Efficacy of primary treatment with immunoglobulin plus ciclosporin for prevention of coronary artery abnormalities in patients with Kawasaki disease predicted to be at increased risk of non-response to intravenous immunoglobulin (KAICA): a randomised controlled, open-label, blinded-endpoints, phase 3 trial.
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Hamada Hiromichi, Suzuki Hiroyuki, Onouchi Yoshihiro, Ebata Ryota, Terai Masaru, Fuse Shigeto, Okajima Yoshitomo, Kurotobi Shunji, Hirai Katsuki, Soga Takashi, Ishiguchi Yukiko, Okuma Yoshiaki, Takada Nobuyuki, Yanai Masaaki, Sato Junichi, Nakayashiro Mami, Ayusawa Mamoru, Yamamoto Eiichi, Nomura Yuichi, Hashimura Yuya, Ouchi Kazunobu, Masuda Hiroshi, Takatsuki Shinichi, Hirono Keiichi, Ariga Tadashi, Higaki Takashi, Otsuki Akio, Terauchi Moe, Aoyagi Reiko, Sato Takatoshi, Fujii Yasuhisa, Fujiwara Tadami, Hanaoka Hideki, Hata Akira, KAICA trial Investigators
Аннотация
METHODS: We did a randomised, open-label, blinded endpoints trial involving 22 hospitals in Japan between May 29, 2014, and Dec 27, 2016. Eligible patients predicted to be at higher risk for intravenous immunoglobulin (IVIG) resistance were randomly assigned to IVIG plus ciclosporin (5 mg/kg per day for 5 days; study treatment) or IVIG (conventional treatment) groups, stratified by risk score, age, and sex. The primary endpoint was incidence of coronary artery abnormalities using Japanese criteria during the 12-week trial, assessed in participants who received at least one dose of study drug and who visited the study institution at least once during treatment. This trial is registered to Center for Clinical Trials, Japan Medical Association, number JMA-IIA00174.
FINDINGS: We enrolled 175 participants. One patient withdrew consent after enrolment and was excluded and one patient (in the study treatment group) was excluded from analysis because of lost echocardiography data. Incidence of coronary artery abnormalities was lower in the study treatment group than in the conventional treatment group (12 [14%] of 86 patients vs 27 [31%] of 87 patients; risk ratio 0·46; 95% CI 0·25-0·86; p=0·010). No difference was found in the incidence of adverse events between the groups (9% vs 7%; p=0·78).
INTERPRETATION: Combined primary therapy with IVIG and ciclosporin was safe and effective for favourable coronary artery outcomes in Kawasaki disease patients who were predicted to be unresponsive to IVIG.
FUNDING: Japan Agency for Medical Research and Development (grant CCT-B-2503).