Good disease control , with therapeutic escalation to achieve low disease activity , was recommended .
OBJECTIVE To develop treatment recommendations for children with juvenile idiopathic arthritis manifesting as non-systemic polyarthritis , sacroiliitis , or enthesitis .
Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis.
OBJECTIVE This study was undertaken to evaluate the long-term safety and effectiveness of etanercept alone or in combination with methotrexate ( MTX ) in children with selected categories of juvenile idiopathic arthritis ( JIA ) . METHODS Patients ages 2 - 18 years with rheumatoid factor (RF)-positive or RF-negative polyarthritis , systemic JIA , or extended oligoarthritis were eligible for the study . Patients received MTX alone ( > or = 10 mg/m(2)/week [ approximately 0.3 mg/kg/week ] , maximum dosage 1 mg/kg/week ) , etanercept alone ( 0.8 mg/kg/week , maximum dose 50 mg ) , or etanercept plus MTX for 3 years in an open-label , nonr and omized study . Safety was assessed by measuring rates of adverse events , and effectiveness was assessed using the physician 's global assessment of disease activity and the pediatric total joint assessment . RESULTS A total of 197 , 103 , and 294 patients were enrolled in the MTX , etanercept , and etanercept plus MTX groups , respectively . Exposure-adjusted rates of adverse events were similar among the 3 treatment groups ( 18.3 , 18.7 , and 21.6 per 100 patient-years in the MTX , etanercept , and etanercept plus MTX groups , respectively ) . Respective rates per 100 patient-years of serious adverse events ( 4.6 , 7.1 , and 6.0 ) and medically important infections ( 1.3 , 1.8 , and 2.1 ) were also similar among the 3 treatment groups . Scores for physician 's global assessment and total active joints improved from baseline , and improvement was maintained for the duration of the study . CONCLUSION These data confirm the findings of other long-term studies and suggest that etanercept or etanercept plus MTX has an acceptable safety and effectiveness profile in children with selected categories of JIA . Improvement was maintained for 3 years in those continuing to receive medication
Good disease control , with therapeutic escalation to achieve low disease activity , was recommended .
OBJECTIVE To develop treatment recommendations for children with juvenile idiopathic arthritis manifesting as non-systemic polyarthritis , sacroiliitis , or enthesitis .