Prospective Open-Label Trial of Etanercept as Adjunctive Therapy for Kawasaki Disease

• Published in: The Journal of pediatrics Vol. 157; no. 6; pp. 960 - 966.e1
• Main Authors: Choueiter, Nadine F., Olson, Aaron K., Shen, Danny D., Portman, Michael A.
• Format: Journal Article
• Language: English
• Published: Maryland Heights, MO Mosby, Inc 01.12.2010; Elsevier
• Subjects: Biological and medical sciences; Child, Preschool; Etanercept; Female; General aspects; Humans; Immunoglobulin G - therapeutic use; Infant; Male; Medical sciences; Mucocutaneous Lymph Node Syndrome - drug therapy; Pediatrics; Prospective Studies; Receptors, Tumor Necrosis Factor - antagonists & inhibitors; Receptors, Tumor Necrosis Factor - therapeutic use; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; AAP; CRP; RCA; JIA; TNF-α; IVIG; KD; AHA; LAD; TB; C-reactive protein; Left anterior descending; Tumor necrosis factor –α; Intravenous immunoglobulin; American Academy of Pediatrics; Juvenile idiopathic arthritis; American Heart Association; Right coronary artery; Kawasaki disease; Tuberculosis; Kawasaki syndrome; Drug; Immunopathology; Pediatrics; Cytokine; Antipsoriatic agent; Adjuvant treatment; Autoimmune disease; Cardiovascular disease; Anti-Tumor Necrosis Factor-alpha; Vascular disease; Immunomodulator; Prospective; Vasculitis; Etanercept; Anticytokine; Systemic disease; Clinical trial; Antagonist; Antirheumatic agent; Fusion protein; Tumor necrosis factor α
• ISSN: 0022-3476; 1097-6833; 1097-6833
• DOI: 10.1016/j.jpeds.2010.06.014

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. 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. 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. Etanercept appears to be safe and well tolerated in children with KD. The data support performance of a placebo-controlled trial.