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Five-Year Data Demonstrate Long-Term Efficacy and Safety with ORENCIA(R) (abatacept) in Adults with Rheumatoid Arthritis Who had an Inadequate Response to Methotrexate
Date:11/9/2007

ear 1 and maintained at Year 5.

The safety analysis represents five years of cumulative data. This includes all patients who received at least one dose of ORENCIA during the one-year double-blind period and all patients who entered the open-label period who received at least one dose of ORENCIA plus all patients randomized to receive placebo (n=287). The incidence rates observed during the five-year cumulative period for serious adverse events (SAEs), infections, serious infections, malignancies and autoimmune events were consistent with both the double-blind period and the integrated safety summary, which is comprised of seven core RA studies representing approximately 8,400 patient years of exposure. The incidence rates for SAEs in the double-blind period, five-year cumulative period and the integrated safety summary were 20/100 pt-years, 18.9/100 pt-yrs and 15.4/100 pt-yrs, respectively. The incidence rates for infections in the double-blind period, five-year cumulative period and the integrated safety summary were 94.2/100 pt-years, 77.3/100 pt-yrs and 79.2/100 pt-yrs, respectively. The incidence rates for serious infections in the double-blind period, five-year cumulative period and the integrated safety summary were 2.1/100 pt-years, 3.0/100 pt-yrs and 3.0/100 pt-yrs, respectively. The incidence rates for malignancies in the double-blind period, five-year cumulative period and the integrated safety summary were 2.1/100 pt- years, 1.5/100 pt-yrs and 1.3/100 pt-yrs, respectively. A total of 12 autoimmune disorders, the most frequent of which were psoriasis and cutaneous vasculitis, were reported in 12 patients in the cumulative study period.

During the five-year cumulative period, 32 patients (11.1 percent) discontinued due to SAEs. A total of five deaths occurred through five years of the study; all were considered to be unlikely related or unrelated to study medication.

About ORENCIA(R) (abatacept)

ORENCIA is indicated in the United Sta
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SOURCE Bristol-Myers Squibb Company
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