New Analyses of long-term LIALDA (mesalamine) data presen...(s of 0 for rectal bleeding and stool fre...),Health

Date:10/15/2007

s of 0 for rectal bleeding and stool frequency, a combined Physician's Global Assessment and sigmoidoscopy score of ≤1, with a sigmoidoscopy score reduction of ≥1 point from baseline and no mucosal friability. Of the 451 patients included in the analysis, this post-hoc analysis showed that 70.5 percent (117/166) of patients with mild ulcerative colitis and 64.2 percent (183/285) of patients with moderate ulcerative colitis were in remission at 12 months.

LIALDA for Maintenance of Remission of Mild-to-Moderate Ulcerative Colitis Irrespective of Patient's Previous Relapse History
Poster Presentation: Sunday, October 14, 2007, Exhibit Hall B, #283

A different post-hoc analysis of secondary endpoints from study 303 was done to understand the effect of relapse history in patients with mild-to-moderate ulcerative colitis on the efficacy of maintenance therapy. A total of 438 patients with complete relapse records at baseline (prior to enrolling in either parent study 301 or 302) were analyzed in this post-hoc analysis with LIALDA 2.4g/day. Of patients who previously experienced <3 relapses in the two years prior to parent study baseline, the analysis showed 70.1 percent (192/274) achieved remission at 12 months. In comparison, 59.8 percent (98/164) of patients who previously experienced ≥3 relapses in the two years prior to parent study baseline achieved remission at 12 months.

LIALDA for Maintenance in Both Left-Sided and Extensive Ulcerative Colitis
Poster Presentation: Tuesday, October 16, 2007, Exhibit Hall B, #949

Another post-hoc analysis of secondary endpoints from study 303 assessed the efficacy of LIALDA 2.4g/day (given once daily or in two divided doses) for the maintenance of remission in ulcerative colitis patients with a medical history of either a left-sided or extensive condition. Of the 450 patients with known extent of disease included in the analysis, it was demonstrated that 67
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Contact: Ashleigh Duchene aduchene@golinharris.com 312-729-4428 Shire plc Source:Eurekalert

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