Safety and efficacy of long-term etanercept in the treatment of methotrexate-refractory polyarticular-course juvenile idiopathic arthritis in Japan

Mod Rheumatol. 2012 Sep;22(5):720-6. doi: 10.1007/s10165-011-0578-5. Epub 2012 Jan 4.

Abstract

Objectives: Previous short-term trials found etanercept (0.2 or 0.4 mg/kg) to be effective and well tolerated in Japanese children with juvenile idiopathic arthritis (JIA) who were intolerant/resistant to methotrexate. The aim of this study was to evaluate the long-term safety and efficacy of etanercept in Japanese children with JIA.

Methods: Patients (4-19 years) who received etanercept in one of three short-term studies continued onto this long-term open-label study.

Results: Of the 32 patients enrolled, 18 (56.3%) completed 192 weeks of the study and 14 (43.8%) were discontinued; 7 (21.9%) for patient refusal, 2 (6.3%) for adverse events (AEs), and 5 (15.6%) for lack of efficacy. All patients reported AEs; 31 (96.9%) reported infections and 6 (18.8%) reported serious AEs. Main efficacy assessments included change from baseline in the American College of Rheumatology Pediatric core components, including mean improvements from baseline in the physician global assessment (90.7%), patient/guardian global assessments (54.1%), Childhood Health Assessment Questionnaire (84.6%), and median improvements in C-reactive protein levels (92.7%). No unexpected safety results were reported, and early efficacy responses were sustained in the long term.

Conclusions: This study provides further evidence that etanercept is an effective therapeutic option for Japanese children with polyarticular-course JIA.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Antirheumatic Agents / adverse effects
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Juvenile / blood
  • Arthritis, Juvenile / drug therapy*
  • Arthritis, Juvenile / physiopathology
  • C-Reactive Protein / analysis
  • Child
  • Child, Preschool
  • Drug Resistance
  • Drug Substitution
  • Etanercept
  • Female
  • Health Status
  • Humans
  • Immunoglobulin G / adverse effects
  • Immunoglobulin G / therapeutic use*
  • Male
  • Methotrexate / therapeutic use*
  • Quality of Life
  • Receptors, Tumor Necrosis Factor / therapeutic use*
  • Treatment Outcome
  • Young Adult

Substances

  • Antirheumatic Agents
  • Immunoglobulin G
  • Receptors, Tumor Necrosis Factor
  • C-Reactive Protein
  • Etanercept
  • Methotrexate