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FDA OKs Orencia for Juvenile Arthritis

Drug Is Approved to Treat Moderate to Severe Juvenile Rheumatoid Arthritis
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WebMD Health News

FDA Orencia Juvenile Arthritis

April 10, 2008 -- Children ages 6 and older living with a moderate to severe form of juvenile rheumatoid arthritis (JRA) have a new treatment option. The FDA approved the drug Orencia for pediatric patients after a large study showed that those who received the medication had significantly fewer symptom flare-ups than those who took a dummy pill.

Orencia was approved for the treatment of adult rheumatoid arthritis (RA) in 2005.

JRA is the most common form of arthritis in children. According to the American College of Rheumatology, the disabling autoimmune disease affects about one in every 1,000 children in the U.S. Symptoms range from mild to severe and may include chronic pain, joint swelling, stiffness, joint deformities, and soft tissue damage.

The FDA based its pediatric approval on results from a trial known as AWAKEN. The three-part study evaluated the safety and effectiveness of the drug in patients ages 6 to 17 who had moderately to severely active JRA for an average of four years and whose symptoms did not subside when given one or more disease-modifying antirheumatic drugs (DMARDs) such as methotrexate and anti-TNF drugs, which target an inflammatory protein called TNF (tumor necrosis factor).

The 190 patients enrolled in the first part of the study received Orencia every 14 days for the first month and then every month thereafter. The drug consistently improved symptoms.

In a news release, Edward H. Giannini, DrPH, MSc, says Orencia provides meaningful and sustained improvements in pediatric patients aged 6 and older. Giannini is professor of pediatrics in the division of rheumatology at Cincinnati Children's Hospital Medical Center.

Orencia is given intravenously. It can be used alone or with methotrexate. It should not be taken with anti-TNF drugs or other biologic RA medications such as Kineret.

Serious side effects reported in the AWAKEN trial included leukemia, chickenpox, ovarian cyst, disease flare, and joint deterioration.

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