MMX™ Mesalamine Is Effective for the Maintenance of Ulcerative Colitis Remission in Both Left-Sided and Extensive Disease

Abstract

Purpose: A combined analysis of two phase III, placebo-controlled studies (SPD476–301 and -302) has demonstrated mesalamine with MMX Multi Matrix System® (MMX) technology (LIALDA™, also known as MEZAVANT™ XL in the UK and Ireland, and as MEZAVANT™ elsewhere; hereafter referred to as MMX mesalamine) to be efficacious for the induction of remission of active, mild-to-moderate ulcerative colitis (UC), in patients with left-sided (distal to the splenic flexure) or extensive (involving the transverse colon) disease. In a subsequent 12-month extension study (SPD476–303), MMX mesalamine 2.4 g/day has demonstrated efficacy for maintenance of UC remission. Here we present a post-hoc analysis of 12-month remission rates with MMX mesalamine therapy in patients with a medical history of either left-sided or extensive UC. Methods: Patients were randomized to MMX mesalamine 2.4 g/day given once daily (QD) or 1.2 g given twice daily (BID) for 12 months. Remission was defined as a modified Ulcerative Colitis Disease Activity Index score ≤1, calculated as: scores of 0 for rectal bleeding and stool frequency, a combined Physician's Global Assessment and sigmoidoscopy score of ≤1, no mucosal friability, and a sigmoidoscopy score reduction of ≥1 from baseline. Results: In total, 451 patients were included in the efficacy population. Of the 450 with known extent of disease, 67.0% (233/348) and 64.7% (66/102) of patients with left-sided or extensive disease, respectively, were in remission at month 12. The results were similar with once- or twice-daily treatment in patients with left-sided (QD = 65.5%, BID = 68.4%, P= 0.570) or extensive disease (QD = 60.4%, BID = 68.5%, P= 0.393). Conclusion: MMX mesalamine 2.4 g/day is effective for the maintenance of remission of mild-to-moderate UC in both left-sided and extensive disease.