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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

nal scale that included these two factors.

Change in mean score on Factor 1 (socio-emotional role independence) was 0.921 for the ORENCIA group and 0.169 for the placebo group (p-value less than 0.0001). Change in mean score on Factor 2 (physical independence) was 0.499 for the ORENCIA group and 0.078 for the placebo group (p-value equals 0.0029). The study concluded that the multi-dimensional assessment of independence based on items from commonly used measurement tools (Disease Activity Score 28, Health Assessment Questionnaire Disability Index and SF-36) is viable.

An analysis of the AIM and ATTAIN studies, presented by Wells, et al, examined several different aspects of sleep in RA patients. Sleep quality was assessed using the validated Medical Outcomes Study sleep questionnaire (MOS- sleep). The treatment groups were compared on the seven derived MOS-sleep scales: awakened short of breath or with headache, snoring, sleep adequacy, sleep disturbance, drowsiness, and sleep problems Index I and Index II. Sleep problems Index I and II are summary scores based on the mean of several sleep- related issues, and a higher score indicates more severity in sleep problems.* In addition, the study compared sleep duration and optimal sleep based on the MOS-sleep module.

There was an 18 percent improvement in optimal sleep scores in the ORENCIA(R) (abatacept) group versus -12 percent in the placebo group for the ATTAIN study (p-value less than 0.0001) at six months and a 16 percent improvement in optimal sleep scores in the ORENCIA group versus 5 percent in placebo group for the AIM study (p-value equals 0.0214) at 12 months. Sleep quantity was not significantly different. In the ATTAIN study, measurement of sleep adequacy was 9.0 in the ORENCIA group and 0.6 in the placebo group (p-value equals 0.0028), sleep disturbance was -11.3 in the ORENCIA group and -2.9 in the placebo group (p-value equals 0.0005), drowsiness was -10.5 in the ORENCIA group and -1.6
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SOURCE Bristol-Myers Squibb Company
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