Abstract | BACKGROUND: Although Kawasaki disease (KD) is the most common cause of acquired heart disease in children and may result in coronary artery aneurysms (CAA) with an attendant risk of myocardial infarction, there is no recommended therapy to halt progression of arterial wall damage and prevent aneurysm formation in the acute phase of the vasculitis. While intravenous immunoglobulin ( IVIG) reduces the risk of CAA, up to 20% of KD patients are IVIG resistant and have a higher risk for developing CAA. The IL-1 pro-inflammatory pathway is upregulated in children with acute KD and plays a critical role in the experimental animal model of KD. Thus, IL-1 is a logical therapeutic target. OBJECTIVES: The goal of this study is to determine the safety, tolerability, pharmacokinetics, and immunomodulatory effects of anakinra, a recombinant human IL-1 receptor antagonist, in acute KD patients with coronary artery abnormalities on the baseline echocardiogram. DESIGN: CONCLUSION: The safety and tolerability of blocking both IL-1α and Il-1β by anakinra will be evaluated as a strategy to prevent or attenuate coronary artery damage in infants and children with acute KD. TRIAL REGISTRATION: Clinical Trials.gov # NCT02179853, registered June 28, 2014.
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Authors | Adriana H Tremoulet, Sonia Jain, Susan Kim, Jane Newburger, Moshe Arditi, Alessandra Franco, Brookie Best, Jane C Burns |
Journal | Contemporary clinical trials
(Contemp Clin Trials)
Vol. 48
Pg. 70-5
(05 2016)
ISSN: 1559-2030 [Electronic] United States |
PMID | 27080929
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2016 Elsevier Inc. All rights reserved. |
Chemical References |
- Antirheumatic Agents
- Immunoglobulins, Intravenous
- Immunologic Factors
- Interleukin 1 Receptor Antagonist Protein
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Topics |
- Antirheumatic Agents
(therapeutic use)
- Child, Preschool
- Coronary Aneurysm
(etiology, prevention & control)
- Coronary Vessels
(pathology)
- Humans
- Immunoglobulins, Intravenous
(therapeutic use)
- Immunologic Factors
(therapeutic use)
- Infant
- Interleukin 1 Receptor Antagonist Protein
(therapeutic use)
- Mucocutaneous Lymph Node Syndrome
(complications, drug therapy, pathology)
- Organ Size
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