MMX mesalazine for the induction of remission of mild-to-moderately active ulcerative colitis: efficacy and tolerability in specific patient subpopulations

Abstract

Background: Two phase III studies have evaluated mesalazine (mesalamine) with MMX (Multi Matrix System) technology in patients with active mild-to-moderate ulcerative colitis.

Aim: To determine the efficacy of MMX mesalazine for the induction of clinical and endoscopic remission in specific subgroups of patients with active, mild-to-moderate ulcerative colitis.

Methods: Data from two double-blind, placebo-controlled trials were analysed (517 out-patients). Patients were randomized to receive MMX mesalazine [2.4 g/day (once daily or 1.2 g twice daily) or 4.8 g/day (once daily)] or placebo for 8 weeks.

Results: The percentages of patients treated with MMX mesalazine, 2.4 or 4.8 g/day, in clinical and endoscopic remission at week 8 were similar and significantly (P < 0.05) greater than placebo in subgroups stratified by disease extent, disease severity and gender and among patients not previously receiving low-dose 5-aminosalicylic acid. Among patients transferring directly from prior low-dose oral 5-aminosalicylic acid, MMX mesalazine 4.8 g/day was significantly (P = 0.018) more effective than placebo in inducing clinical and endoscopic remission. Efficacy over placebo did not reach significance in patients transferring directly to MMX mesalazine 2.4 g/day.

Conclusion: MMX mesalazine is effective in active UC regardless of disease extent, disease severity, gender and previous, low-dose, 5-ASA therapy.