Five-Year Data Demonstrate Long-Term Efficacy and Safety with ORENCIA(R) (abatacept) in Adults with Rheumatoid Arthritis Who had an Inadequate Response to Me...( - Data Presented at American Colle...),Health

- Data Presented at American College of Rheumatology Annual Meeting -

BOSTON, Nov. 9 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that cumulative five-year data from an open-label long-term extension of a Phase IIb trial demonstrate the long-term efficacy and safety of ORENCIA(R) (abatacept) in adult rheumatoid arthritis (RA) patients who had an inadequate response to methotrexate (MTX). The data show that, in these patients, ORENCIA provided sustained improvements in ACR responses, physical function and health-related quality of life. These data, combined with the retention rates observed in this study, demonstrate that ORENCIA provides durable long-term clinical benefits in patients with active RA who had an inadequate response to MTX. Results of this study were presented at the 2007 American College of Rheumatology (ACR) Annual Scientific Meeting.

"Studying the long-term efficacy of a treatment is important because RA is a chronic disease," said Joel Kremer, M.D., Chief of Rheumatology, Albany Medical College. "These data are important because they show that ORENCIA is efficacious and has an acceptable safety profile over an extended period of time in patients with an inadequate response to methotrexate."

Details of the Study

Patients in the initial one-year, double-blind, placebo-controlled randomized trial received MTX and either ORENCIA (10 mg/kg or 2 mg/kg) or placebo administered as a 30-minute intravenous infusion on Days 1, 15 and 30, and every four weeks thereafter, in addition to MTX. The primary endpoint of the double-blind portion of the study was ACR 20 at 6 months (60 percent for ORENCIA(R) (abatacept) vs. 35.5 percent for placebo). All patie
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