Long-term safety data on Lialda published in leading ...(ment-related AEs were experienced by a t...),Health

Date:6/17/2008

ment-related AEs were experienced by a total of 10.2 percent of patients [11.1 percent of patients (n=225) in the once-daily group and 9.4 percent of patients (n=234) in the twice-daily group]. A total of 3.9 percent of patients experienced serious AEs [4 percent of patients (n=225) in the once-daily group and 3.8 percent of patients (n=234) in the twice-daily group], most of which were gastrointestinal disorders, and only one serious AE was considered to be related to study treatment.

The secondary endpoints of the study evaluated maintenance of remission and relapse rates over 12 months. In the efficacy population at entry (month 0), 78.1 percent of patients (n=219) in the once-daily group and 82.3 percent of patients (n=232) in the twice-daily group were in clinical and endoscopic remission. At month 12, 64.4 percent of patients in the once-daily and 68.5 percent of patients in the twice-daily group were in strictly defined clinical and endoscopic remission (P=0.351). Thus, there was no significant difference between the once-daily and twice-daily groups with respect to strictly defined clinical and endoscopic remission at month 12. Further, 88.9 percent and 93.2 percent of patients in each group, respectively, had maintained clinical remission and were considered "relapse-free".

Study Background

A total of 459 patients were enrolled and randomized in the 303 long-term safety study (246 directly from the parent studies 301 and 302 - Lialda's eight-week, Phase III, placebo-controlled trials that demonstrated efficacy for the induction of remission in active, mild to moderate UC - and 213 patients who received an additional 8 weeks of treatment with Lialda 4.8 g/day to induce remission). Remission was defined using stringent clinical and endoscopic measures: modified UC Disease Activity Index (UC-DAI) score of ≤1, with scores of 0 for rectal bleeding and stool frequency, and a combined Physician's Global Assessment and sigmoidos
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Contact: Blythe Bertolo bbertolo@golinharris.com 312-729-4463 Shire plc Source:Eurekalert

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