Safety and efficacy of etanercept in children with juvenile idiopathic arthritis below the age of 4 years

Rheumatol Int. 2008 Aug;28(10):1031-4. doi: 10.1007/s00296-008-0563-2. Epub 2008 Mar 28.


Little is known about the safety and efficacy of etanercept in children below the age of 4 years. Twenty-five patients with juvenile idiopathic arthritis (JIA) below the age of 4 years, who received etanercept, were documented in the German JIA Etanercept Registry. Patients with the nonsystemic JIA disease-subtype responded more frequently to treatment with etanercept than systemic onset patients. At last observation, two (20%) of the nonsystemic patients did not reach a PedACR 30 response, while six (40%) of the systemic onset patients did not respond to the therapy. Complete resolution of symptoms was observed in two (20%) nonsystemic and in five (33%) systemic onset patients with JIA. Tolerability was good with only two infections occurring in the total patients group. Patients with JIA below the age of 4 years, with a methotrexate-resistant disease course, would also benefit from treatment with etanercept, showing a good tolerability. The restriction to children older than 4 years appears to be artificial without any good rationale.

MeSH terms

  • Age Factors
  • Antirheumatic Agents / administration & dosage*
  • Antirheumatic Agents / adverse effects
  • Arthritis, Juvenile / drug therapy*
  • Child, Preschool
  • Drug Therapy, Combination
  • Etanercept
  • Female
  • Glucocorticoids / administration & dosage
  • Humans
  • Immunoglobulin G / administration & dosage*
  • Immunoglobulin G / adverse effects
  • Infant
  • Male
  • Methotrexate / administration & dosage
  • Prednisone / administration & dosage
  • Receptors, Tumor Necrosis Factor / administration & dosage*
  • Registries / statistics & numerical data
  • Treatment Outcome


  • Antirheumatic Agents
  • Glucocorticoids
  • Immunoglobulin G
  • Receptors, Tumor Necrosis Factor
  • Etanercept
  • Prednisone
  • Methotrexate