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New Drug Most Dramatic Advancement in Years In Treating Juvenile Rheumatoid Arthritis

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By News Release • • April 12, 2000

CINCINNATI, March 15 /PRNewswire/ -- A multi-center study conducted by researchers at Children's Hospital Medical Center of Cincinnati shows that nearly 75 percent of children with severe, longstanding juvenile rheumatoid arthritis (JRA) respond, often dramatically, to the drug Enbrel ® (etanercept). The study is published in this week's edition of The New England Journal of Medicine.

"Enbrel represents the most dramatic advancement in treating JRA in recent years and is an improvement over current therapies in terms of both safety and effectiveness," says Daniel J. Lovell, M.D., M.P.H., a pediatric rheumatologist at Cincinnati Children's and principal investigator of the national study. "Some patients who had been wheelchair-bound and so stricken by side effects from their old treatment that they couldn't go to school are walking around, going to school and involved in extracurricular activities within a matter of weeks of taking Enbrel."

The study was conducted in two segments. In the first segment, which evaluated Enbrel's safety, 74 percent of children (51 of 69) between the ages of 4 and 17 showed an improvement in disease response when treated with Enbrel for three months.

In the second segment, half of these 51 patients received Enbrel and half received a placebo. Seventy-two percent of those who received Enbrel completed the second segment without worsening of JRA symptoms, compared to 19 percent who took a placebo.

For those whose symptoms did worsen, it took 116 days on average for those who continued on Enbrel, while it took only 28 days on average for those on a placebo. Overall, 80 percent of the Enbrel group experienced at least a 30 percent improvement in disease activity and impact, and more than 40 percent experienced at least a 70 percent improvement in disease activity.
The multi-center study, coordinated at Cincinnati Children's, shows that Enbrel eases joint pain and swelling and enhances mobility for JRA patients. "Children and teenagers who struggle with this disease, and their families, face the possibility of a lifetime of pain and, often, disability," says Dr. Edward Giannini, professor of pediatrics in Cincinnati Children's division of rheumatology. "Enbrel proves that the principle of attacking a specific aspect of the immune response is an effective way to intervene in the disease process."

Enbrel is a protein-based drug that inhibits the binding of tumor necrosis factor (TNF), a protein secreted by different types of cells that regulates the immune response. Normally, when a person gets a viral or bacterial infection, these proteins help fight off the infection. JRA, however, is an autoimmune disease in which these proteins create a cascade of inflammatory effects in joints that can actually destroy one's own joint tissue. Enbrel acts as a sponge to absorb TNF so that it does not bind to receptors on the surface of certain cells, thereby blocking TNF and suppressing the cascade reaction.

The study was conducted in collaboration with Immunex Corporation and the Pediatric Rheumatology Collaborative Study Group (PRCSG), headquartered at Cincinnati Children's and chaired by Dr. Lovell. Dr. Giannini is senior scientist of the PRCSG.

Based in part on this study, the FDA approved Enbrel for the treatment of polyarticular course JRA (a common form of the disease) in May 1999 and to treat severe to moderate rheumatoid arthritis in November 1999.

Many children in the study have continued on treatment. Studies of these children have concluded that Enbrel is safe and well tolerated even with prolonged use.
JRA is the most common form of childhood arthritis, with about 71,000 cases in the United States, according to the Arthritis Foundation. Symptoms include swelling, pain, limitation of motion, and tenderness of the joints. In some cases, JRA can affect internal organs.
Children's Hospital Medical Center of Cincinnati is one of the nation's leading pediatric research institutions, ranking third among pediatric research centers in NIH funding. Between 1993 and 1998, NIH awards rose from $8 million to $27 million.

Source: Immunex Corporation

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