Maintenance of remission in patients with ulcerative colitis with once- or twice-daily MMX™ mesalazine: results of an international multicentre randomised trial

Introduction: MMX Multi Matrix System® (MMX) mesalazine (MEZAVANT™; MEZAVANT™ XL [UK and Ireland]; LIALDA™ [USA]) is a once daily, high-strength (1.2g/tablet), prolonged-release formulation of 5-aminosalicylic acid (5-ASA). In this study, the safety and efficacy of MMX mesalazine when dosed once or twice daily, was evaluated in patients whose ulcerative colitis (UC) was in remission.

Methods: Patients enrolled into this randomised, multicentre, open-label, long-term trial (SPD476–303) had previously had active mild-to-moderate UC and had achieved strictly-defined clinical and endoscopic remission (UC disease activity index ≤1 calculated as scores of 0 for rectal bleeding and stool frequency, a combined sigmoidoscopy and physcian's global assessment score of ≤1, no mucosal friability, and at least a 1-point reduction in sigmoidoscopy score from baseline) in one of two phase III, MMX mesalazine studies. Additionally, patients not meeting the above criteria, but considered in remission by their physician, were enrolled into the study. Patients were randomised to receive MMX mesalazine 2.4g/d once daily (2×1.2g tablet) or twice daily (1×1.2g tablet twice daily) for 12 months.

Results: A total of 459 patients were randomised, of whom 362 were in clinical and endoscopic remission at week 0, and 97 were deemed well enough to receive maintenance treatment. Of the 362 patients in strictly-defined remission at month 0, 68% in the once-daily and 72% in the twice-daily groups, remained in strictly-defined clinical and endoscopic remission (using the same criteria) at month 12 defined. The proportion of patients who had not clinically relapsed (defined as a need for alternative UC treatment), was 89 and 93%, in the once- and twice-daily groups respectively, at 12 months. MMX mesalazine was found to be well tolerated in both treatment arms.

Conclusions: MMX mesalazine 2.4g/day (given once or twice daily), has been shown to be well tolerated and effective in maintaining clinical and endoscopic remission in UC, when administered as either a once- or twice-daily dose. As 2.4g/day therapy requires only two tablets, patient compliance may be improved by utilisation of a once-daily dosing regimen. In turn, this may lead to less frequent disease relapses.