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Original article
Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study
  1. Simon P L Travis1,
  2. Silvio Danese2,
  3. Limas Kupcinskas3,
  4. Olga Alexeeva4,
  5. Geert D'Haens5,
  6. Peter R Gibson6,
  7. Luigi Moro7,
  8. Richard Jones7,
  9. E David Ballard8,
  10. Johan Masure9,
  11. Matteo Rossini10,
  12. 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

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.

  • Inflammatory Bowel Disease
  • IBD
  • Ulcerative Colitis

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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