MMX™ Mesalamine Is Effective for the Maintenance of Remission of Mild-to-Moderate Ulcerative Colitis Irrespective of Patients’ Previous Relapse History

Abstract

Purpose: To investigate the effect of relapse history in patients with mild-to-moderate ulcerative colitis (UC) on the efficacy of maintenance therapy with MMX Multi Matrix System® (MMX) mesalamine (LIALDA™[ MEZAVANT™ XL in the UK and Ireland, MEZAVANT™ elsewhere]). Methods: Patients with active, mild-to-moderate ulcerative colitis (UC) in two phase III, randomized, placebo-controlled studies (SPD476–301 and -302), received MMX mesalamine 2.4 or 4.8 g/day, or placebo, for 8 weeks. An ASACOL® (mesalamine) delayed-release tablet (Procter & Gamble Pharmaceuticals, Cincinnati, OH, USA) 2.4 g/day internal reference arm was also included in study 302. Patients not in remission after study 301 or 302 could receive an additional 8 weeks’ high-dose (4.8 g/day) MMX mesalamine therapy as part of a long-term, open-label study (SPD476–303). Patients in remission at the end of study 301, 302 or the 8-week extension phase of 303 could enter the 303 maintenance phase and receive MMX mesalamine 2.4 g/day for 12 months. Remission was defined as a modified UC Disease Activity Index score of ≤1, calculated as: rectal bleeding and stool frequency scores of 0, a combined Physician's Global Assessment score and sigmoidoscopy score of ≤1, no mucosal friability; and ≥1-point reduction in sigmoidoscopy score from baseline. Results: 438 evaluable patients with complete relapse records prior to the parent studies’ baseline entered the 12-month maintenance phase. Overall, 290 patients (66%) achieved remission at 12 months. Of patients who previously experienced <3 relapses in the two years prior to parent study baseline, 70.1% (192/274) achieved remission at 12 months. In comparison, 59.8% (98/164) of patients who previously experienced ≥3 relapses in the two years prior to parent study baseline achieved remission at 12 months. Conclusion: Relapse history may identify patients with difficult-to-control UC in whom long-term remission rates may be reduced. Nevertheless, about 60% of patients who experience ≥3 relapses in the two years prior to receiving treatment with MMX mesalamine are likely to be in remission up to one year later when receiving MMX mesalamine 2.4 g/day maintenance therapy. Further studies are needed to determine if a higher maintenance dose of MMX mesalamine is warranted in patients who are prone to relapse.