Etanercept as adjunctive treatment for acute Kawasaki disease: study design and rationale.

Author(s): Portman MA, Olson A, Soriano B, Dahdah N, Williams R, Kirkpatrick E

Affiliation(s): Seattle Children's Hospital, WA 98101, USA. michael.portman@seattlechildrens.org

Publication date & source: 2011-03, Am Heart J., 161(3):494-9.

Publication type: Randomized Controlled Trial; Research Support, N.I.H., Extramural

BACKGROUND: Kawasaki disease (KD) is a multisystem vasculitis affecting coronary arteries in children. Patients, refractory to standard treatment with intravenous immunoglobulin and aspirin, show higher rates of coronary artery dilation. Early tumor necrosis factor alpha receptor antagonism in KD may provide effective adjunctive therapy. STUDY DESIGN: The EATAK trial is a multicenter, double-blind, randomized, and placebo-controlled trial intended to assess the efficacy of etanercept in reducing the intravenous immunoglobulin refractory rate during treatment of acute KD. Each arm will enroll 110 patients who will receive 3 doses of study drug over 2 weeks in conjunction with standard therapy. Coronary artery dilation parameters will serve as secondary end points. DISCUSSION: The EATAK trial will test a new paradigm for treatment of acute KD involving tumor necrosis factor alpha antagonism by etanercept. Copyright (c) 2011 Mosby, Inc. All rights reserved.