Contact: Jim Feuer (513) 636-4420, [email protected]
Embargoed Until 5:15 p.m. EST, November 9, 1998 New Drug Most Dramatic Advancement in Years In Treating Juvenile Rheumatoid Arthritis
SAN DIEGO -- ENBREL (etanercept), one of the new class of drugs used to treat rheumatoid arthritis in adults, is also effective in children suffering from juvenile rheumatoid arthritis (JRA), according to the first-ever study of a biologic for treatment of JRA.
"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 Children's Hospital Medical Center of Cincinnati and principal investigator of the national study. "Patients who had been wheelchair-bound and so stricken by side effects from their old treatment that they couldn't go to school were up walking around, going to school and involved in extracurricular activities within a matter of weeks of taking ENBREL."
The study, coordinated at Cincinnati Children's, shows that ENBREL eases joint pain and swelling and enhances mobility for JRA patients. Dr. Lovell presented the study data today at the annual scientific meeting of the American College of Rheumatology in San Diego.
"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."
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 and a member of the PRCSG team, which consulted with the FDA on the design and execution of the study.
The study was conducted in two segments. In the first segment, which evaluated ENBREL's safety, 51 patients (out of 69) were determined to have responded to ENBREL. 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 symptoms to worsen 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 and impact.
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.
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 comprehensive pediatric research centers in NIH funding. Between 1993 and 1998, National Institutes of Health awards rose from $8 million to $27 million. Investigators have made major contributions to the advancement of pediatric medicine, including the Sabin oral polio vaccine and Survanta, a drug used to treat respiratory distress syndrome that is estimated to save the lives of at least 2,000 infants each year in the United States. Cincinnati Children's vision is "to be the leader in improving child health."
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ENBREL is a trademark of Immunex Corporation.
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