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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

nts completing the double-blind period were eligible to continue in the open-label long-term extension, in which all participants received a fixed dose of ORENCIA approximating 10 mg/kg every four weeks, in addition to MTX. Efficacy, health- related quality of life and safety were assessed.

Of the 235 patients completing the double-blind period, 219 entered the long-term extension (ORENCIA 10 mg/kg=84; ORENCIA 2 mg/kg=68; placebo=67), and 130 (59.4 percent) continued in the trial for five years. Baseline RA characteristics for long-term extension patients were similar between groups at initial randomization (mean disease duration: 8.2 - 9.9 years).

Data included in this as-observed analysis were from the original group receiving a dose approximating 10 mg/kg of ORENCIA in the one-year double blind phase (n=115) through five years' total treatment (n=56). At Year 1, improvements in ACR 20, 50 and 70 responses* observed in this group were 77 percent, 53 percent and 29 percent, respectively. At Year 5, improvements in ACR 20, 50 and 70 responses were sustained (83 percent, 65 percent and 40 percent, respectively). More than one-third of these patients achieved an ACR 70 response at Year 5.

Physical function and health-related quality of life were assessed using the modified Health Assessment Questionnaire Disability Index (mHAQ-DI) and Short-Form 36 (SF-36), respectively. Clinically meaningful improvement in physical function was observed in 54.8 percent of patients at Year 1 and 52.8 percent of patients at Year 5 (n=53). Improvements in health-related quality of life were also maintained at Year 5. The mean improvement from baseline in the physical component summary was 9.7 at Year 1 (mean score 40.6) and was stable at 9.7 at Year 5 (mean score 41.7). The mean improvement in the mental component was 6.1 at Year 1 (mean score 52.3) and 5.4 at Year 5 (mean score 50.8). Improvements in all individual component scores of the SF-36 were also observed at Y
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SOURCE Bristol-Myers Squibb Company
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