Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study
- Simon P L Travis1,
- Silvio Danese2,
- Limas Kupcinskas3,
- Olga Alexeeva4,
- Geert D'Haens5,
- Peter R Gibson6,
- Luigi Moro7,
- Richard Jones7,
- E David Ballard8,
- Johan Masure9,
- Matteo Rossini10,
- William J Sandborn11
- 1Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK
- 2Istituto Clinico Humanitas, Milan, Italy
- 3Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania
- 4Regional Clinical Hospital named after N.A. Semachko, Nizhny Novogrod, Russian Federation
- 5Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands
- 6Department of Gastroenterology, Alfred Hospital and Monash University, Melbourne, Australia
- 7Cosmo Technologies Ltd, Dublin, Ireland
- 8Santarus, San Diego, California, USA
- 9Ferring Pharmaceuticals, St Prex, Switzerland
- 10CROSS Metrics S.A., Mendrisio, Switzerland
- 11Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
- 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.
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