Clinical data added to ORENCIA labeling help treat patients with rheumatoid arthritis

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Bristol-Myers Squibb Company (NYSE:BMY) announced today that clinical data added to the labeling for ORENCIA® (abatacept) support use of ORENCIA for patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration.

ORENCIA is indicated for reducing 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, anti-rheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with other biologic rheumatoid arthritis therapy, such as anakinra.

The U.S. Food and Drug Administration approved on August 25, 2009, the addition of data from the AGREE trial (Abatacept study to Gauge Remission and joint damage progression in methotrexate-naïve patients with Early Erosive rheumatoid arthritis), an active-controlled clinical trial in methotrexate-naïve patients with moderate to severe rheumatoid arthritis of less than two years disease duration.

“Earlier treatment with a biologic such as ORENCIA, in combination with methotrexate in patients with poor prognostic factors, may help some patients get back to daily activities so often limited by this debilitating disease,” said AGREE study lead investigator Rene Westhovens, M.D., Ph.D., Department of Rheumatology, Katholieke Universiteit Leuven, Belgium.. “The updated labeling is important for rheumatologists as they consider whether ORENCIA is an appropriate treatment for their new-to-biologic adult patients with moderate to severe rheumatoid arthritis. Data have shown that ORENCIA can inhibit radiographic progression of rheumatoid arthritis and improve physical function and health-related quality of life in addition to relieving pain, swelling and fatigue.”

The labeling update marks the first time that the ORENCIA labeling includes disease activity score (DAS28-CRP) data in patients with moderate to severe rheumatoid arthritis of less than or equal to 2 years duration. DAS28-CRP is a combined index that measures the disease activity in patients with rheumatoid arthritis. A DAS28-CRP score of less than 2.6 indicates a low level of disease activity.

Data from the AGREE study show that a greater proportion of patients with ORENCIA plus methotrexate achieved a DAS28-CRP of less than 2.6 at 12 months when compared to those taking methotrexate plus placebo (41 percent vs. 23 percent; P< 0.001). Of patients treated with ORENCIA plus methotrexate who achieved a DAS28-CRP of less than 2.6, there were 54 percent with no active joints, 17 percent had one active joint, 7 percent had two active joints and 22 percent had 3 or more active joints, where an active joint was tender and/or swollen.

In the AGREE trial, joint damage progression was also measured using the Total Sharp Score, which uses X-rays to measure change at Year 1. A Total Sharp Score of zero means no damage. The mean change in Total Sharp Score at 12 months was 0.6 in patients treated with ORENCIA plus methotrexate compared to 1.1 in patients treated with placebo plus methotrexate, and the difference between groups was statistically significant.

In the AGREE study, the ACR 70, 50 and 20 scores -- additional measures of improvement of signs and symptoms in rheumatoid arthritis patients -- were reported at 1 year. For patients taking ORENCIA plus methotrexate, 43 percent achieved ACR70, which means they had a 70 percent improvement in signs and symptoms, while 57 percent achieved a 50 percent improvement (ACR50) and 76 percent of patients achieved at least a 20 percent improvement (ACR20). In patients who received only methotrexate, 27 percent achieved ACR70, 42 percent achieved ACR50 and 62 percent achieved ACR20. These results indicate that treatment of moderate to severe rheumatoid arthritis of less than or equal to 2 years duration with ORENCIA plus methotrexate could benefit some patients.

Safety experience in the AGREE study was consistent with the ORENCIA rheumatoid arthritis clinical studies currently included in the prescribing information. Concurrent therapy with ORENCIA and biologic DMARDs is not recommended. As stated in the prescribing information, in controlled clinical trials, patients receiving concomitant ORENCIA and TNF antagonist therapy experienced more infections (63 percent) and serious infections (4.4 percent) compared to patients treated with only TNF antagonists (43 percent and 0.8 percent, respectively), without an important enhancement of efficacy. The most serious adverse reactions were serious infections (3.0 percent of patients treated with ORENCIA and 1.9 percent of patients treated with placebo) and malignancies (1.3 percent of patients treated with ORENCIA and 1.1 percent of patients treated with placebo). The most frequent adverse events occurring in greater than or equal to 10 percent of patients treated with ORENCIA were headache, upper respiratory tract infection, nasopharyngitis, and nausea.

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