Pharmacokinetics, Immunogenicity, and Efficacy of Etanercept in Pediatric Patients With Moderate to Severe Plaque Psoriasis

Etanercepthas been recently approved in the United States for the treatment of moderate to severe plaque psoriasisin patients aged 4–17 years. The objective of this study was to characterize etanerceptpharmacokinetics, immunogenicity, and efficacy in pediatric patients. Data from a phase 3 study and open-label extension study were analyzed. Etanerceptserum concentrations in pediatric patients receiving etanercept0.8 mg/kg (maximum, 50 mg) weekly were compared with adult psoriasispatients and pediatric patients with juvenile idiopathic arthritis (JIA) who received etanercept0.4 mg/kg twice weekly. The developments of antietanercept antibodies and efficacy based on the Psoriasis Areaand Severity Indexwere evaluated. Steady-state trough etanerceptconcentrations were similar across visits from weeks 12–48, between patients aged 4–11 and 12–17 years, between pediatric and adult psoriasispatients, and between pediatric patients with psoriasisor JIA. Etanerceptserum concentrations and safety profiles were similar in patients with (15.9%) and without antietanercept antibodies. Dosing used in the study provided similar exposures and efficacy across ranges of weight and body mass index. Pharmacokinetic, immunogenicity, and efficacy data support 0.8 mg/kg (maximum, 50 mg) weekly dosing of etanerceptin patients aged 4–17 years.