title: Once-daily MMX(®) mesalamine for endoscopic maintenance of remission of ulcerative colitis.
abstract: OBJECTIVE
  Treatment with mesalamine to maintain endoscopic remission (mucosal healing) of ulcerative colitis (UC) has been shown to reduce the risk of relapse and is the recommended first-line maintenance therapy. To improve treatment adherence, a mesalamine formulation that can be administered once-daily, MMX(®) mesalamine (Lialda; Shire Pharmaceuticals LLC, Wayne, PA), was developed. This study was conducted to determine the efficacy and safety of once-daily MMX mesalamine compared with twice-daily delayed-release mesalamine (Asacol; Warner Chilcott, Dublin, Ireland) for maintaining endoscopic remission in patients with UC.
  
  
  METHODS
  A multicenter, randomized, double-blind, 6-month, active-control trial was conducted to assess the non-inferiority of once-daily MMX mesalamine 2.4 g/day compared with twice-daily delayed-release mesalamine at a total daily dose of 1.6 g/day in patients with UC in endoscopic remission. The primary end point was maintenance of endoscopic remission at month 6 in the per-protocol (PP) population.
  
  
  RESULTS
  Overall, 826 patients were randomized and dosed. The primary objective (non-inferiority) was met. At month 6, 83.7 and 77.8% of patients receiving MMX mesalamine in the PP and intent-to-treat (ITT) populations, respectively, had maintained endoscopic remission compared with 81.5% (PP) and 76.9% (ITT) of patients receiving delayed-release mesalamine (95% confidence interval for difference: -3.9%, 8.1% (PP); -5.0%, 6.9% (ITT)). Time to relapse was not significantly different between the two treatment groups (log-rank test, P=0.5116 (PP); P=0.5455 (ITT)). The proportion of patients with adverse events was 37.1 and 36.0% in patients receiving MMX mesalamine and delayed-release mesalamine, respectively.
  
  
  CONCLUSIONS
  Once-daily dosing of MMX mesalamine 2.4 g/day was shown to be well tolerated and non-inferior to twice-daily dosing with delayed-release mesalamine 1.6 g/day for maintenance of endoscopic remission in patients with UC.
authors.affiliation: Academic Medical Center, Amsterdam, The Netherlands. g.dhaens@amc.uva.nl
authors.forename: Geert
authors.initials: G
authors.lastname: D'Haens
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Karen
authors.initials: K
authors.lastname: Barrett
authors.forename: Ian
authors.initials: I
authors.lastname: Hodgson
authors.forename: Paul
authors.initials: P
authors.lastname: Streck
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D016001:Confidence Intervals; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016145:Endoscopy, Digestive System; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine