Induction of mucosal healing in mild-to-moderate ulcerative colitis in patients treated with MMX mesalamine: established versus newly diagnosed disease

Abstract

MMX mesalamine is a once daily (QD), oral formulation of 5-aminosalicylic acid for the induction and maintenance of remission of mild-to-moderate ulcerative colitis (UC). MMX mesalamine utilizes MMX Multi Matrix System® (Cosmo S.p.A., Milan, Italy) technology to delay and extend delivery of mesalamine (1.2g/tablet) throughout the colon. The induction of clinical and endoscopic remission with this formulation has been demonstrated during two 8-week, phase III trials. Here, we examine the ability of MMX mesalamine to induce mucosal healing in patients with recently diagnosed UC, compared with patients who had a longer duration of disease and a history of clinical relapse. Data from the two 8-week, randomized, double-blind, placebo-controlled, phase III induction of remission studies by Lichtenstein et al. (2007)1 and Kamm et al. (2007)2, were combined. In these trials the same entry criteria and endpoints were applied, and patients with mild-to-moderate UC (modified UC Disease Activity Index [UC-DAI] score: 4-10) received MMX mesalamine 2.4g/d (QD or twice daily), 4.8g QD, or placebo. In this analysis, we examined that rate of mucosal healing (defined as a modified UC-DAI sigmoidoscopy score of 1 or less [patients with mucosal friability were assigned a score of at least 2]) among patients with less than 1 year disease duration, and patients with 1 or more year disease duration with 3 or more relapses in the last 2 years prior to study entry. In total, 340 patients were eligible for analysis in one of the study subgroups. Regardless of recently diagnosed disease or established disease, a greater proportion of patients who received MMX mesalamine achieved mucosal healing compared with placebo (Table). Proportion of patients who achieved clinical and endoscopic remission at Week 8. Proportion of patients who achieved clinical and endoscopic remission at Week 8. MMXmesalamine therapy (2.4 of 4.8g/d) effectively achieved mucosal healing in patients with mild-to-moderate UC regardless of their disease history.MMX mesalamine 4.8g/d appeared to be highly effective for inducing mucosal healing in patients with recently diagnosed disease in particular. Research funded by Shire Pharmaceuticals Inc., Wayne, PA, USA