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MMX™ MESALAMINE MAINTAINS REMISSION FOR AT LEAST 12 MONTHS IN PATIENTS WITH MILD-TO-MODERATE ULCERATIVE COLITIS (UC)
GR Lichtenstein1, K Barrett2, KH Lees3, RE Joseph3
1Division of Gastroenterology, University of Pennsylvania, Philadelphia, PA, USA; 2Shire Pharmaceuticals Inc., Basingstoke, Hants, UK; 3Shire Pharmaceuticals Inc., Wayne, Pennsylvania, USA
PURPOSE: To evaluate the efficacy of MMX™ mesalamine (LIALDA™ [MEZAVANT™ XL in the UK and Ireland; MEZAVANT™ elsewhere]) a novel, high-strength (1.2g/tablet), once-daily (QD) formulation of 5-ASA for the maintenance of remission in patients with mild-to-moderate UC.
METHODS: Patients with UC who achieved clinical and endoscopic remission (defined as a modified UC Disease Activity Index score of <=1, calculated as: scores of 0 for both rectal bleeding and stool frequency; a combined Physician’s Global Assessment and sigmoidoscopy score of <=1; no mucosal friability; and a sigmoidoscopy score reduction of =>1 point from baseline) during studies designed to evaluate MMX mesalamine for the induction of remission could choose to enter an open-label extension study (SPD476-303) for the maintenance of remission. In study 303, patients were randomized to MMX mesalamine 2.4g/day QD or 1.2g twice daily (BID) for 12 months. 12-month remission rates and relapse (defined as withdrawal from the study due to a requirement for alternative treatment for a UC exacerbation, including a dose increase or surgery) rates were determined.
RESULTS: 362 patients in clinical and endoscopic remission entered the maintenance phase of (171 and 191 patients received MMX mesalamine 2.4g/day administered QD or BID, respectively). At month 12, 67.8 and 72.3% of patients in were in strictly defined clinical and endoscopic remission, while 88.7 and 92.5% of patients had not relapsed in the QD and BID groups, respectively.
CONCLUSIONS: Following 12 months’ MMX mesalamine therapy, less than 10% of patients had experienced clinical relapse and more than
two-thirds of patients were in clinical and endoscopic remission.
Research funded by Shire Pharmaceuticals Inc., Wayne, PA, USA