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PROLONGED THERAPY WITH MMX™ MESALAMINE FOR THE INDUCTION OF REMISSION OF ACTIVE, MILD-TO-MODERATE ULCERATIVE COLITIS (UC)
W Sandborn1, K Barrett2, K Lees3, RE Joseph3
1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA; 2Shire Pharmaceuticals Inc., Basingstoke, Hants, UK; 3Shire Pharmaceuticals Inc., Wayne, Pennsylvania, PA, USA
PURPOSE: To determine the effect of prolonged therapy with MMX mesalamine (LIALDA™ [US], MEZAVANT™ XL [UK & Ireland], MEZAVANT™ [elsewhere]) a novel, high-strength formulation of 5 aminosalicylic acid (5-ASA), in patients (pts) with mild-to-moderate UC who did not achieve remission in two, phase III, placebo (pb)-controlled, 8-week (parent) studies (Lichtenstein et al 2007; Kamm et al. 2007)
METHODS: Pts in the parent studies 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 [both studies]), ASACOL® (mesalamine) delayed-release tablets (Procter & Gamble) 2.4g/d (0.8g three times daily [TID; Kamm et al. 2007]) or pb [both studies] for 8 weeks. Pts not in remission after the parent studies could receive an additional 8 weeks’ high-dose (4.8g/d [2.4g BID]) MMX mesalamine therapy in the extension phase of an open label trial (SPD476-303). Remission rates (modified UC Disease Activity Index score of <=1, calculated as: rectal bleeding and stool frequency scores of 0; a combined Physician’s Global Assessment and sigmoidoscopy score of <=1; no mucosal friability; and =>1-point reduction in sigmoidoscopy score from baseline) were calculated at week 8 of the extension phase.
RESULTS: 304 pts entered the 8-week extension phase and were included in the efficacy population. Overall, 59.5% of pts achieved stringently defined clinical and endoscopic remission. A similar remission rate was observed when data from only those patients who received active treatment (MMX mesalamine or ASACOL) in the parent studies prior to entering the 8-week extension phase were considered (60.9%).
CONCLUSIONS: An additional 8 weeks’ MMX mesalamine therapy was able to induce stringently defined remission in a large proportion of pts failing an initial 8 weeks of 5-ASA therapy.
Research funded by Shire Pharmaceuticals Inc, Wayne, PA, USA