ORENCIA® ▼ (abatacept) Demonstrates Comparable Efficacy to Humira® (adalimumab) in Patients with Moderate to Severe Rheumatoid Arthritis in First Head-to-Head Study of These Agents

ORENCIA® ▼ (abatacept) Demonstrates Comparable Efficacy to Humira® (adalimumab) in Patients with Moderate to Severe Rheumatoid Arthritis in First Head-to-Head Study of These Agents PR Newswire PARIS, June 6, 2012 PARIS, June 6, 2012 /PRNewswire/ -- ORENCIA demonstrated comparable efficacy to HUMIRA based on a non-inferiority endpoint for ACR20 response at 1 year Kinetics of response for ACR20, 50 and 70, and inhibition of radiographic progression were generally comparable over 12 months AMPLE is the first head-to-head study in adults with rheumatoid arthritis comparing two biologic drugs each on a background of methotrexate Bristol-Myers Squibb Company (NYSE: BMY) today announced the results of AMPLE ( Abatacept Versus Adali mumab Com parison in Bio logic-Naïv e rheumatoid arthritis (RA) Subjects With Background Methotrexate), a head-to-head clinical ® ®trial of 646 patients comparing the subcutaneous (SC) formulation of ORENCIA (abatacept)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 abatacept 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% adalimumab plus MTX.