Shire announces publication of long-term Lialda safety data

Shire has announced the publication of data from a long-term safety and tolerability study of Lialda (mesalamine) for patients with mild-to-moderate ulcerative colitis in the current issue of Gut, the official journal of the British Society of Gastroenterology.

The study evaluated the safety and tolerability of the compound administered as a single daily 2.4g dose or twice-daily 1.2g dose over a 12-month period through the measurement of adverse events, treatment exposure and time to withdrawal.

In total, 37.9 per cent of patients experienced adverse effects, the majority of which were deemed to be mild or moderate.

Gary R Lichtenstein, director of the Centre for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania, said: “This published data demonstrates that Lialda is generally well tolerated and has a strong safety profile.”

He added that secondary endpoints of the study showed that the majority of patients receiving the compound remained in remission during the treatment period.

In March 2008, Shire announced the launch of its On the Road Again education forums to help patients meet the challenges of living with ulcerative colitis.

The firm started the initiative in response to the results of a patient survey completed during 2007.