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MMX Mesalamine Induces Remission in Patients With Mild or Moderate Ulcerative Colitis: Presented at ACG

By Danny Kucharsky

PHILADELPHIA, PA -- October 23, 2007 -- More than 60% of patients with mild or moderate ulcerative colitis remain in remission after 12 months of mesalamine with multi matrix system (MMX mesalamine), according to results of a study presented here at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

The study investigated the effect of baseline disease severity on long-term remission rates in patients with quiescent ulcerative colitis who received MMX mesalamine.

MMX mesalamine is a novel, high-strength formulation of 5-aminosalicylate (5-ASA) 1.2 g per tablet, designed to release 5-ASA throughout the colon

Investigators examined the efficacy results from a long-term study that combined data from two randomised phase 3 studies of MMX mesalamine. Patients with mild to moderate ulcerative colitis who had achieved clinical and endoscopic remission during treatment with MMX mesalamine could choose to be randomised to MMX mesalamine 2.4 g/day (once daily or 1.2 g twice daily) for 12 months.

The study population included several patients who did not meet the strict protocol-defined remission criteria but were considered to be well enough by their physicians to receive maintenance treatment, said lead investigator Remo Panaccione, MD, Director, Inflammatory Bowel Disease Clinic; Director, Gastroenterology Training Program; Associate Professor of Medicine, University of Calgary, Calgary, Alberta, Canada.

A total of 459 patients entered the maintenance phase. Demographic data were similar in the once-daily and twice-daily dosing groups -- 47.1% male and mean age 42.4 years in the once-daily group (n=225); 48.7% male and mean age 42.6 years in the twice-daily group (n=234).

The maintenance phase efficacy population included 451 patients, of whom 166 (36.8%) had mild disease and 285 (63.2%) had moderate disease at baseline. Twelve month remission rates were 70.5% (117 of 166) for patients with mild disease at baseline, and 64.2% (183 of 285) for patients with moderate disease at baseline.

Remission rates were not significantly different in patients receiving MMX mesalamine 2.4 g/day once daily or twice daily for mild disease (69.0 vs 72.2%, P =.653) or moderate disease (61.4 vs 66.7%, P =.352).

Dr. Panaccione concluded that MMX mesalamine 2.4 g once daily or 1.2 g twice daily is efficacious for the induction of remission in patients with either mild or moderate ulcerative colitis.

Funding for this study was provided by Shire Pharmaceuticals Group plc and Gareth Worthington (GeoMed).


[Presentation title: Once-or Twice Daily MMX Mesalamine for the Maintenance of Remission of Mild or Moderate Ulcerative Colitis. Abstract 950]

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