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Time to initial resolution of rectal bleeding and high stool frequency in patients who achieved clinical and endoscopic remission after up to 8 weeks STUDY 303: Long-term Safety Data on Mesalamine for Patients with Ulcerative Colitis Objectives Study design Patient disposition Definitions Safety of 8-week acute extension Efficacy of 8-week acute extension Summary Mesalamine 2.4 and 4.8 g/day Is Effective for the Induction of Remission Lichtenstein et al.1 and Kamm et al.2 studies: Two double-blind, placebo-controlled, phase III studies evaluating the efficacy and tolerability of mesalamine Both studies demonstrated mesalamine 2.4 g/day (given q.d. or 1.2 g b.i.d.) and 4.8 g/day (given q.d.) to be efficacious and well tolerated for the induction of remission in patients with active, mild-to-moderate ulcerative colitis Adapted from: 1Lichtenstein et al. Clin Gastroenterol Hepatol 2007;5:95–102. 2Kamm et al. Gastroenterology 2007;132:66–75. Modified* UC-Disease Activity Index Mild (Score = 1) Moderate (Score = 2) Severe (Score = 3) Rectal bleeding Streaks of blood Obvious blood Mostly blood Stool frequency 1-2/day > normal 3-4/day > normal > 4/day > normal Mucosal appearance Erythema Marked erythema Ulceration Decreased vascular pattern Friability Spontaneous bleeding Minimal granularity Granularity Friability Absent vascular pattern * * Bleeding minimal trauma No ulcerations PGA (Physician’s Global Assessment) Mild Moderate * Friability moved from Score of 1 to 2 Adapted from Kamm et al. Gastroenterology 2007;132:66–75. Severe End Point Definitions Relapse: Withdrawal from the study due to a requirement for alternative treatment (including a dose increase or surgery) for an exacerbation of UC Remission: Modified UC-DAI score 1, calculated as a score of 0 for rectal bleeding and for stool frequency, a combined Physician’s Global Assessment (PGA) and sigmoidoscopy score of 1, no mucosal friability, and a sigmoidoscopy score reduction of 1 point or more from baseline Adapted from Kamm et al. 2008;57(7):893-902. STUDY 303 Efficacy Results: 8-Week Acute Extension Phase Up to 8 weeks’ active treatment (n = 107) Up to 16 weeks’ active treatment (n = 78) (n = 78) Prior treatment (n = 41) Number of patients (%) 8-Week Acute Extension Phase: Sigmoidoscopy Scores *Week 0=First study visit of the acute extension phase Adapted from Lichtenstein et al. Poster presented at ACG 2007. STUDY 303 Acute Extension Phase Conclusions1,2 Mesalamine 4.8 g/day (2.4 g dosed b.i.d.) was welltolerated in the 8-week acute extension phase Safety profile similar to that of the parent studies (Lichtenstein et al. and Kamm et al.) Mesalamine 4.8 g/day for up to 4 months was welltolerated Approximately 60% of patients achieved remission, using stringent clinical and endoscopic criteria Adapted from: 1Lichtenstein et al. Poster presented at APhA 2007. 2 Lichtenstein et al. Poster presented at ACG 2007.