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U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
Date:4/8/2008

riod B) phases of the study, the adverse reactions in pediatric patients were similar in type and frequency to those seen in adult patients. This was also seen in patients who participated in the open-label (Period C) extension period.

The overall frequency of adverse events in Period A was 70 percent; infections occurred at a frequency of 36 percent. The most common infections were upper respiratory tract infection and nasopharyngitis. The infections resolved without sequelae, and the types of infections were consistent with those commonly seen in outpatient pediatric populations. Other events that occurred at a prevalence of at least five percent were headache, nausea, diarrhea, cough, pyrexia and abdominal pain. A total of six serious adverse events [acute lymphocytic leukemia, ovarian cyst, varicella infection, disease flare (2) and joint wear] were reported during the initial four months of treatment with ORENCIA. There was one case of a hypersensitivity reaction (0.5 percent). During Periods A, B and C, acute infusion-related events occurred at a frequency of four percent, two percent and three percent, respectively, and were consistent with the types of events reported in adults. Upon continued treatment in the open-label extension period, the types of adverse events were similar except for a single patient diagnosed with multiple sclerosis while on open-label treatment.

About Juvenile Idiopathic Arthritis (JIA)

JIA -- also commonly known as Juvenile Rheumatoid Arthritis (JRA) -- is the most common chronic rheumatic disease in children, and it is an important cause of short-term and long-term disability(3). It is an autoimmune disease that causes chronic pain, stiffness and swelling of the joints(4), which may ultimately lead to joint damage and deformities(5). The disease usually begins before the age of 16(6). Juvenile arthritis may affect up to one in every 1,000 children in the United States(6). ORENCIA(R) (abatacept) is one treatment
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SOURCE Bristol-Myers Squibb Company
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