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PATIENTS (PTS) WITH QUIESCENT MILD-TO-MODERATE ULCERATIVE COLITIS (UC) RECEIVING A MULTIPLE-DAILY DOSE MESALAMINE FORMULATION CAN CHANGE TO ONCE- OR TWICE-DAILY MMX™ MESALAMINE AND MAINTAIN REMISSION
WJ Sandborn1, R Karlstadt2, K Barrett3, RE Joseph2
1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA; 2Shire Pharmaceuticals Inc, Wayne, PA, USA; 3Shire Pharmaceuticals Inc., Basingstoke, Hants, UK
PURPOSE: To determine if pts with mild-to-moderate UC whose disease is in remission while receiving a 5-aminosalicylic acid formulation dosed multiple times daily can change to once- (QD) or twice-daily (BID) MMX mesalamine (LIALDA™ [US], MEZAVANT™ XL [UK & Ireland], MEZAVANT™ [elsewhere]) without compromising treatment efficacy.
METHODS: Data were combined from two phase III studies (Lichtenstein et al. 2007 and Kamm et al. 2007 [parent studies]) in which pts received MMX mesalamine 2.4g/d (QD [Kamm et al. 2007] or 1.2g BID [Lichtenstein et al. 2007]), MMX mesalamine 4.8g/d (QD; both studies) or ASACOL® (mesalamine) delayed-release tablets (Procter & Gamble) 2.4g/d (0.8g three times daily [Kamm et al. 2007]). Pts who achieved remission (modified UC Disease Activity Index score of <=1 with rectal bleeding and stool frequency scores of 0, =>1-point reduction in sigmoidoscopy score from baseline, a combined sigmoidoscopy and Physician’s Global Assessment score of <=1, and no mucosal friability) could opt to receive 12-months’ MMX mesalamine 2.4g/d (QD or 1.2g BID) maintenance therapy as part of a phase III, randomized, open-label study (SPD476-303). Remission rates at 12 months were calculated according to the treatment received in the parent studies.
RESULTS: 198 pts received MMX mesalamine or ASACOL in the parent studies and directly entered the maintenance phase of study 303. Of these, 151 were in clinical and endoscopic remission, while 47 were considered well enough by their physician to receive maintenance treatment. Remission rates at month 12 were similar irrespective of the prior 5-ASA treatment in the parent studies: mean remission rates ranged from 73.4–77.8%.
CONCLUSION: MMX mesalamine is an efficacious maintenance therapy for patients with mild-to-moderate UC, irrespective of the prior 5-ASA therapy (MMX mesalamine or ASACOL) used to achieve remission.
Research funded by Shire Pharmaceuticals Inc., Wayne, PA, USA.