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

Am Heart J. 2011 Mar;161(3):494-9. doi: 10.1016/j.ahj.2010.12.003.

Abstract

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 α 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 α antagonism by etanercept.

Trial registration: ClinicalTrials.gov NCT00841789.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Coronary Vessels / pathology
  • Dilatation, Pathologic
  • Endpoint Determination
  • Etanercept
  • Humans
  • Immunoglobulin G / administration & dosage
  • Immunoglobulin G / therapeutic use*
  • Immunoglobulins, Intravenous / therapeutic use
  • Immunologic Factors / therapeutic use
  • Receptors, Tumor Necrosis Factor / administration & dosage
  • Receptors, Tumor Necrosis Factor / antagonists & inhibitors*
  • Receptors, Tumor Necrosis Factor / therapeutic use
  • Research Design

Substances

  • Immunoglobulin G
  • Immunoglobulins, Intravenous
  • Immunologic Factors
  • Receptors, Tumor Necrosis Factor
  • Etanercept

Associated data

  • ClinicalTrials.gov/NCT00841789