Once- or Twice-Daily MMX™ Mesalamine for the Maintenance of Remission of Mild or Moderate Ulcerative Colitis

Abstract

Purpose: Mesalamine with MMX Multi Matrix System® (MMX) technology (LIALDA™, also known as MEZAVANT™ XL in the UK and Ireland, and as MEZAVANT™ elsewhere) is a novel, high-strength formulation of 5-aminosalicylate (5-ASA; 1.2 g per tablet), designed to release 5-ASA throughout the colon. An analysis of combined data from two randomized, phase III trials (SPD476–301 and -302) demonstrated the efficacy of MMX mesalamine for improving remission rates in patients with active, mild (Ulcerative Colitis Disease Activity Index [UC-DAI] score 4-<6) or moderate ulcerative colitis (UC-DAI score 6–10). In a subsequent 12-month extension study (SPD476–303), in patients achieving remission, MMX mesalamine 2.4 g/day was shown to be efficacious for maintenance of remission. Here, data from study 303 were analyzed to assess the efficacy of MMX mesalamine for the maintenance of remission in patients with either mild or moderate ulcerative colitis. Methods: Patients were randomized to receive MMX mesalamine 2.4 g/day (given once daily [QD]) or 2.4 g/day (1.2 g given twice daily [BID]). Data were analyzed to assess remission rates by baseline disease severity. Remission at 12 months was defined as a modified UC-DAI score 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 ≥1-point reduction in sigmoidoscopy score from baseline. Results: In the efficacy population (N = 451), 12-month remission rates were 70.5% (117/166) for patients with mild disease at baseline, and 64.2% (183/285) for patients with moderate disease at baseline. Remission rates were not significantly different in patients receiving MMX mesalamine 2.4 g/day QD or BID for mild disease (69.0 vs 72.2%, P= 0.653) or moderate disease (61.4 vs 66.7%, P= 0.352). Conclusion: MMX mesalamine 2.4 g/day, given QD or BID, is efficacious for the maintenance of remission of both mild and moderate ulcerative colitis.