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news.Bristol-Myers Squibb said the results of three post-hoc analyses from two Phase III pivotal trials showed that Orencia improved daily activity participation, such as work or household chores, physical and social-role independence and sleep quality in adult rheumatoid arthritis patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.
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These data are from post-hoc analyses of two Phase III pivotal trials investigating Orencia: AIM (abatacept in inadequate responders to methotrexate) and ATTAIN (abatacept trial in treatment of anti-TNF inadequate responders) presented at the recent ACR Annual Scientific Meeting in Boston, MA.
The percent of patients demonstrating an ability to participate in daily activities in AIM was 61% for Orencia vs. 46% for placebo at one year, and in ATTAIN was 53% vs. 32%, respectively, at six months. The study found that activity gain was correlated to clinical aspects, physical function and health-related quality of life. In a multi-regression analysis, it was determined that key contributors to activity levels included joint counts, patient global assessment, fatigue, physical function and the physical domains.
There was an 18% improvement in optimal sleep scores in the Orencia (abatacept) group versus -12% in the placebo group for the ATTAIN study at six months and a 16% improvement in optimal sleep scores in the Orencia group versus 5% in placebo group for the AIM study at 12 months. Sleep quantity was not significantly different.