Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease

BACKGROUND: The effect of adjunctive glucocorticoids in the primary treatment of Kawasaki disease in unselected patients remains unknown. METHODS: In this multicenter, open-label, randomized, controlled trial in China, we assigned participants with newly diagnosed Kawasaki disease in a 1:1 ratio to receive prednisolone plus standard treatment or standard treatment alone. The primary outcome was the occurrence of coronary-artery lesions at 1 month after illness onset. Prespecified key secondary outcomes, for which analyses were not controlled for multiplicity, included receipt of rescue therapy, duration of fever, change in the C-reactive protein (CRP) level, and changes in coronary-artery z scores. RESULTS: A total of 3208 participants underwent randomization, with coronary-artery lesions detected at baseline in 870 of 3184 participants (27.3%). At 1 month, coronary-artery lesions were detected in 16.0% of the participants receiving prednisolone plus standard treatment and in 13.8% of those receiving standard treatment alone (adjusted risk difference, 1.1 percentage points; 95% confidence interval, -1.0 to 3.4; P = 0.31). Rescue therapy was used in 4.6% of the participants receiving prednisolone plus standard therapy and in 10.1% of those receiving standard treatment alone; the median duration of fever was 8.4 hours and 13.2 hours, respectively, and the reductions in the C-reactive protein level at 72 hours were 67.5 mg per liter and 59.8 mg per liter. Decreases in coronary-artery z scores were similar in the two groups. At 3 months, the incidence of coronary-artery lesions was 12.6% with prednisolone plus standard therapy and 10.5% with standard treatment alone; the percentage of participants with progression of coronary-artery lesions was 28.6% and 28.9%, respectively, and the incidence of medium-to-giant coronary-artery aneurysms was 1.9% and 1.1%. The overall incidence of adverse events did not differ significantly between the two groups. CONCLUSIONS: The addition of prednisolone to standard primary treatment for Kawasaki disease did not reduce the incidence of coronary-artery lesions at 1 month after illness onset. (Funded by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences and the National Natural Science Foundation of China; ClinicalTrials.gov number, NCT04078568.).

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Publication Details

Journal
New England Journal of Medicine
Published
2026-04-15
DOI
https://doi.org/10.1056/nejmoa2511478
Citations
3
Primary Topic
Kawasaki Disease and Coronary Complications
Type
article
Field-Weighted Citation Impact
72.20

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article

Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease

Rongzhou Wu, 朱华, Xianmei Huang, Xiaoli An et al.
3 citations
New England Journal of Medicine
Kawasaki Disease and Coronary Complications
72.20
article

Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease

Rongzhou Wu, 朱华, Xianmei Huang, Xiaoli An, Zhenyu Xiong, Yalan Dou, Qin Huang, Weili Yan, Xiaoyan Liu, Siyuan Lin, Ce Wang, Zipu Li, Lan Ye, Yi-Xiang Wang, wennan he, Hua Peng, Qian Peng, Silin Pan, Xuecun Liang, Yixiang Lin, Quming Zhao, Yuanzheng Zheng, G Y Huang, L He, Lu Zhao, Yuanchen He, Cuifen Zhao, Lijun Qin, Xiaohui Liu, Yan Li, Duolao Wang, Ping Huang, Fangjie Wang, Xiaobi Huang, Fang Liu, Jingwei Sun, Shuna Sun, Feng Wang, Xiangyu Dong, Yiling Liu, Xuehua He, Haitao Lv, Yaofei Hu, Shubin Lin, Yanling Liao, Chen Chu, Yinyin Cao, Jinhua Piao
article en
3 citations

Abstract

BACKGROUND: The effect of adjunctive glucocorticoids in the primary treatment of Kawasaki disease in unselected patients remains unknown. METHODS: In this multicenter, open-label, randomized, controlled trial in China, we assigned participants with newly diagnosed Kawasaki disease in a 1:1 ratio to receive prednisolone plus standard treatment or standard treatment alone. The primary outcome was the occurrence of coronary-artery lesions at 1 month after illness onset. Prespecified key secondary outcomes, for which analyses were not controlled for multiplicity, included receipt of rescue therapy, duration of fever, change in the C-reactive protein (CRP) level, and changes in coronary-artery z scores. RESULTS: A total of 3208 participants underwent randomization, with coronary-artery lesions detected at baseline in 870 of 3184 participants (27.3%). At 1 month, coronary-artery lesions were detected in 16.0% of the participants receiving prednisolone plus standard treatment and in 13.8% of those receiving standard treatment alone (adjusted risk difference, 1.1 percentage points; 95% confidence interval, -1.0 to 3.4; P = 0.31). Rescue therapy was used in 4.6% of the participants receiving prednisolone plus standard therapy and in 10.1% of those receiving standard treatment alone; the median duration of fever was 8.4 hours and 13.2 hours, respectively, and the reductions in the C-reactive protein level at 72 hours were 67.5 mg per liter and 59.8 mg per liter. Decreases in coronary-artery z scores were similar in the two groups. At 3 months, the incidence of coronary-artery lesions was 12.6% with prednisolone plus standard therapy and 10.5% with standard treatment alone; the percentage of participants with progression of coronary-artery lesions was 28.6% and 28.9%, respectively, and the incidence of medium-to-giant coronary-artery aneurysms was 1.9% and 1.1%. The overall incidence of adverse events did not differ significantly between the two groups. CONCLUSIONS: The addition of prednisolone to standard primary treatment for Kawasaki disease did not reduce the incidence of coronary-artery lesions at 1 month after illness onset. (Funded by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences and the National Natural Science Foundation of China; ClinicalTrials.gov number, NCT04078568.).

New England Journal of MedicineVol. 394(15)
Qingdao University (CN), Hubei University of Medicine (CN), Union Hospital (HK), Sun Yat-sen University (CN), Bengbu Medical College (CN), Hunan Normal University (CN), Xuzhou Medical College (CN), Jilin University (CN), Liverpool School of Tropical Medicine (GB), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Wenzhou Medical University (CN), Soochow University (CN), China International Science and Technology Cooperation (CN), Chengdu Women's and Children's Central Hospital (CN), Liuzhou Maternal and Child Health Hospital (CN), Sun Yat-sen Memorial Hospital (CN), Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University (CN), Zhengzhou Children's Hospital (CN), Taihe Hospital (CN), Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (CN), Lanzhou University Second Hospital (CN), Inner Mongolia People's Hospital (CN), First Hospital of Jilin University (CN), Changchun Children's Hospital (CN), Kaifeng City Children's Hospital (CN), Xuzhou Children Hospital (CN), Third Affiliated Hospital of Zhengzhou University (CN), Early Intervention Foundation (GB), Jiangxi Provincial Children's Hospital (CN), Anhui Provincial Children's Hospital (CN), Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine (CN), First Affiliated Hospital of Bengbu Medical College (CN), Children's Hospital of Fudan University (CN), Qilu Hospital of Shandong University (CN), Children’s Hospital of Fudan University Xiamen Branch (CN), Qingdao Women and Children's Hospital (CN), Huazhong University of Science and Technology (CN), Lanzhou University (CN), Chongqing Medical University (CN), China Medical University (CN), Guangzhou Medical University (CN)
National Natural Science Foundation of China, Chinese Academy of Medical Sciences
Openalex Percentile: Top 0%
Kawasaki Disease and Coronary Complications
72.20
DOISourceOpenAlex
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