Abstract

We compared the efficacy and safety of infliximab with intravenous immunoglobulin (IVIG), a standard therapy, in a phase 3 trial (NCT01596335) for Japanese patients with Kawasaki disease (KD) showing persistent fever after initial IVIG. Patients with initial IVIG-refractory KD, aged 1–10 years, received a single dose of IV infliximab 5 mg/kg or IV polyethylene glycol-treated human immunoglobulin (VGIH) 2 g/kg on day 0. Primary outcome was defervescence rate within 48 h after the start of treatment. Safety was evaluated through day 56. Overall, 31 patients were randomized (infliximab, n = 16; VGIH, n = 15); 31.3% and 60.0% patients discontinued due to worsening KD. Defervescence rate within 48 h was greater with infliximab (76.7%) than VGIH (37.0%) (p = 0.023), and defervescence was achieved earlier with infliximab (p = 0.0072). Coronary artery lesions occurred in 1 (6.3%) and 3 (20.0%) patients receiving infliximab and VGIH, respectively, up to day 21. Adverse events occurred in 15 (93.8%) and 15 (100.0%) patients in the infliximab and VGIH groups, respectively. No serious adverse events in the infliximab group and one in the VGIH group were observed. Infliximab improved the defervescence rate within 48 h and time to defervescence versus standard therapy, and was well tolerated in patients with IVIG-refractory KD.

Details

Title
Infliximab versus intravenous immunoglobulin for refractory Kawasaki disease: a phase 3, randomized, open-label, active-controlled, parallel-group, multicenter trial
Author
Mori, Masaaki 1 ; Hara, Takuma 2 ; Kikuchi, Masako 3 ; Shimizu, Hiroyuki 4 ; Miyamoto, Tomoyuki 5 ; Iwashima, Satoru 6   VIAFID ORCID Logo  ; Oonishi, Tatsuya 7 ; Hashimoto, Kunio 8 ; Kobayashi, Norimoto 9 ; Waki, Kenji 10 ; Suzuki, Yasuo 11 ; Otsubo, Yoshikazu 12 ; Yamada, Hiroshi 13 ; Ishikawa, Chikao 13 ; Kato, Taichi 14 ; Fuse, Shigeto 15 

1  Yokohama City University Medical Center, Yokohama, Japan; Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University, Tokyo, Japan 
2  Yokohama City University Medical Center, Yokohama, Japan; Department of Pediatrics, Hara Children’s Clinic, Tokorozawa, Japan 
3  Department of Pediatrics, Yokohama City University Hospital, Yokohama, Japan 
4  Children’s Medical Center, Yokohama City University Medical Center, Yokohama, Japan 
5  Department of Pediatrics, Yokosuka General Hospital Uwamachi, Yokosuka, Japan 
6  Hamamatsu University School of Medicine, Hamamatsu, Japan; Department of Pediatrics, Chutoen General Medical Center, Kakegawa, Japan 
7  Department of Pediatrics, National Hospital Organization Shikoku Medical Center for Children and Adults, Zentsuji, Japan 
8  Department of Pediatrics, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan 
9  Department of Pediatrics, Shinsyu University School of Medicine, Matsumoto, Japan 
10  Department of Pediatrics, Kurashiki Central Hospital, Kurashiki, Japan 
11  Department of Pediatrics, Yamaguchi University Graduate School of Medicine, Ube, Japan 
12  Department of Pediatrics, Sasebo City General Hospital, Sasebo, Japan 
13  Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan 
14  Department of Pediatrics, Nagoya University Hospital, Nagoya, Japan 
15  Department of Pediatrics, NTT Sapporo Medical Center, Sapporo, Japan 
Pages
1-10
Publication year
2018
Publication date
Jan 2018
Publisher
Nature Publishing Group
e-ISSN
20452322
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1038/s41598-017-18387-7
ProQuest document ID
1992989568
Copyright
© 2018. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.