0.02] and histological healing [27.0% vs 17.5%; p = 0.02]. Adverse event rates were similar [budesonide multimatrix, 31.8%; placebo, 27.1%]. Mean morning cortisol concentrations decreased at Weeks 2, 4, and 8 with budesonide multimatrix but remained within the normal range.

CONCLUSION:

Budesonide multimatrix was safe and efficacious for inducing clinical and endoscopic remission for mild to moderate ulcerative colitis refractory to oral mesalamine therapy.

• Authors: David T Rubin, Russell D Cohen, William J Sandborn, Gary R Lichtenstein, Jeffrey Axler, Robert H Riddell, Cindy Zhu, Andrew C Barrett, Enoch Bortey, William P Forbes
• Journal: Journal of Crohn's & colitis (J Crohns Colitis) Vol. 11 Issue 7 Pg. 785-791 (Jul 01 2017) ISSN: 1876-4479 [Electronic] England
• PMID: 28333362 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2017 European Crohn's and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: [email protected]

Chemical References

• Anti-Inflammatory Agents
• Anti-Inflammatory Agents, Non-Steroidal
• Delayed-Action Preparations
• Mesalamine
• Budesonide
• Hydrocortisone

Topics

• Adult
• Anti-Inflammatory Agents (administration & dosage, therapeutic use)
• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Budesonide (administration & dosage, therapeutic use)
• Colitis, Ulcerative (drug therapy, pathology)
• Colonoscopy
• Delayed-Action Preparations (therapeutic use)
• Double-Blind Method
• Female
• Humans
• Hydrocortisone (blood)
• Intention to Treat Analysis
• Male
• Mesalamine (therapeutic use)
• Middle Aged
• Remission Induction
• Retreatment
• Severity of Illness Index