Bristol-Myers Squibb announced the results of Year 2 data from its Phase 3b study AMPLE (Abatacept Versus Adalimumab Comparison Biologic-Naïve rheumatoid arthritis Subjects With Background Methotrexate) that compared the safety and efficacy of subcutaneous (SC) abatacept (Orencia; Bristol-Myers Squibb) vs. adalimumab (Humira; AbbVie).
AMPLE was a randomized, investigator-blinded multinational study of 24 months duration with a 12 month efficacy primary endpoint. A total of 646 adult biologic-naïve patients with active moderate-to-severe rheumatoid arthritis and inadequate response to methotrexate were evaluated. Patients were randomized to either 125mg abatacept SC weekly + methotrexate or adalimumab + methotrexate based on ACR20 (American College of Rheumatology 20% improvement) response at 12 months.
Year 2 results reiterated the Year 1 data confirming comparable efficacy of abatacept + methotrexate vs. adalimumab + methotrexate based on ACR20. Among the two treatment groups, ACR50, ACR70, ACR90, and DAS-28-CRP were found to be similar. Regarding radiographic progression, 85% of patients on abatacept + methotrexate and 84% of patients on adalimumab + methotrexate achieved non-progression at two years.
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