title: Safety and efficacy of etanercept in a cohort of patients with juvenile idiopathic arthritis under 4 years of age.
abstract: OBJECTIVE
  To evaluate safety, tolerability, and efficacy of etanercept in a cohort of patients with juvenile idiopathic arthritis (JIA) under 4 years of age.
  
  
  METHODS
  Data were collected at every visit during treatment with etanercept in 25 children who began treatment at a mean age of 3 years (range 18-48 months). Safety endpoints included the incidence of any adverse events. Efficacy endpoints included the American College of Rheumatology (ACR) Pediatric 30, 50, and 70 criteria for improvement.
  
  
  RESULTS
  Data from 25 patients with JIA treated with etanercept for a mean period of 23 months were analyzed. All patients received concomitant medications: 24 methotrexate, 3 cyclosporin A, and 10 corticosteroids. After the first 6 months of treatment, 15 (71.4%) patients achieved an ACR Pedi30 response and at the last observation 20 (80%) achieved ACR Pedi30. ACR Pedi50 and 70 responses were, respectively, 62% and 43% at 6 months and 72% and 64% at the last followup. Five patients (20%) discontinued etanercept for lack of efficacy. Two (8%) developed adverse events, both primary varicella zoster virus (VZV) infections (both not vaccinated). One was hospitalized because of a necrotizing fasciitis secondary to VZV infection. No cases of tuberculosis, opportunistic infections, or malignancies were reported.
  
  
  CONCLUSIONS
  In our cohort of patients etanercept proved to be safe and efficacious in the majority of children. The response in toddlers was similar to that in older children. We observed only 1 case of severe infection that required hospitalization and stopped treatment temporarily.
authors.affiliation: Division of Rheumatology, Department of Pediatric Medicine, Ospedale Pediatrico Bambino GesùIRCCS, Rome, Italy. claudia.bracaglia@opbg.net
authors.forename: Claudia
authors.initials: C
authors.lastname: Bracaglia
authors.forename: Paola S
authors.initials: PS
authors.lastname: Buonuomo
authors.forename: Alberto E
authors.initials: AE
authors.lastname: Tozzi
authors.forename: Manuela
authors.initials: M
authors.lastname: Pardeo
authors.forename: Rebecca
authors.initials: R
authors.lastname: Nicolai
authors.forename: Andrea
authors.initials: A
authors.lastname: Campana
authors.forename: Antonella
authors.initials: A
authors.lastname: Insalaco
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Cortis
authors.forename: Fabrizio
authors.initials: F
authors.lastname: DE Benedetti
mesh_terms: D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D002644:Chickenpox / Q000209:etiology / Q000276:immunology; D002675:Child, Preschool; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006304:Health Status; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D007596:Joints / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D016059:Range of Motion, Articular; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D020127:Recovery of Function; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept; D008727:Methotrexate