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
(PressMethod) - Bristol-Myers Squibb Company (BMY) 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® (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 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.
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 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 were similar at 12 months. The results of AMPLE were presented today at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.
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