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- W2912972907 abstract "Purpose: MMX Multi Matrix System® (MMX) mesalamine (LIALDA™[ US] MEZAVANT™ XL [UK and Ireland] and MEZAVANT™[ elsewhere]), is a novel high-strength, once-daily 5-aminosalicylic acid therapy that has been shown to be efficacious for the induction and maintenance of remission of mild-to-moderate ulcerative colitis (UC) in a phase III clinical trial program. Here we examine long-term remission rates in patients who required a MMX mesalamine dose escalation to induce remission. Methods: In two placebo-controlled, phase III clinical trials (SPD476–301 and -302), patients with active, mild-to-moderate UC received MMX mesalamine 2.4 or 4.8 g/day for up to 8 weeks to induce remission. Those patients not in remission at the end of these trials could opt to receive a further 8 weeks’ treatment with MMX mesalamine 4.8 g/day (as part of a two-phase, open-label trial [SPD476–303]). Patients who achieved remission in these studies could choose to receive MMX mesalamine 2.4 g/day maintenance therapy for 12 months (second phase of study 303). In this retrospective analysis, we determined 12-month remission rates for (a) patients who received MMX mesalamine 2.4 g/day as induction therapy and then entered the maintenance study directly; and (b) patients who received 2.4 g/day plus a further 8 weeks of high-dose MMX mesalamine therapy before entering the maintenance phase (2.4 g/day). Results: Seventy-nine patients received MMX mesalamine 2.4 g/day in studies 301 and 302 and entered the maintenance phase directly. A total of 53 patients received MMX mesalamine 2.4 g/day for 8 weeks, plus a further 8 weeks’ MMX mesalamine 4.8 g/day and then entered the 12-month maintenance phase of study 303. Twelve-month remission rates were 73.4% for patients who directly entered the maintenance phase, and 50.9% for those who entered via the 8-week extension phase. Conclusion: In this analysis, in patients initially treated with MMX mesalamine 2.4 g/day, the requirement for further treatment at a higher dose to achieve remission was associated with reduced long-term remission rates. These patients may represent a difficult-to-treat subgroup who may require a higher maintenance dose of MMX mesalamine. Further studies are needed to test this hypothesis." @default.
- W2912972907 created "2019-02-21" @default.
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- W2912972907 date "2007-09-01" @default.
- W2912972907 modified "2023-09-25" @default.
- W2912972907 title "Long-Term Remission Rates in Patients with Mild-to-Moderate Ulcerative Colitis Who Require an MMX™ Mesalamine Dose Increase To Induce Initial Remission" @default.
- W2912972907 doi "https://doi.org/10.14309/00000434-200709002-00937" @default.
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