Bristol-Myers Squibb Company (NYSE:BMY) today announced two-year results of a study that supports use of ORENCIA® (abatacept) for methotrexate-naive patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration.
The data from the AGREE study, which compared patients treated with ORENCIA plus methotrexate versus patients treated with methotrexate alone, show that patients taking ORENCIA in combination with methotrexate achieved sustained low disease activity scores at 24 months. Of note, 55.2 percent of patients treated with ORENCIA plus methotrexate achieved low disease activity scores (DAS28-CRP less than 2.6, which is a combined index that measures disease activity). Of these patients, more than half had no active joints. The data also showed that ORENCIA plus methotrexate can inhibit radiographic progression of rheumatoid arthritis and improve physical function in addition to relieving pain, swelling and fatigue. The safety profile for the open-label period was similar to the double-blind period of the study.
The data were presented yesterday at the American College of Rheumatology Annual Scientific Meeting in Philadelphia.
“Treating moderate to severe rheumatoid arthritis patients earlier with a biologic such as ORENCIA, in combination with methotrexate in patients with poor prognostic factors, may help some patients return to common everyday activities,” said AGREE study lead investigator Rene Westhovens, M.D., Ph.D., Department of Rheumatology, Katholieke Universiteit Leuven, Belgium. “The data help rheumatologists to better understand when and whether ORENCIA is a treatment option for appropriate new-to-biologic adult patients with moderate to severe rheumatoid arthritis.”
ORENCIA is indicated for reducing the signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis, ORENCIA may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists. ORENCIA should not be administered concomitantly with TNF antagonists. ORENCIA is not recommended for use concomitantly with other biologic rheumatoid arthritis therapy, such as anakinra.
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