Results of AMPLE study of Orencia(BMS) presented at EULAR

Results are announced at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology of AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Na�ve rheumatoid arthritis (RA) Subjects With Background Methotrexate), a head-to-head clinical trial of 646 patients comparing the subcutaneous (SC) formulation of Orencia (abatacept) from BMS vs. Humira (adalimumab), each on a background of methotrexate (MTX), in biologic na�ve patients with moderate to severe RA. AMPLE met its primary endpoint (as measured by non-inferiority) and demonstrated that Orencia plus MTX achieved comparable rates of efficacy for the American College of Rheumatology criteria of 20 percent (ACR20) response at 1 year of 64.8% vs. 63.4% Humira plus MTX.Injection-site reactions (a key secondary endpoint) were statistically significantly fewer in the Orencia plus MTX group. Discontinuations due to adverse events were 3.5% for Orencia plus MTX compared to 6.1% for Humira plus MTX while discontinuations due to serious adverse events were 1.3% for Orencia plus MTX compared to 3% for Humira plus MTX. Autoimmune events (mild to moderate in severity) reported in the Orencia SC plus MTX group was 3.1% and 1.2% in the Humira plus MTX group. Other safety outcomes.