Budesonide MMX Increases Rates of Remission in Patients Wtih Active Ulcerative Colitis: Presented at ECCO-IBD

By Chris Berrie

BARCELONA -- February 21, 2012 -- Once daily budesonide multi-matrix (MMX) 9 mg is well tolerated and provides significantly greater rates of clinical and endoscopic remission and symptom resolution in patients with mild to moderate active ulcerative colitis, compared with placebo, researchers said here at the 7th Congress of the European Crohn’s and Colitis Organisation (ECCO-IBD).

Simon Travis, MD, Translational Gastroenterology Unit, Experimental Medicine Division, John Radcliffe Hospital, Oxford, United Kingdom, presented an analysis of 2 multicentre, randomised, double-blind, phase 3 studies here on February 17.

The corticosteroid budesonide has a high first-pass metabolism and low systemic bioavailability. However, this MMX formulation of budesonide is targeted to and dispersed throughout the entire colon.

The objective of each of the studies was to define the efficacy and safety of oral budesonide MMX versus placebo in patients with mild to moderately active ulcerative colitis. The studies comprised a total of 672 patients, of which 210 were randomised to placebo 230 received budesonide MMX 6 mg, and 232 received budesonide 9 mg.

The primary endpoint was clinical and endoscopic remission at week 8, defined by Ulcerative Colitis Disease Activity Index (UC-DAI) ·1, rectal bleeding and stool frequency UC-DAI scores of 0, no mucosal friability at colonoscopy, and ·1 reduction from baseline in endoscopic index score.

Patients receiving budesonide MMX 9 mg had higher rates of clinical and endoscopic remission versus placebo (17.7% vs 6.2%; P =.0002), with a similar trend for budesonide MMX 6 mg (10.9% vs 6.2%; P =.0692).

Symptom resolution was 26.3% in the 9 mg group versus 14.3% in the placebo group (P =.0015).

Clinical improvement and endoscopic improvement were both numerically, but not significantly, greater for budesonide MMX 9 mg, compared with placebo. No improvement was seen with budesonide MMX 6 mg.

Symptom resolution was observed by more patients in the budesonide MMX 9 and 6 mg group, compared with placebo.

There were no significant differences between groups for any adverse events (AEs) or severe AEs. The most common AEs were continued ulcerative colitis, headache, nausea, abdominal pain, and diarrhoea.

“Budesonide MMX could be an alternative treatment option to salicylates and to traditional corticosteroids with systemic side effects, for the induction of remission in active ulcerative colitis,” the authors concluded.

Funding for this study was provided by Cosmo Technologies Ltd., Santarus Inc., and Ferring Pharmaceuticals.

[Presentation title: Induction of Clinical and Endoscopic Remission With Budesonide MMX in Mild to Moderately Active Ulcerative Colitis: Pooled Data From Two Phase 3 Studies. Abstract P162]

To read more Conference Dispatch articles, click here.