Polyarticular-course juvenile rheumatoid arthritis (JRA): For reducing signs and symptoms of moderately to severe active polyarticular-course JRA in patients who have had an inadequate response to 1 or more disease - modifying antirheumatic drugs (DMARD).
Doses higher than 25 mg twice weekly are not recommended.
Children (4 to 17 years of age): The recommended dose of etanercept for children 4 to 17 years of age with active polyarticular-course JRA is 0.4 mg/kg (upto a maximum of 25 mg/dose). Given SC twice weekly 72 to 96 hours apart. Glucocorticoids, NSAIDS, or analgesics may be continued during treatment with etanercept.
Etanercept has been studied in approximately 1200 patients with RA, followed for up to 36 months and in 157 patients with psoriatic arthritis for 6 months. The proportion of patients who discontinued treatment because of adverse events was approximately 4% in etanercept and placebo treated patients. The vast majority of these patients were treated with recommended dose 25 mg SC twice daily.
In controlled trials of RA and psoriatic arthritis, rates of serious adverse events were seen at a frequency of approximately 5% among etanercept - and control -treated patients. Among RA patients in placebo-controlled, active-controlled, and open-label trials of etanercept, malignancies and infections were the most common serious adverse events observed. ...