Long-term etanercept in pediatric patients with plaque psoriasis.
Author(s): Paller AS, Siegfried EC, Eichenfield LF, Pariser D, Langley RG, Creamer K,
Affiliation(s): Children's Memorial Hospital and Northwestern University Medical School, Chicago,
Illinois, USA. email@example.com
Publication date & source: 2010, J Am Acad Dermatol. , 63(5):762-8
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.