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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

eline 0.61 vs. 1.47, respectively; p-value less than 0.01). Secondary endpoints included ACR 20, 50, and 70 over time, major clinical response (45 percent for ORENCIA plus MTX), DAS at one year (42.5 percent vs. 9.9 percent, respectively; p-value less than 0.001), joint space narrowing (mean change from baseline 0.46 vs. 0.97, respectively; p-value less than 0.01), total Sharp scores at one year (mean change from baseline 1.07 vs. 2.43, respectively; p-value less than 0.01), and SF-36 through one year (mean change from baseline 8.44 vs. 5.28, respectively; p-value less than 0.001). ATTAIN was a Phase III multi-center, randomized, double-blind, placebo-controlled trial with 391 patients treated at baseline who had active RA despite anti-TNF therapy (389 included in efficacy analyses). The study was double-blind through six months, followed by an ongoing, open-label, long- term extension study. A total of 217 (from the original 256) patients in the group treated with ORENCIA entered the long-term extensions study. Additional DMARDs, 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 and lack of efficacy

Primary endpoints were ACR 20 at six months ORENCIA vs. placebo (50.4 placebo vs. 19.5 percent, respectively; p-value less than 0.001) and improvement in HAQ-DI at six months (47.3 percent vs. 23.3 percent, respectively; p-value less than 0.001). Secondary endpoints were ACR 20, 50, and 70 over time, DAS28 at six months (DAS28 less than or equal to 3.2, 18 percent and DAS28 less than 2.6; 11.1 percent) and SF-36 at six months (55.6 percent vs. 31.6 percent, respectively; p-value less than 0.001). In five clinical trials, the most serious adverse reactions were serious infections (3 percent ORENCIA(R) (abatacept) vs. 1.9 percent placebo) and malignancies (1.3 percent ORENCIA vs. 1.1 percent placebo). The mos
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SOURCE Bristol-Myers Squibb Company
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