Long-term etanercept in pediatric patients with plaque psoriasis.
Author(s): Paller AS, Siegfried EC, Eichenfield LF, Pariser D, Langley RG, Creamer K, Kricorian G
Affiliation(s): Children's Memorial Hospital and Northwestern University Medical School, Chicago, Illinois, USA. email@example.com
Publication date & source: 2010-11, J Am Acad Dermatol., 63(5):762-8. Epub 2010 Jun 3.
Publication type: Clinical Trial; Multicenter Study; Research Support, Non-U.S. Gov't
BACKGROUND: No systemic therapies are approved by the US Food and Drug Administration for the treatment of psoriasis in children and adolescents. OBJECTIVE: We sought to evaluate the long-term safety and efficacy of etanercept in pediatric patients (aged 4-17 years) with moderate to severe plaque psoriasis. METHODS: Patients who completed or received substantial treatment benefit in a 48-week, randomized, double-blind, placebo-controlled study (N = 211) evaluating the efficacy and safety of once-weekly etanercept (0.8 mg/kg) were enrolled in this 264-week open-label extension study. The primary end point was the occurrence of adverse events. Secondary end points included Psoriasis Area and Severity Index 50%, 75%, and 90% responses compared with baseline; static Physician Global Assessment; and clear and clear/almost clear static Physician Global Assessment status. Results from a 96-week interim analysis are presented. RESULTS: Of 182 enrolled patients, 181 received treatment and 140 (76.9%) completed week 96. A total of 145 patients (80.1%) reported adverse events; 5 serious adverse events occurred in 3 patients, none of which were treatment related. Observed Psoriasis Area and Severity Index 50% (89%), 75% (61%), and 90% (30%) responses compared with baseline at week 96 were similar to those observed in the double-blind trial. The static Physician Global Assessment was maintained through week 96, when 47% of patients achieved clear/almost clear status. LIMITATIONS: This is an interim analysis from an open-label study. CONCLUSION: Extended treatment with etanercept in pediatric patients with moderate to severe plaque psoriasis was generally well tolerated, and efficacy was maintained through 96 weeks. Copyright (c) 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.