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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

in the placebo group (p-value less than 0.0001) sleep problems Index I was -9.5 in the ORENCIA group and -1.4 in the placebo group (p-value less than 0.0001) and Index II was -9.8 in the ORENCIA group and -2.1 in the placebo group (p-value less than 0.0001). MOS-sleep scales measuring awakened short of breath or with headache and snoring were not significantly different in the ATTAIN group. In the AIM study, measurement of sleep disturbance in the ORENCIA group was -13.0 and -8.9 in the placebo group (p-value equals 0.0197), sleep problems Index I was -9.4 in the ORENCIA group and -6.7 in the placebo group (p-value equals 0.0476) and Index II was -10.4 in the ORENCIA group and -7.3 in the placebo group (p-value equals 0.0173). MOS-sleep scales measuring awakened short of breath or with headache, snoring, adequacy or drowsiness were not significantly different in the AIM group.

About AIM and ATTAIN

AIM was a Phase III multi-center, randomized, double-blind, placebo- controlled trial with 652 patients treated at baseline who had active RA despite MTX therapy (638 included in efficacy analyses). The study was double-blind through one year, followed by an ongoing, open-label, long-term extension study. A total of 376 (from the original 424) patients in the group treated with ORENCIA(R) (abatacept) entered the long-term extension study. Additional DMARDs, non-steroidal anti-inflammatory drugs (NSAIDs), and aspirin were added and/or adjusted at the discretion of the investigator in the long- term extension study. Primary reasons for discontinuation in the long-term extension studies were adverse events, withdrawal of consent, and lack of efficacy.

Primary endpoints were ACR 20 at six months ORENCIA vs. placebo (67.9 percent vs. 39.7 percent, respectively; p-value less than 0.001), clinically significant improvement in HAQ-DI at one year (63.7 percent vs. 39.3 percent, respectively; p-value less than 0.001), erosion score at one year (mean change from bas
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SOURCE Bristol-Myers Squibb Company
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