http://www.nlm.nih.gov/databases/alerts/enbrol.html
Clinical Alert: Enbrel Shown Safe, Effective in Children and Teenagers with Juvenile_rheumatoid_arthritis Clinical Alert: Enbrel Shown Safe, Effective in Children and Teenagers with Juvenile_rheumatoid_arthritis National Institute of Arthritis and Musculoskeletal and Skin_diseases (NIAMS) 17 March 2000 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_improved dramatically. The drug was_tolerated well. 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 basic research behind this drug that relieves so_much pain and reduces the amount of joint destruction.""Enbrel belongs to a new class of drug treatments called"biologic agents"that are_designed to interfere with the specific biological_process of a disease. Enbrel is a tumor_necrosis_factor (TNF) antagonist, a substance that blocks the action of TNF, a naturally occurring protein in the body that helps cause inflammation. It acts as a"sponge"to absorb TNF. The clinical trial adhered to the Food and Drug Administration's"Pediatric Rule, "which requires manufacturers of new drugs and biologic agents that will_be_used commonly for children to provide specific information about safe pediatric use. JRA is a type of arthritis that causes joint inflammation and stiffness for more_than six weeks beginning when the child is 16 years of_age or less. Inflammation causes redness, swelling, warmth and soreness in the joints, although many children with JRA do not complain of joint pain. Any joint can be_affected and inflammation may limit the mobility of affected joints. There_are three types of JRA: polyarticular (affecting five or more joints), pauciarticular (affecting four or fewer joints) and systemic, also called Still's_disease (joint swelling, fever, rash, and organ involvement). For more information on juvenile_rheumatoid_arthritis, and for a fact sheet on arthritis drugs, call 1-877-22-NIAMS, or visit the NIAMS web_site at http://www. nih. gov/niams/healthinfo. The American Juvenile Arthritis Organization, at http://www. arthritis. org/,can also provide information. The mission of the National Institute of Arthritis and Musculoskeletal and Skin_diseases (NIAMS) is to support research into the causes, treatment and prevention of arthritis and musculoskeletal and skin_diseases, the training of basic and clinical scientists to carry_out this research, and the dissemination of information on research progress in these diseases. For more information about NIAMS call our information clearinghouse at 1-877-22-NIAMS or visit the NIAMS web_site at http ://www. nih. gov/niams. Enbrel (etanercept) is a trademark of Immunex Corporation, which markets Enbrel in North_america with Wyeth-ayerst, a division of American Home_products Corporation. Manufactured by Immunex, Seattle, Wash. To interview Dr . Daniel Lovell, contact Jim Feuer, media relations manager, Children's Hospital Medical_center of Cincinnati at 513-636-4656. Reference Lovell D, Giannini, E, Reiff A, Cawkwell G, Silverman E, Nocton J, Stein L, Gedalia A, Ilowite N, Wallace C, Whitmore J, Finck B. Etanercept in children with polyarticular juvenile_rheumatoid_arthritis. NEJM 2000; 342: 763-9. U_s. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894 National_institutes_of_health, Department_of_health & Human Services Copyright, Privacy, Accessibility Last updated: 21 March 2000