Bristol-Myers Squibb Co. (BMY) on Wednesday said results of AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis (RA) Subjects With Background Methotrexate) study met its primary endpoint of non-inferiority.
The head-to-head clinical trial of 646 patients compared the subcutaneous formulation of Orencia (abatacept) versus Humira (adalimumab), each on a background of methotrexate or MTX, in biologic naïve patients with moderate to severe RA.
The study showed that Orencia plus methotrexate or MTX achieved comparable rates of efficacy for the American College of Rheumatology criteria of 20 percent response at 1 year of 64.8 percent compared to 63.4 percent Humira plus MTX.
AMPLE is a phase IIIb randomized, investigator-blinded multinational study of 24 months duration with a 12 month efficacy primary endpoint. It is the first head-to-head study in adults with rheumatoid arthritis comparing two biologic drugs each on a background of methotrexate.
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