Randomized trial of different initial intravenous immunoglobulin regimens in Kawasaki disease

Lan He, Fang Liu, Weili Yan, Min Huang, Meirong Huang, Lijian Xie, Ying Guo, Xinyi Xu, Chen Chu, Lin Wu, Xuecun Liang, Shuna Sun, Feng Wang, Lu Zhao, Quming Zhao, Xiaojing Ma, Liping Xie, Guoying Huang, Lan He, Fang Liu, Weili Yan, Min Huang, Meirong Huang, Lijian Xie, Ying Guo, Xinyi Xu, Chen Chu, Lin Wu, Xuecun Liang, Shuna Sun, Feng Wang, Lu Zhao, Quming Zhao, Xiaojing Ma, Liping Xie, Guoying Huang

Abstract

Background: We aimed to assess the efficacy of different initial intravenous immunoglobulin (IVIG) regimens in Kawasaki disease (KD) patients to find more cost-effective therapy options.

Methods: A multicenter, open-label, blind-endpoint randomized controlled trial was conducted from January 2014 to December 2015. Patients with KD, within 10 days of illness, were randomly assigned to receive different IVIG regimens (Group A, 2 g/kg once; Group B, 1 g/kg for 2 consecutive days; Group C, 1 g/kg once) and aspirin 30mg/kg/d. Primary outcomes included hours to defervescence and development of coronary artery lesions during the study period. Major secondary outcomes included total fever days, total dose of IVIG, changes of laboratory data, length of stay, and hospitalization expenses. (ClinicalTrials.gov: NCT02439996).

Results: A total of 404 patients underwent randomization. No difference was found in the outcomes of defervescence among three groups at 6, 12, 24, and 36 hours after completion of initial IVIG infusion. There were no differences in the incidence of coronary artery lesions during the study period (at week 2, month 1, month 3, and month 6 of illness), changes of laboratory data, total fever days, and length of stay. Group C patients had the lowest total dose of IVIG (mean: 1.2 vs 2.2 vs 2.1 g/kg; P < 0.001) and hospitalization expenses (mean: 8443.8 vs 10798.4 vs 11011.4 Chinese Yuan; P < 0.001) than other two groups.

Conclusions: A single dose of 1g/kg IVIG is a low-cost treatment with the same efficacy as 2 g/kg IVIG and can be an option for the initial therapy of KD patients.

Keywords: coronary aneurysm; cost-benefit analysis; immunoglobulins; intravenous; mucocutaneous lymph node syndrome; treatment outcome.

Conflict of interest statement

The authors declare no conflict of interest.

© 2021 The Authors. Pediatrics International published by John Wiley & Sons Australia, Ltd on behalf of Japan Pediatric Society.

Figures

Fig. 1
Fig. 1
Enrollment and randomization. IVIG, intravenous immunoglobulin; KD, Kawasaki disease.

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