title: Long-term etanercept in pediatric patients with plaque psoriasis.
abstract: 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.
  
  
  CONCLUSIONS
  This is an interim analysis from an open-label study.
  
  
  CONCLUSIONS
  Extended treatment with etanercept in pediatric patients with moderate to severe plaque psoriasis was generally well tolerated, and efficacy was maintained through 96 weeks.
authors.affiliation: Children's Memorial Hospital and Northwestern University Medical School, Chicago, Illinois, USA. apaller@northwestern.edu
authors.forename: Amy S
authors.initials: AS
authors.lastname: Paller
authors.forename: Elaine C
authors.initials: EC
authors.lastname: Siegfried
authors.forename: Lawrence F
authors.initials: LF
authors.lastname: Eichenfield
authors.forename: David
authors.initials: D
authors.lastname: Pariser
authors.forename: Richard G
authors.initials: RG
authors.lastname: Langley
authors.forename: Kara
authors.initials: K
authors.lastname: Creamer
authors.forename: Greg
authors.initials: G
authors.lastname: Kricorian
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000009:adverse effects*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology*; D016032:Randomized Controlled Trials as Topic; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage; D012720:Severity of Illness Index; D012867:Skin / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept