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STUDY 303: Long-term Safety Data on Mesalamine for Patients with Ulcerative Colitis

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

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STUDY 303: Long-term Safety Data on Mesalamine for Patients with Ulcerative Colitis

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  1. Time to initial resolution of rectal bleeding and high stool frequency in patients who achieved clinical and endoscopic remission after up to 8 weeks

  2. STUDY 303:Long-term Safety Data on Mesalamine for Patients with Ulcerative Colitis

  3. Objectives • Study design • Patient disposition • Definitions • Safety of 8-week acute extension • Efficacy of 8-week acute extension • Summary

  4. 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.

  5. Modified* UC-Disease Activity Index * Friability moved from Score of 1 to 2 Adapted from Kamm et al. Gastroenterology 2007;132:66–75.

  6. 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.

  7. STUDY 303 Efficacy Results: 8-Week Acute Extension Phase

  8. Up to 8 weeks’ active treatment Up to 16 weeks’ active treatment (n = 107) (n = 78) (n = 78) (n = 41) Prior treatment

  9. 8-Week Acute Extension Phase:Sigmoidoscopy Scores Number of patients (%) *Week 0=First study visit of the acute extension phase • Adapted from Lichtenstein et al. Poster presented at ACG 2007.

  10. STUDY 303 Acute Extension Phase Conclusions1,2 • Mesalamine 4.8 g/day (2.4 g dosed b.i.d.) was well-tolerated 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 well-tolerated • 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.

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