(RTTNews) -
Monday, drug maker Bristol-Myers Squibb Co. (BMY:
News ) said data from a two-year study on its drug Orencia or abatacept, showed low disease activity, among other improvements, in patients with moderate-to-severe rheumatoid arthritis of less than or equal to two years duration.
The Abatacept study, Gauge Remission and Joint Damage Progression in Methotrexate-Naïve Patients with Early Erosive Rheumatoid Arthritis or AGREE trial, compared patients treated with Orencia plus methotrexate versus patients treated with methotrexate alone.
The results indicated 55.2% patients treated with Orencia plus methotrexate achieved low disease activity with a DAS28-CRP score less than 2.6. DAS28-CRP is a combined index that measures the disease activity in patients with rheumatoid arthritis, with a DAS28-CRP score of less than 2.6 indicating lower level of the disease.
The data also demonstrated the ability of the drug in preventing radiographic progression of the disease and in improving physical function of the patients over the two-year period.
Of 232 patients enrolled, 74.1% showed 50% improvement in signs and symptoms, while 53.9% showed a similar 70% improvement when administered with Orencia plus methotrexate.
On August 25, Orencia obtained a broader labeling to include patients with moderate-to-severe rheumatoid arthritis of less than or equal to two years duration .The FDA approved the broader label after Bristol-Meyer's presented its one-year AGREE trial results.
The trial showed Orencia reduced joint damage progression, measured using the Total Sharp Score, where radiographic data revealed non-progression in 56.8% of the patients for the one-year period.
Rheumatoid Arthritis is a systemic, chronic, autoimmune disease characterized by inflammated joints, causing damage with chronic pain, stiffness, swelling and fatigue. It limits range of motion and results in loss of shape and alignment of joints.
BMY is currently trading at $23.06, up $0.18 or 0.70%, on a volume of 6.25 million on the NYSE.
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by RTT Staff Writer
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