ORENCIA® ▼ (abatacept) Demonstrates Comparable Efficacy to Humira® (adalimumab) in Patients with Moderate to Severe Rheuma

 Bristol-Myers Squibb Company [http://www.bms.com ]  today announced the results 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(R) (abatacept)vs. HUMIRA(R) (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.  

    ACR50, 70 and major clinical response (ACR70 for 6 consecutive months), considered to be more stringent measures of efficacy, as well as DAS-28-CRP, were also assessed at 1 year and found to be generally comparable for the two arms. Kinetics of response and inhibition of radiographic progression were generally comparable for the two groups over a 12-month period. Injection-site reactions (a key secondary endpoint) were statistically significantly fewer in the abatacept plus MTX group. Discontinuations due to adverse events were 3.5% for abatacept plus MTX compared to 6.1% for adalimumab plus MTX while discontinuations due to serious adverse events were 1.3% for abatacept plus MTX compared to 3% for adalimumab plus MTX. Autoimmune events (mild to moderate in severity) reported in the abatacept SC plus MTX group was 3.1% and 1.2% in the adalimumab plus MTX group. Other safety outcomes were similar at 12 months. The results of AMPLE were presented today at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.  

    "Results from AMPLE provide important information comparing the efficacy of abatacept SC to adalimumab, including kinetics of response," said Michael Schiff, M.D., M.A.C.R., University of Colorado, and principal AMPLE study investigator. "The results demonstrate comparability between two agents for the primary endpoint of ACR20 and provides relevant data on ACR50 and 70."  

    "AMPLE is the first head-to-head study between two biologics which incorporates radiographic progression endpoints and provides important data on erosions and joint space narrowing in patients using abatacept SC and adalimumab, both on a background of methotrexate," said Désirée van der Heijde, M.D. Ph.D., Professor of Rheumatology, Leiden University Medical Center