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Enbrel shown safe, effective in children and teenagers with juvenile rheumatoid arthritis

Enbrel® (etanercept) has been shown to be a safe and effective drug in the treatment of children and teenagers with polyarticular juvenile rheumatoid arthritis (JRA), according to clinical trial results reported in the New England Journal of Medicine.

In this clinical trial, 69 children, ages 4 to 17, were injected with Enbrel® twice a week; 74 percent responded with measurable improvement when treated for three months. At the end of three months of treatment, on average, there was a 56 percent decrease in the number of joints with active arthritis, a 75 percent decrease in the amount of joint stiffness and a 63 percent decrease in the amount of joint pain. All measures of arthritis impact symptoms, joint abnormalities, ability to perform daily functions and laboratory tests were dramatically improved. The drug was well tolerated.

The trial was coordinated at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Multipurpose Arthritis and Musculoskeletal Diseases Center at the Children's Hospital Medical Center of Cincinnati, Ohio. It was performed by investigators in the Pediatric Rheumatology Collaborative Study Group. Its success is the culmination of many years of basic research supported by the NIAMS and other NIH components.

"These findings show a significant -- often profound -- improvement for most children with JRA when treated with Enbrel® compared to placebo," said Daniel J. Lovell, M.D., M.P.H., principal investigator and lead author. "Before Enbrel®, many children with severe JRA had a poor response to existing treatment options. Often, they would have to stop attending school. Now, there is hope for these children."

NIAMS Director Stephen I. Katz, M.D., Ph.D., stated, "Juvenile rheumatoid arthritis can be a devastating disease, not only to the children who have it, but to their families as well. We are pleased to have supported the b
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Contact: Janet Howard or Kelli Carrington
howardj@mail.nih.gov; carringk@mail.nih.gov
301-496-8190
NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases
16-Mar-2000


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