title: Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of up to 8 years of etanercept treatment in patients with polyarticular-course juvenile rheumatoid arthritis (JRA).
  
  
  METHODS
  Patients with JRA who previously participated in a randomized controlled trial (RCT) of etanercept were eligible to receive etanercept in a long-term open-label extension (OLE) trial. Safety end points included the incidences of serious adverse events (SAEs), medically important infections (MIIs), and death. Efficacy end points included the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, Pedi 70, Pedi 90, and Pedi 100 criteria for improvement.
  
  
  RESULTS
  Of the 69 patients originally enrolled in the RCT, 58 (84%) participated in the OLE, for a total of 318 patient-years of etanercept exposure. A total of 42 of the 58 patients (72%) entered the fourth year of continuous etanercept treatment, and 26 patients (45%) entered the eighth year. Sixteen patients (23% of those entering the RCT) reported 39 SAEs. The overall rate of SAEs (0.12 per patient-year) did not increase with long-term exposure to etanercept. The rate of MIIs (0.03 per patient-year) remained low; 1 new MII was reported in patients with > or =5 years of etanercept exposure. No cases of tuberculosis, opportunistic infections, malignancies, lymphomas, lupus, demyelinating disorders, or deaths were reported. An ACR Pedi 70 response or higher was achieved by 100% of patients with 8 years of data (11 of 11) and by 61% of patients according to the last observation carried forward data (28 of 46).
  
  
  CONCLUSIONS
  These data suggest that the acceptable safety profile of etanercept therapy is maintained for up to 8 years in this population of JRA patients. Improvements in the signs and symptoms of JRA were also maintained for up to 8 years.
authors.affiliation: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, USA. Daniel.Lovell@cchmc.org
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Lovell
authors.forename: Andreas
authors.initials: A
authors.lastname: Reiff
authors.forename: Norman T
authors.initials: NT
authors.lastname: Ilowite
authors.forename: Carol A
authors.initials: CA
authors.lastname: Wallace
authors.forename: Yun
authors.initials: Y
authors.lastname: Chon
authors.forename: Shao-Lee
authors.initials: SL
authors.lastname: Lin
authors.forename: Scott W
authors.initials: SW
authors.lastname: Baumgartner
authors.forename: Edward H
authors.initials: EH
authors.lastname: Giannini
mesh_terms: D000293:Adolescent; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept