Abstract
Introduction: Etanercept, a soluble TNF receptor, is beneficial when given as an adjunct to IVIg to children with acute Kawasaki disease (KD) and coronary artery (CA) involvement. A multi-center phase III trial, Etanercept as Adjunctive Treatment for Acute Kawasaki Disease (EATAK), showed that this TNF antagonist prevented progression of CA dilation over 6 weeks after acute KD. Aims: This study is aimed to test the long-term benefit of Etanercept in improving CA outcome. Methods: Patients enrolled in the placebo controlled double blind EATAK trial from 3 institutions (Seattle, Montreal, Bronx) who had CA dilation (z≥2.5) on initial presentation were included in this study ( n =40). The percent reduction in the size of affected vessels from echocardiogram at presentation to mid-year (4-8 months), 1-year (9-23 months) and ≥2 years after diagnosis were analyzed, and two-tailed t test used to compare Etanercept (0.8 mg/kg x3 doses) and placebo ( n =18) groups. Results: Both groups showed mean reduction (20%) in coronary artery diameter over a 2 year period (Figure). However, patients treated with Etanercept had accelerated and significantly greater improvement in diameter of affected vessels in the first 6 months after diagnosis [22% ( n =25) vs. 6.8% ( n =13), p =0.015]. The trend continued at 1-year follow up ([24.1% ( n =35) vs. 17.5% ( n =27), p =0.24], and by 2 years both groups showed similar overall change [19.6% ( n =31) vs. 24.7% ( n =24), p =0. 43]. Conclusions: Etanercept as an adjunct treatment to IVIg in acute KD with CA involvement accelerates regression of CA dilation over at least a 6 month period after acute inflammation. Etanercept is a potent anti-inflammatory agent that has both early and long-term benefit in CA remodeling in KD. Acceleration of CA healing by Etanercept may provide long term coronary artery benefit.
Published Version
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