Prospective Open-Label Trial of Etanercept as Adjunctive Therapy for Kawasaki Disease - 07/03/14
, Aaron K. Olson, MD a, , Danny D. Shen, PhD b, Michael A. Portman, MD a, ⁎ 
Reprint requests: Michael A. Portman, MD, Director of Pediatric Cardiovascular Research, Seattle Children’s Hospital Research Institute, 1900 9th Ave, C9S-918 Seattle WA 98101-1304.Abstract |
Objective |
To determine the safety and pharmacokinetics of etanercept (Amgen, Thousand Oaks, California) a tumor necrosis factor-⍺ 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-⍺ 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.
Le texte complet de cet article est disponible en PDF.Mots-clés : AAP, AHA, CRP, IVIG, JIA, KD, LAD, RCA, TB, TNF-⍺
Plan
| The study was funded by the NIH funded University of Washington Clinical and Translational Science Award Grant 1ULI RR025014-01. M.P received funding and the study drug from Amgen for this investigator initiated and sponsored study. Amgen did not participate in the study design, the collection, analysis, interpretation of data, the writing of the report; or the decision to submit the manuscript for publication. The other authors declare no conflict of interest. |
Vol 157 - N° 6
P. 960 - décembre 2010 Retour au numéro
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