HOME
Return to Table of Contents
MMX™ MESALAMINE AS THE SOLE MEDICATION FOR THE INDUCTION OF REMISSION AND PREVENTION OF RELAPSE IN MILD-TO-MODERATE ULCERATIVE COLITIS (UC)
R Panaccione1, R Diebold2, K Barrett3, R Karlstadt2, RE Joseph2
1Division of Gastroenterology, University of Calgary, Calgary, Alberta; 2Shire Pharmaceuticals Inc., Wayne, PA, United States; 3Shire Pharmaceuticals Inc., Basingstoke, Hampshire, United Kingdom
PURPOSE: To determine the efficacy of MMX mesalamine (Lialda™ [US], Mezavant™ XL [UK and Ireland], Mezavant™ [elsewhere]) as the sole therapy for induction of remission and prevention of relapse in mild-to-moderate UC.
METHODS: Induction of remission: in two phase III studies (Lichtenstein et al. 2007; Kamm et al. 2007), patients (pts) received MMX mesalamine 2.4g/d (once daily [QD; Kamm et al. 2007] or 1.2g twice daily [BID; Lichtenstein et al. 2007]), 4.8g/d (QD [Kamm et al. 2007]) or placebo (both studies) for 8 weeks. Those pts who did not achieve remission in either could receive an additional 8 weeks’ MMX mesalamine therapy (4.8g/d [2.4g BID; SPD476-303 8-week extension study]). Prevention of relapse: pts in remission after any of the three induction trials could choose to be randomized to MMX mesalamine 2.4g/d or 1.2g BID for 12 months (303 maintenance study).
ANALYSES: only pts who had received MMX mesalamine were included in these analyses. Clinical and endoscopic remission rates (modified UC Disease Activity Index score of <=1 calculated as: rectal bleeding and stool frequency scores of 0, =>1-point reduction in sigmoidoscopy score from baseline, a combined sigmoidoscopy and Physician’s Global Assessment sore of <=1, and no mucosal friability) were calculated for pts after 8 weeks’ initial MMX mesalamine therapy and after an additional 8 weeks’ MMX mesalamine therapy (303 8-week extension study). Relapse rates at 12 months in the 303 maintenance study were also calculated.
RESULTS: Induction of remission: 63.6% of pts (220/346) achieved remission following 8-16 weeks MMX mesalamine therapy. 218 of these pts entered the 12 month maintenance phase, 89.9% (196/218) of whom were relapse free at study end. Prevention of relapse: 56.6% (196/346) of pts who started MMX mesalamine therapy both achieved and were maintained in remission for 12 months.
CONCLUSIONS: Most pts with active, mild-to-moderate UC can achieve remission, and remain relapse-free for =>1 year with MMX mesalamine.
Research funded by Shire Pharmaceuticals Inc., Wayne, PA, USA.