The Arthritis Foundation estimates that nearly 50,000 children in the United States have some type of juvenile rheumatoid arthritis. After a six-month review, the U.S. Food and Drug Administration (FDA) has approved Enbrel, a rheumatoid arthritis drug, for use in children. According to the drug labeling, the new indication is defined as a "reduction in signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more [disease-modifying antirheumatic drugs]." The drug was first approved in late 1998 to treat moderate to severe rheumatoid arthritis in adults.
Immunex, the manufacturer of Enbrel, will collect data on the safety and efficacy of the drug in at least 500 patients with juvenile rheumatoid arthritis. The expected duration of the study will be a minimum of three years, according to an approval letter from the FDA for the new arthritis indication.
Previous labeling contained a summary of a trial of 69 patients with juvenile rheumatoid arthritis, but the product was not specifically indicated for use in children. The results of that trial are fully explained in the new labeling.
The new three-year study "will include detailed efficacy and safety data collection on 200 patients with more limited data collection in an additional 300 patients." The manufacturer will initiate the study or registry by April 1, 2000. More information on the study appears in the May 31, 1999 issue of "The Pink Sheet." Information can also be obtained on the FDA Web site at http://www. fda.gov.
COPYRIGHT 2000 American Academy of Family Physicians
COPYRIGHT 2000 Gale Group
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