Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: Results from the randomised CORE II study

Simon P L Travis, Silvio Danese, Limas Kupcinskas, Olga Alexeeva, Geert D'Haens, Peter R. Gibson, Luigi Moro, Richard Jones, E. David Ballard, Johan Masure, Matteo Rossini, William J. Sandborn

Research output: Contribution to journalArticle

Abstract

Objective Budesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System (MMX) technology to extend release to the colon. This study compared the efficacy of budesonide MMX with placebo in patients with active, mild-to-moderate ulcerative colitis (UC). Design Patients were randomised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg, or Entocort EC 9 mg (budesonide controlled ileal-release capsules; reference arm) or placebo once daily for 8 weeks. The primary endpoint was combined clinical and endoscopic remission, defined as UC Disease Activity Index score ≤1 with a score of 0 for rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a ≤1-point reduction in endoscopic index score from baseline. Results 410 patients were evaluated for efficacy. Combined clinical and endoscopic remission rates with budesonide MMX 9 mg or 6 mg, Entocort EC and placebo were 17.4%, 8.3%, 12.6% and 4.5%, respectively. The difference between budesonide MMX 9 mg and placebo was significant (OR 4.49; 95% CI 1.47 to 13.72; p=0.0047). Budesonide MMX 9 mg was associated with numerically higher rates of clinical (42.2% vs 33.7%) and endoscopic improvement (42.2% vs 31.5%) versus placebo. The rate of histological healing (16.5% vs 6.7%; p=0.0361) and proportion of patients with symptom resolution (23.9% vs 11.2%; p=0.0220) were significantly higher for budesonide MMX 9 mg than placebo. Adverse event profiles were similar across groups. Conclusion Budesonide MMX 9 mg was safe and more effective than placebo at inducing combined clinical and endoscopic remission in patients with active, mild-to-moderate UC.

Original languageEnglish
Pages (from-to)433-441
Number of pages9
JournalGut
Volume63
Issue number3
DOIs
Publication statusPublished - Mar 2014

ASJC Scopus subject areas

  • Gastroenterology

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    Travis, S. P. L., Danese, S., Kupcinskas, L., Alexeeva, O., D'Haens, G., Gibson, P. R., Moro, L., Jones, R., Ballard, E. D., Masure, J., Rossini, M., & Sandborn, W. J. (2014). Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: Results from the randomised CORE II study. Gut, 63(3), 433-441. https://doi.org/10.1136/gutjnl-2012-304258