Results of AMPLE study of Orencia(BMS) presented at EULAR - 06-Jun-2012

Results are announced at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology of AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve 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 naïve 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.