The efficacy of MMX™ mesalazine as the sole medication for the induction and maintenance of remission in patients with mild-to-moderate ulcerative colitis treated over 14–16 months

Introduction: MMX Multi Matrix System™ (MMX) mesalazine (MEZAVANT™; MEZAVANT™ XL [UK and Ireland]; LIALDA™ [USA]) has demonstrated efficacy for the induction of remission of mild-to-moderate ulcerative colitis (UC) in two phase III, placebo-controlled trials (SPD476–301 and -302) and for the maintenance of remission in a phase III, open-label extension study (SPD476–303). In this analysis, we have calculated the proportion of patients who achieved clinical and endoscopic remission without disease relapse while receiving MMX mesalazine as their sole therapy.

Methods: During the parent studies, patients received MMX mesalazine 2.4g/d (once daily or 1.2g twice daily), 4.8g/d (once daily) or placebo for 8 weeks. Patients not achieving remission in the parent studies could receive an additional 8 weeks' MMX mesalazine therapy (4.8g/d [2.4g twice daily; 303 8-week extension study]). Patients who were in remission after the parent studies or the 303 extension study could then receive 12 months' MMX mesalazine 2.4g/d (once daily or 1.2g twice daily; 303 maintenance study). Clinical and endoscopic remission rates were calculated in patients after 8 weeks' initial MMX mesalazine therapy and after an additional 8 weeks' MMX mesalazine therapy (303 8-week extension study). Remission rates were defined as modified UC Disease Activity Index score of ≤1, calculated as: stool frequency and rectal bleeding scores of 0, no mucosal friability and ≥1-point reduction in sigmoidoscopy score from baseline. In the 303 maintenance study, relapse was defined as a requirement for alternative treatment due to UC exacerbation.

Results: In total, 220/346 patients (63.6%) achieved clinical and endoscopic remission following 8–16 weeks MMX mesalazine therapy. Of these 220 eligible patients, 218 entered the 12 month maintenance phase, of whom 89.9% (196/218) were relapse free at study end. Overall, 56.6% (196/346) of patients who started MMX mesalazine therapy both achieved and were maintained in clinical and endoscopic remission for 12 months.

Conclusions: These data suggest that more than half of patients with mild-to-moderate UC can be effectively treated with MMX mesalazine alone, achieving both clinical and endoscopic remission and experiencing no relapses over a 1-year period.