Prospective open-label trial of etanercept as adjunctive therapy for kawasaki disease

Nadine F. Choueiter, Aaron K. Olson, Danny D. Shen, Michael A. Portman

Research output: Contribution to journalArticle

58 Citations (Scopus)

Abstract

Objective: To determine the safety and pharmacokinetics of etanercept (Amgen, Thousand Oaks, California) a tumor necrosis factor-α receptor blocker, in children with acute Kawasaki disease (KD). Standard therapy of acute KD includes intravenous immunoglobulin (IVIG) and high-dose aspirin, but a substantial number of patients are refractory and require additional treatment. Tumor necrosis factor-α levels are elevated in children with KD, suggesting a role for etanercept in treatment. Study design: We performed a prospective open-label trial of etanercept in patients with KD (age range, 6 months-5 years; n = 17) meeting clinical criteria and with fever ≤10 days. All received IVIG and high-dose aspirin. They received etanercept immediately after IVIG infusion and then weekly two times. For the initial safety evaluation, the first 5 patients received 0.4 mg/kg/dose. Subsequent subjects received 0.8 mg/kg/dose. Results: Fifteen patients completed the study. The pharmacokinetics were similar to that in older children in published series. No serious adverse events related to etanercept occurred. No patient demonstrated prolonged or recrudescent fever requiring re-treatment with IVIG. No patient showed an increase in coronary artery diameter or new coronary artery dilation/cardiac dysfunction. Conclusion: Etanercept appears to be safe and well tolerated in children with KD. The data support performance of a placebo-controlled trial.

Original languageEnglish (US)
JournalJournal of Pediatrics
Volume157
Issue number6
DOIs
StatePublished - Dec 2010
Externally publishedYes

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Mucocutaneous Lymph Node Syndrome
Intravenous Immunoglobulins
Acute Disease
Aspirin
Coronary Vessels
Fever
Therapeutics
Pharmacokinetics
Safety
Tumor Necrosis Factor Receptors
Intravenous Infusions
Etanercept
Dilatation
Tumor Necrosis Factor-alpha
Placebos

Keywords

  • AAP
  • AHA
  • American Academy of Pediatrics
  • American Heart Association
  • C-reactive protein
  • CRP
  • Intravenous immunoglobulin
  • IVIG
  • JIA
  • Juvenile idiopathic arthritis
  • Kawasaki disease
  • KD
  • LAD
  • Left anterior descending
  • RCA
  • Right coronary artery
  • TB
  • Tuberculosis

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Prospective open-label trial of etanercept as adjunctive therapy for kawasaki disease. / Choueiter, Nadine F.; Olson, Aaron K.; Shen, Danny D.; Portman, Michael A.

In: Journal of Pediatrics, Vol. 157, No. 6, 12.2010.

Research output: Contribution to journalArticle

Choueiter, Nadine F. ; Olson, Aaron K. ; Shen, Danny D. ; Portman, Michael A. / Prospective open-label trial of etanercept as adjunctive therapy for kawasaki disease. In: Journal of Pediatrics. 2010 ; Vol. 157, No. 6.
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AB - Objective: To determine the safety and pharmacokinetics of etanercept (Amgen, Thousand Oaks, California) a tumor necrosis factor-α receptor blocker, in children with acute Kawasaki disease (KD). Standard therapy of acute KD includes intravenous immunoglobulin (IVIG) and high-dose aspirin, but a substantial number of patients are refractory and require additional treatment. Tumor necrosis factor-α levels are elevated in children with KD, suggesting a role for etanercept in treatment. Study design: We performed a prospective open-label trial of etanercept in patients with KD (age range, 6 months-5 years; n = 17) meeting clinical criteria and with fever ≤10 days. All received IVIG and high-dose aspirin. They received etanercept immediately after IVIG infusion and then weekly two times. For the initial safety evaluation, the first 5 patients received 0.4 mg/kg/dose. Subsequent subjects received 0.8 mg/kg/dose. Results: Fifteen patients completed the study. The pharmacokinetics were similar to that in older children in published series. No serious adverse events related to etanercept occurred. No patient demonstrated prolonged or recrudescent fever requiring re-treatment with IVIG. No patient showed an increase in coronary artery diameter or new coronary artery dilation/cardiac dysfunction. Conclusion: Etanercept appears to be safe and well tolerated in children with KD. The data support performance of a placebo-controlled trial.

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