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| |  ACR: Enbrel (Etanercept) Tolerated and Effective in Children Under Four with Juvenile Rheumatoid Arthritis By Bruce Sylvester Special to DG News SAN FRANCISCO, CA -- November 15, 2001 -- Enbrel (etanercept) appears to be well tolerated, safe, and effective in some children with juvenile rheumatoid arthritis (JRA) under the age of four. "In this group, there appear to be no adverse effects in small children who were started on Enbrel. We found that no children developed any infections requiring hospitalisation, and we found that in some children there was significant improvement after starting Enbrel," Deborah Rothman, PhD, lead researcher and director of pediatrics and rheumatology at Shriner's Hospital in Springfield, Massachusetts, told Doctor's Guide. She presented her findings on November 14th at the American College of Rheumatology annual meeting in San Francisco, California. Enbrel has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of JRA in children older than age four. However, many children with severe disease are younger than this. Researchers sent a questionnaire to pediatric rheumatologists to determine if Enbrel is being used in children less than age four, whether there have been any adverse effects, and their clinical response. A total of 16 patients were reported, 12 with systemic-onset JRA (S-JRA) and four with polyarticular JRA (Poly-JRA). Detailed information is available on 14 of 16 patients. The average age (months ± SD) that etanercept was started was 25.8 ± 8.9 (range six to 40). All but one child were on methotrexate, all were on glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs), and, in addition two of the children were on hydroxychloroquine, two were on cyclosporine, and one was on azathioprine. All children were started on Enbrel because of poor clinical response to their medication regime and/or unacceptable steroid toxicity. The dose was 4 mg/kg subcutaneously twice weekly. The mean duration of etanercept therapy was 12.6 ± 5.8 months (range six to 20). No serious adverse events occurred. One child developed a presumed viral upper respiratory infection and subsequent disease flare, one child with a prior history of urinary tract infections developed one, and one child developed diarrhea but only after both cyclosporine and a homeopathic medication were started. There were no reports of any haematologic abnormalities. There was clinical improvement in 10 patients (eight with S-JRA and two with Poly-JRA), based on ability to taper other medications, resuming or starting ambulation (three children), and improvement of the joint exam. Prednisone was discontinued in six children. Three children are now on etanercept as their only medication. Four children -- three with S-JRA and one with Poly-JRA -- have shown little or no improvement with etanercept therapy. "There have been no other studies of this drug with children of this age. I was pleased that we did not see any toxicity that required stopping use of the drug. No children needed to be discontinued because of any adverse drug effect," Dr. Rothman said.
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