MMX mesalamine for induction and maintenance therapy in mild-to-moderate ulcerative colitis

Stephen B. Hanauer, Gary R. Lichtenstein, Michael A. Kamm, William J. Sandborn, Kirstin H. Lees, Karen Barrett, Robyn G. Karlstadt, Ron Diebold, Raymond E. Joseph

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

Two 8-week, randomized, placebo-controlled parent studies, SPD476-301 (by Lichtenstein and associates) and SPD476-302 (by Kamm and colleagues), of MMX Multi Matrix System (MMX) mesalamine have evaluated the induction of remission in ulcerative colitis patients, and a third study has evaluated the maintenance of remission in patients from these parent studies. Here, we examine data only from patients who received MMX mesalamine 2.4 g or 4.8 g daily in these trials. In total, 63.6% of patients (220/346) achieved remission following 8-16 weeks of MMX mesalamine therapy. Among these 220 eligible patients, 218 entered the 12-month maintenance phase, and of this group, 89.9% (196/218) were relapse-free at study end. Overall, 56.6% (196/346) of patients who started MMX mesalamine therapy both achieved and maintained remission for 12 months. The adverse-event profile of MMX mesalamine was similar to the profile of the parent studies' placebo arms at all doses and frequencies. Therefore, the majority of patients with active, mild-to-moderate ulcerative colitis can achieve remission, including complete symptom resolution and mucosal healing, and remain relapse-free for at least 1 year with MMX mesalamine.

Original languageEnglish (US)
Pages (from-to)494-500
Number of pages7
JournalGastroenterology and Hepatology
Volume5
Issue number7
StatePublished - Jul 1 2009

Keywords

  • 5-aminosalicylic acid
  • MMX mesalamine
  • Ulcerative colitis

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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