Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Issue 3 (22nd February 2013)

• Record Type: Journal Article
• Authors: Travis, Simon P L; Danese, Silvio; Kupcinskas, Limas; Alexeeva, Olga; D'Haens, Geert; Gibson, Peter R; Moro, Luigi; Jones, Richard; Ballard, E David; Masure, Johan; Rossini, Matteo; Sandborn, William J
• Is Part Of: Gut. Volume 63:Issue 3(2014)
• Page Start: 433
• Page End: 441
• Publication Date: 2013-02-22
• Subjects: Inflammatory Bowel Disease -- IBD -- Ulcerative Colitis; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2012-304258
• Languages: English
• ISSNs: 0017-5749

Abstract

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.