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| |  ACR: Prolonged Efficacy With Enbrel (Etanercept) in Refractory Juvenile Ankylosing Spondylitis By Bruce Sylvester Special to DG News SAN FRANCISCO, CA -- November 16, 2001 -- Etanercept treatment resulted in a very dramatic and rapid therapeutic response in eight children with refractory juvenile ankylosing spondylitis (JAS)-- with respect to erythrocyte sedimentation rate (ESR), active joint count, increased hemoglobin and decreased morning stiffness. Researchers reported their findings at the American College of Rheumatology annual meeting in San Francisco, California. "These are children who had profound disease at onset. They were failing all therapies," Michael Henrickson, MD, lead investigator and clinical director of Valley Children's Hospital in Fresno, California, told Doctor's Guide. "They had a lot of functional limitations, symptoms and laboratory parameters as well as physical evidence of marked disease. Some of these young patients had had joint replacements and disease for up to 16 years. It was the worst of the worst in this population." The researchers investigated whether Enbrel could sustain long-term efficacy in a cohort of eight children with JAS and prior disease-modifying anti-rheumatic drug (DMARD) failure. There were seven males and one female in the cohort. Average age was 15.9 years (range 12-25) with JAS onset at mean age of 11.5 years (range 8-16). After enrollment, the children were followed for a mean of 15.4 months. Six of eight children were HLA-B27 positive; two out of eight, including the female, were HLA-B27 negative. Average disease duration prior to Enbrel therapy was 4.5 years (range 1.2-17.5). Prior to Enbrel treatment, eight children had persistent synovitis and an elevated ESR, five had radiographic changes, and six had anemia. Enbrel was administered at 0.2-0.8 mg/kg subcutaneously twice weekly; three patients had a dose increase while on the study. Four of eight children received concomitant methotrexate (MTX) during the study. Results at 12 months treatment with etanercept show no morning stiffness (p<0.103), an active joint count of 0.3 (p<0.001), mean hemoglobin level of 13.9 g/dL (p<0.001), and a erythrocyte sedimentation rate of 11.4 mm/h (p<0.0001). "We found that they had tremendous results very quickly on Enbrel, within a two-month period. This is the first time that we looked at the effect of this therapy on JAS, but it mirrors studies of the use of etanercept in other idiopathic and inflammatory conditions," Dr. Henrickson said.
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