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Gut doi:10.1136/gutjnl-2012-304258
  • Inflammatory bowel disease
  • Original article

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

Open Access
  1. William J Sandborn11
  1. 1Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK
  2. 2Istituto Clinico Humanitas, Milan, Italy
  3. 3Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania
  4. 4Regional Clinical Hospital named after N.A. Semachko, Nizhny Novogrod, Russian Federation
  5. 5Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands
  6. 6Department of Gastroenterology, Alfred Hospital and Monash University, Melbourne, Australia
  7. 7Cosmo Technologies Ltd, Dublin, Ireland
  8. 8Santarus, San Diego, California, USA
  9. 9Ferring Pharmaceuticals, St Prex, Switzerland
  10. 10CROSS Metrics S.A., Mendrisio, Switzerland
  11. 11Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
  1. Correspondence to Dr Simon P L Travis, Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford OX3 9DU, UK; simon.travis{at}ndm.ox.ac.uk
  • Received 4 December 2012
  • Revised 25 January 2013
  • Accepted 27 January 2013
  • Published Online First 22 February 2013

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.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode

Open Access


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