title: Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis.
abstract: BACKGROUND
  There are no systemic therapies approved in the United States to treat pediatric psoriasis.
  
  
  OBJECTIVE
  We sought to evaluate long-term safety and efficacy of etanercept in children and adolescents with moderate to severe plaque psoriasis.
  
  
  METHODS
  This 5-year, open-label extension study enrolled patients aged 4 to 17 years who had participated in a 48-week parent study. End points included occurrence of adverse events (AEs) and serious AEs including infections, and rates of 75% and 90% improvement in Psoriasis Area and Severity Index score and clear/almost clear on static physician global assessment.
  
  
  RESULTS
  Of 182 patients enrolled, 181 received etanercept and 69 completed 264 weeks. Through week 264, 161 (89.0%) patients reported an AE, most commonly upper respiratory tract infection (37.6%), nasopharyngitis (26.0%), and headache (21.5%). Seven patients reported 8 serious AEs; only 1 (cellulitis) was considered treatment-related. No cases of opportunistic infections or malignancy were reported. Rates of 75% improvement in Psoriasis Area and Severity Index score (∼ 60%-70%) and 90% improvement in Psoriasis Area and Severity Index score (∼ 30%-40%) and static physician global assessment status clear/almost clear (∼ 40%-50%) were maintained through week 264.
  
  
  CONCLUSIONS
  The number of patients remaining on study at week 264 was small.
  
  
  CONCLUSIONS
  Etanercept in pediatric patients was generally well tolerated and efficacy was maintained in those who remained in the study for up to 264 weeks.
authors.affiliation: Northwestern University Feinberg School of Medicine and the Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois. Electronic address: apaller@northwestern.edu.
authors.forename: Amy S
authors.initials: AS
authors.lastname: Paller
authors.affiliation: Cardinal Glennon Children's Hospital and Saint Louis University, St Louis, Missouri.
authors.forename: Elaine C
authors.initials: EC
authors.lastname: Siegfried
authors.affiliation: Eastern Virginia Medical School and Virginia Clinical Research Inc.
authors.forename: David M
authors.initials: DM
authors.lastname: Pariser
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Kara Creamer
authors.initials: KC
authors.lastname: Rice
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Mona
authors.initials: M
authors.lastname: Trivedi
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Jan
authors.initials: J
authors.lastname: Iles
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: David H
authors.initials: DH
authors.lastname: Collier
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Greg
authors.initials: G
authors.lastname: Kricorian
authors.affiliation: Dalhousie University, Halifax, Nova Scotia, Canada.
authors.forename: Richard G
authors.initials: RG
authors.lastname: Langley
mesh_terms: D000293:Adolescent; D002481:Cellulitis / Q000139:chemically induced; D002648:Child; D002675:Child, Preschool; D000068800:Etanercept / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D009304:Nasopharyngitis / Q000139:chemically induced; D011565:Psoriasis / Q000188:drug therapy*; D012141:Respiratory Tract Infections / Q000139:chemically induced; D012720:Severity of Illness Index; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D000068800:Etanercept
keywords: etanercept; long-term safety; open-label; pediatric population; plaque psoriasis