Abbott's Humira Found Effective in Crohn's Disease Patients With Fistulas
Posted on: Thursday, 13 March 2008, 09:01 CDT
Abbott has announced the first two-year data for Crohn's disease patients with fistulas, which show that more than half of patients receiving Humira had continued fistula healing.
The results were taken from two sub-analyses of fistula patients from Abbott's 854-patient, one-year Phase III Charm trial for Humira. Patients were followed through a second year of therapy into a non-placebo controlled, ongoing open-label extension trial. Fistula healing in these studies was defined as complete cessation of fistula drainage.
Results of the trial showed that Fistula healing was sustained with Humira treatment. More than half of patients (60%) experienced fistula healing at one year with Humira treatment, and 76% had continued fistula healing one more year. Seventy-one percent (50 of 70 patients) had at least a 50% reduction in the number of draining fistulas after treatment with Humira.
More than half had a high quality-of-life score that correlates to clinical remission over two years. This was measured with an inflammatory bowel disease questionnaire (IBDQ), a quality-of-life tool that assesses the impact of chronic medical illness on physical, emotional, and social well-being. Specifically, 54% had IBDQ scores greater than 170 at 56 weeks (26 of 48 patients) and 60% at 116 weeks (29 of 48 patients).
Source: Datamonitor
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