Strong long-term efficacy and safety data for Orencia

US drug major Bristol-Myers Squibb says 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 (abatacept) in adult rheumatoid arthritis patients who had an inadequate response to methotrexate. According to the firm, the data, which were presented at the American College of Rheumatology annual meeting, held in Boston, show that in these patients the drug provided sustained improvements in ACR responses, physical function and health-related quality of life. These data, which 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.

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