MMX Multi Matrix System® mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials

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To cite this article: W. J. SANDBORN, M. A. KAMM, G. R. LICHTENSTEIN, A. LYNE, T. BUTLER, R. E. JOSEPH MMX Multi Matrix System® mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials Alimentary Pharmacology & Therapeutics (OnlineAccepted Articles). doi:10.1111/j.1365-2036.2007.03361.x

MMX Multi Matrix System® mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials

W. J. SANDBORN11Professor of Medicine, Vice Chairman of the Division of Gastroenterology and Hepatology and Director of the Inflammatory Bowel Disease Interest Group, Mayo Clinic, Rochester, MN, USA;, M. A. KAMM22Professor of Gastroenterology, Chairman of Medicine and Director of the Inflammatory Bowel Disease and Physiology Units, St. Mark's Hospital, London, UK;, G. R. LICHTENSTEIN33Director, Inflammatory Bowel Disease Program, Division of Gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA;, A. LYNE44Shire Pharmaceuticals Inc., Basingstoke, Hampshire, UK;, T. BUTLER55Shire Pharmaceuticals Inc., Wayne, PA, USA. & R. E. JOSEPH55Shire Pharmaceuticals Inc., Wayne, PA, USA.

1Professor of Medicine, Vice Chairman of the Division of Gastroenterology and Hepatology and Director of the Inflammatory Bowel Disease Interest Group, Mayo Clinic, Rochester, MN, USA; 2Professor of Gastroenterology, Chairman of Medicine and Director of the Inflammatory Bowel Disease and Physiology Units, St. Mark's Hospital, London, UK; 3Director, Inflammatory Bowel Disease Program, Division of Gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA; 4Shire Pharmaceuticals Inc., Basingstoke, Hampshire, UK; 5Shire Pharmaceuticals Inc., Wayne, PA, USA.

Address for correspondence: J. Sandborn, MDInflammatory Bowel Disease Clinic, Division of Gastroenterology and HepatologyMayo Clinic200 First Street SW, Rochester, MN 55905, USAE-mail: sandborn.william@..., Telephone: +1 ; Fax: +1

Poster and/or oral presentations based on this pooled study population have been presented at the following congresses: Digestive Diseases Week, May 20-May 25, 2006; United European Gastroenterology Week, October 21–25, 2006; American College of Gastroenterology Congress, October 20–25, 2006.

SUMMARY

Background: MMX™ mesalazine (LIALDA™ [uS], MEZAVANT™ XL [uK and Ireland] MEZAVANT™ [elsewhere]) utilizes MMX Multi Matrix System® (MMX) technology which delivers mesalazine throughout the colon. Two phase III studies evaluated MMX mesalazine in patients with active mild-to-moderate ulcerative colitis.

Methods: Combined data from two 8-week, double-blind, placebo-controlled trials were analyzed. Patients randomized to MMX mesalazine 2.4 g/day (once daily or 1.2 g twice daily), 4.8 g/day (once daily) or placebo were reviewed. The primary endpoint was clinical and endoscopic remission (modified ulcerative colitis-disease activity index of 1 calculated as: rectal bleeding and stool frequency scores of 0, a combined Physician's Global Assessment and sigmoidoscopy score of 1, no mucosal friability and a 1-point reduction in sigmoidoscopy score from week 0).

Results: Data from 517 patients were analyzed. 8-week remission rates were 37.2% and 35.1% in the MMX mesalazine 2.4 g/day and 4.8 g/day groups, versus 17.5% on placebo (P < 0.001, both comparisons). 8-week complete mucosal healing rates were 32% in both MMX mesalazine groups compared with 16% on placebo. Adverse event frequency was similar in all groups.

Conclusions: MMX mesalazine is effective and generally well tolerated for inducing clinical and endoscopic remission of active, mild-to-moderate ulcerative colitis.