Original ArticleEvaluation of Kawasaki Disease Risk-Scoring Systems for Intravenous Immunoglobulin Resistance
Section snippets
Methods
We enrolled patients in a randomized, double-blind, placebo-controlled trial of pulsed corticosteroid therapy for primary treatment of KD from December 2002 to December 2004 at 8 clinical centers in North America. The entry criteria, methods, and results of the trial have been published.8 Enrolled patients met modified American Heart Association criteria for KD and were between days 4 and 10 of illness.9 The study was conducted in accordance with institutional review board approval at each
Results
Median time from fever onset to enrollment was 6 days (interquartile range, 6 to 8 days), and the median age of the subjects was 2.9 years (IQR, 1.5 to 4.7 years). Fourteen percent of the subjects were Asian. IVIG re-treatment was administered to 27 of the 198 subjects (14%). Subjects re-treated with IVIG, compared with subjects who were not re-treated, were similar in age but were more likely to be male (82% versus 60%, P = .03) and, in univariate analysis of baseline laboratory variables (
Discussion
With the dataset of the Pediatric Heart Network’s randomized, placebo-blind trial of pulsed corticosteroids for primary therapy for KD, we evaluated the performance of 3 published risk scoring systems for prediction of IVIG resistance, derived from the data of Japanese populations.1, 2, 3 The 3 scoring systems were developed with data from patients who did not receive primary steroid therapy. We therefore performed our analyses both in the entire trial cohort and within the group that received
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Supported by U01 grants from the National Heart, Lung, and Blood Institute (HL068269, HL068270, HL068279, HL068281, HL068285, HL068292, HL068290, and HL068288). The authors declare no conflicts of interest.
Registered with clinicaltrials.gov: NCT00132080.
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List of members of the Pediatric Heart Network Investigators is available at www.jpeds.com (Appendix).