Hiroshi Masuda1, Tohru Kobayashi2, Akira Hachiya3, Yasutaka Nakashima4, Hiroyuki Shimizu5, Tomo Nozawa6, Yoshihito Ogihara7, Shuichi Ito8, Shinichi Takatsuki9, Nobuyuki Katsumata10, Yasuo Suzuki11, Satoshi Takenaka12, Keiichi Hirono13, Tomio Kobayashi14, Hiroshi Suzuki15, Eisuke Suganuma16, Kei Takahashi17, Tsutomu Saji18. 1. Department of General Pediatrics and Interdisciplinary Medicine, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan; Department of Pediatrics, Graduate School of Medicine, Yokohama City University, Yokohama, Kanagawa, Japan. 2. Division of Clinical Research Planning, Department of Development Strategy, Center for Clinical Research and Development, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan. Electronic address: torukoba@nifty.com. 3. Department of Pediatrics, Shinshu University School of Medicine, Matsumoto, Nagano, Japan. 4. Department of Pediatrics, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Fukuoka, Japan. 5. Children's Medical Center, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan. 6. Department of Pediatrics, Graduate School of Medicine, Yokohama City University, Yokohama, Kanagawa, Japan. 7. Department of Pediatrics, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan. 8. Department of Pediatrics, Graduate School of Medicine, Yokohama City University, Yokohama, Kanagawa, Japan; Division of Pediatric Nephrology and Rheumatology, National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan. 9. Department of Pediatrics, Toho University, Medical Center Omori Hospital, Ota-ku, Tokyo, Japan. 10. Department of Pediatrics, Faculty of Medicine University of Yamanashi, Chuo, Yamanashi, Japan. 11. Department of Pediatrics, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan. 12. Department of Pediatrics, Japan Community Healthcare Organization (JCHO), Kyusyu Hospital, Kitakyushu, Fukuoka, Japan. 13. Department of Pediatrics, Graduate School of Medicine, University of Toyama, Toyama, Toyama, Japan. 14. Division of Cardiology, Gunma Children's Medical Center, Shibukawa, Gunma, Japan. 15. Department of Pediatrics, Yamagata University School of Medicine, Yamagata, Yamagata, Japan. 16. Division of Infectious Diseases and Immunology, Saitama Children's Medical Center, Saitama, Saitama, Japan. 17. Department of Pathology, Toho University Ohashi Medical Center, Shibuya-ku, Tokyo, Japan. 18. Advanced and Integrated Cardiovascular Research Course in the Young and Adolescence, Ota-ku, Toho University, Tokyo, Japan.
Abstract
OBJECTIVE: To assess the safety and efficacy of infliximab (IFX) for the treatment of patients with Kawasaki disease (KD). STUDY DESIGN: This was a nationwide survey of 274 Japanese institutions exploring how IFX was used to treat patients with KD. The patients' sex, age, treatment course, pre- and post-IFX therapy blood test results, coronary artery lesions (CALs), and adverse events (AEs) were evaluated. RESULTS: We analyzed 434 patients with KD who received IFX between March 2005 and November 2014. The median age at onset was 33 months (range 1-138), and 66 patients (15.2%) were under 1 year old. In all cases, IFX was administered as additional treatment. The median days of illness at the initiation of IFX was 9 days. In 275 patients (63.4%), IFX was administered as third-line treatment, and in 106 patients (24.4%), IFX was administered as fourth-line treatment. Single dose IFX 5 mg/kg was administered to 412 patients (94.9%). After IFX, 363 patients (83.6%) became afebrile within 2 days, and the white blood cell count, percentage of neutrophils, and serum C-reactive protein levels significantly decreased (P < .001), although 119 patients (27.4%) received additional treatment. Before IFX, 132 patients (30.4%) had already developed CALs. In patients without CALs before IFX, 31 patients (10.3%) newly developed CAL after IFX, whereas 32 patients (24.2%) with CAL before IFX showed increased CAL severity. Eighty AEs were observed in 69 patients (15.9%); however, serious AEs were few and reversible. CONCLUSIONS: IFX might be an effective and tolerable treatment for refractory KD.
OBJECTIVE: To assess the safety and efficacy of infliximab (IFX) for the treatment of patients with Kawasaki disease (KD). STUDY DESIGN: This was a nationwide survey of 274 Japanese institutions exploring how IFX was used to treat patients with KD. The patients' sex, age, treatment course, pre- and post-IFX therapy blood test results, coronary artery lesions (CALs), and adverse events (AEs) were evaluated. RESULTS: We analyzed 434 patients with KD who received IFX between March 2005 and November 2014. The median age at onset was 33 months (range 1-138), and 66 patients (15.2%) were under 1 year old. In all cases, IFX was administered as additional treatment. The median days of illness at the initiation of IFX was 9 days. In 275 patients (63.4%), IFX was administered as third-line treatment, and in 106 patients (24.4%), IFX was administered as fourth-line treatment. Single dose IFX 5 mg/kg was administered to 412 patients (94.9%). After IFX, 363 patients (83.6%) became afebrile within 2 days, and the white blood cell count, percentage of neutrophils, and serum C-reactive protein levels significantly decreased (P < .001), although 119 patients (27.4%) received additional treatment. Before IFX, 132 patients (30.4%) had already developed CALs. In patients without CALs before IFX, 31 patients (10.3%) newly developed CAL after IFX, whereas 32 patients (24.2%) with CAL before IFX showed increased CAL severity. Eighty AEs were observed in 69 patients (15.9%); however, serious AEs were few and reversible. CONCLUSIONS:IFX might be an effective and tolerable treatment for refractory KD.