(RTTNews) -  Drug maker Bristol-Myers Squibb Co. (BMY: News ), Wednesday said the U.S. FDA approved a broader labeling for its rheumatoid arthritis drug, Orencia, to include patients with moderate-to-severe rheumatoid arthritis of less than or equal to two years duration. Orencia was initially approved in the treatment of moderate-to-severe rheumatoid arthritis patients who did not respond to other drugs.

The broader labeling approval was based on clinical data from the Abatacept study that showed Orencia helped patients with moderate-to-severe rheumatoid arthritis of less than or equal to two years duration. The U.S. FDA approved on August 25 the addition of data from the AGREE trial.

Bristol-Myers said data indicated that Orencia can inhibit radiographic progression of RA and can improve physical function and health-related quality of life in addition to relieving pain, swelling and fatigue.

The Abatacept study to Gauge Remission and Joint Damage Progression in Methotrexate-Naïve Patients with Early Erosive Rheumatoid Arthritis, known as AGREE trial, showed 41% of patients with Orencia plus methotrexate achieved a DAS28-CRP score of less than 2.6 at 12 months, compared to 23% with those taking methotrexate plus placebo.

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 a low level of disease activity.

Bristol-Myers Squibb also said that additional measures of improvement of signs and symptoms in RA patients were reported at 1 year as per the AGREE study.
Safety experience in the AGREE study was consistent with the Orencia rheumatoid arthritis clinical studies currently included in the prescribing information. The most serious adverse reactions were serious infections observed in 3.0% of patients treated with Orencia and 1.9% of patients treated with placebo. Malignancies were observed in 1.3% of patients treated with Orencia and 1.1% of patients treated with placebo.

The most frequent adverse events occurring in greater than or equal to 10% of patients treated with Orencia were headache, upper respiratory tract infection, nasopharyngitis, and nausea.

The Abatacept study comprised an active-controlled clinical trial in methotrexate-naïve patients with moderate-to-severe rheumatoid arthritis of less than two years disease duration.

RA 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. The condition is more common in women than in men.

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