Efficacy and safety of etanercept in children and adolescents aged > or = 8 years with severe plaque psoriasis.
Author(s): Landells I, Paller AS, Pariser D, Kricorian G, Foehl J, Molta C, Freundlich B
Affiliation(s): Nexus Clinical Research, St. John's, Newfoundland, Canada.
Publication date & source: 2010-05, Eur J Dermatol., 20(3):323-8. Epub 2010 Feb 25.
Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Etanercept, a fully human soluble tumor necrosis factor (TNF)-alpha receptor, is approved in Europe for treatment of severe plaque psoriasis in children > or = 8 years. The efficacy and safety of etanercept for this population was evaluated in a retrospective analysis of a previous study, which included 211 children (4-17 years) with psoriasis involving > or = 10% body surface area and Psoriasis Area and Severity Index (PASI) > or = 12. In this subanalysis, subjects aged 8-17 years received once-weekly subcutaneous etanercept 0.8 mg/kg (< or = 50 mg) or placebo in double-blind fashion for 12 weeks, followed by 24 weeks of open-label etanercept. Baseline demographics and disease characteristics were similar across treatment arms (etanercept n = 95, placebo n = 97). At week 12, 54.7% subjects receiving etanercept versus 11.3% receiving placebo achieved 75% or greater improvement in PASI (PASI 75) compared with baseline (p < 0.001). PASI 50, PASI 90, and static Physician Global Assessment of psoriasis followed a similar pattern (p < 0.001). Efficacy during the open-label phase was sustained through Week 36. Exposure-adjusted rates of adverse events for etanercept were similar or lower than those for placebo. No appreciable differences were noted in the efficacy and safety profiles between the subjects aged > or = 8 years in this analysis and those in the original study population aged 4-17 years. In conclusion, etanercept provided significant, sustained improvement in disease severity and was well tolerated in children > or = 8 years with severe plaque psoriasis.