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Post-Hoc Data Show Daily Activity Participation, Independence and Sleep Quality Improved in Adults with Moderate to Severe Rheumatoid Arthritis After Treatment with ORENCIA(R) (Abatacept)
Date:11/12/2007

ate in daily usual activities using a validated activity participation questionnaire. Patients who were treated with ORENCIA were compared with those in the placebo group. This questionnaire was used to assess the number of days in the past 30 days that a patient was unable to perform his or her usual daily activities, defined as paid or unpaid work, household chores or personal care, due to RA. A change of four days in activity participation was deemed to be clinically meaningful.

The percent of patients demonstrating an ability to participate in daily activities in AIM was 61 percent for ORENCIA vs. 46 percent for placebo at one year, and in ATTAIN was 53 percent vs. 32 percent, 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 as measured by the Short-Form (SF-36).

A separate analysis of the ATTAIN trial presented by Hassett, et al., examined the incidence of improvement in social role functioning and decreased need for help from others at six months for the ORENCIA group compared to placebo. This was assessed using a multidimensional scale for independence that was derived from validated measures (including the Health Assessment Questionnaire [HAQ], SF-36 and activity participation questionnaire) in which patient physical and social independence were evaluated. After a final analysis, this scale was constructed of two factors: socio-emotional role independence (including SF-36 role-physical, role-emotional, social functioning domains and days with activity limitation) and physical independence (including HAQ items on reach help, care help and ambulating help). Interviews with 20 RA patients confirmed the concept of measuring independence using a multidimensio
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SOURCE Bristol-Myers Squibb Company
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