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


METHODS
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.


CONCLUSIONS
Etanercept appears to be safe and well tolerated in children with KD. The data support performance of a placebo-controlled trial.
Choueiter
Nadine F
NF
Division of Cardiology, Department of Pediatrics, University of Washington and Center for Developmental Therapeutics, Seattle Children's Hospital and Research Institute, Seattle, WA, USA.
Olson
Aaron K
AK
Shen
Danny D
DD
Portman
Michael A
MA
D002675:Child, Preschool; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007223:Infant; D008297:Male; D009080:Mucocutaneous Lymph Node Syndrome / Q000188:drug therapy*; D011446:Prospective Studies; D018124:Receptors, Tumor Necrosis Factor / Q000037:antagonists & inhibitors* / Q000627:therapeutic use
D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept