Comparison of the Safety and Effectiveness of 5％ Immunoglobulin and 10％ Immunoglobulin for the Treatment of Kawasaki Disease

Abstract

Background: Intravenous immunoglobulin (IVIG) is the mainstay of initial treatment for Kawasaki disease (KD). Previously, 5 immunoglobulin was used for the treatment of patients with KD; however, a 10 immunoglobulin preparation has recently become available. Purpose: To analyze the safety and e ectiveness of treatment with 10 immunoglobulin in patients with KD. Additionally, we sought to determine whether it was possible to shorten the interval between the initial IVIG dose and the second IVIG dose, among the patients who did not respond to the initial IVIG dose (non-responders) in the 10 IVIG group. Methods: We retrospectively compared the clinical ndings of 103 patients who were administered 5 IVIG, and 60 patients who were administered 10 IVIG between January 2015 and May 2019. Results: e clinical pro les were not signi cantly di erent between the 5 and 10 groups. A total of 31 (30) patients in the 5 group, and 20 (33) patients in the 10 group, were nonresponsive to the initial IVIG dose, although these di erences were not signi cant (p 0.727). e interval between the initial IVIG dose and the second IVIG dose among the non-responders was signi cantly shorter in the 10 IVIG group than the 5 IVIG group (48.8 vs 45.4 hours, p 0.004). Only one patient in the 5 group developed coronary artery lesions, and no serious adverse events were observed. Conclusion: Results showed that 10 immunoglobulin is as safe and e ective as 5 immunoglobulin for the treatment of patients with KD, and can provide additional early treatment for non-responders to the initial IVIG dose.

Low‐ versus high‐concentration intravenous immunoglobulin for children with Kawasaki disease in the acute phase

“…[14][15][16][17][18][19] Previous small studies on KD have also shown no significant difference in the proportion with CAAs between 5% and 10% IVIG for patients with acute-phase KD. 2,4 In this study, 10% IVIG was shown to increase the proportion of IVIG resistance in patients with acute KD. According to the 2012 Japanese KD guidelines, the observation period for KD is 24 hours after the completion of the first IVIG dose.…”

“…Numerous studies have shown insignificant differences in outcomes between 5% and 10% IVIG for multifocal motor neuropathy, chronic inflammatory demyelinating polyradiculoneuropathy, primary immunodeficiency, and vesiculobullous autoimmune diseases 14‐19 . Previous small studies on KD have also shown no significant difference in the proportion with CAAs between 5% and 10% IVIG for patients with acute‐phase KD 2,4 …”

“…Several previous studies have shown that halving the dose and duration of treatment for patients with KD in the acute phase may lead to earlier detection of IVIG resistance because of reduced volume load and shorter treatment duration. [2][3][4] Additionally, more intense treatments can be used to suppress inflammation faster in patients with KD in the acute phase. No studies have evaluated the proportion of patients with IVIG resistance or coronary artery abnormalities (CAAs), length of stay, medical costs, or complications by different concentrations of IVIG.…”

“…In the United States, 10% IVIG preparations are already mainstream. Several previous studies have shown that halving the dose and duration of treatment for patients with KD in the acute phase may lead to earlier detection of IVIG resistance because of reduced volume load and shorter treatment duration 2‐4 . Additionally, more intense treatments can be used to suppress inflammation faster in patients with KD in the acute phase.…”

Comparative effectiveness of two intravenous immunoglobulin products in children with Kawasaki disease, a nationwide cohort study

“…Thus, the difference in infusion time by different concentration cannot explain the phenomenon we observed in this study. A small retrospective cohort and another nationwide inpatient database study in Japan observed no significant difference between 5 and 10% IVIG for the treatment of patients with acute-phase KD 28 , 29 . Based on aforementioned, we therefore infer that the difference in concentration of TBSF and Privigen is not responsible for clinical differences.…”