19 Apr 2026

Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease 가와사키병에 대한 보조적 프레드니솔론 투여의 무작위 배정 임상시험

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Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease

가와사키병에 대한 보조적 프레드니솔론 투여의 무작위 배정 임상시험

Authors: Siyuan Lin, M.D., Yuanchen He, M.Sc., Lan He, M.D., Yiling Liu, M.D., Fangjie Wang, M.D., Zhenyu Xiong, M.D., Yixiang Lin, M.D., +41 , for the Chinese Kawasaki Disease Collaboration Network*Author Info & Affiliations
Published April 15, 2026
N Engl J Med 2026;394:1480-1490
DOI: 10.1056/NEJMoa2511478
VOL. 394 NO. 15
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.)
Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease

가와사키병에 대한 보조적 프레드니솔론 투여의 무작위 배정 임상시험

 

Authors: Siyuan Lin, M.D., Yuanchen He, M.Sc., Lan He, M.D., Yiling Liu, M.D., Fangjie Wang, M.D., Zhenyu Xiong, M.D., Yixiang Lin, M.D., +41 , for the Chinese Kawasaki Disease Collaboration Network*Author Info & Affiliations
Published April 15, 2026
N Engl J Med 2026;394:1480-1490
DOI: 10.1056/NEJMoa2511478
VOL. 394 NO. 15
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.)

 

가와사키병에 대한 보조적 프레드니솔론 투여의 무작위 배정 임상시험

저자: Siyuan Lin, M.D., Yuanchen He, M.Sc., Lan He, M.D., Yiling Liu, M.D., Fangjie Wang, M.D., Zhenyu Xiong, M.D., Yixiang Lin, M.D., 외 41명 (Chinese Kawasaki Disease Collaboration Network 대표)* 저자 정보 및 소속
발행일: 2026년 4월 15일
N Engl J Med 2026;394:1480-1490
DOI: 10.1056/NEJMoa2511478
VOL. 394 NO. 15
Copyright © 2026
초록
배경
선별 과정을 거치지 않은 가와사키병 환자들의 초기 치료에 있어, 보조적 글루코코르티코이드 투여가 미치는 효과는 아직 알려져 있지 않습니다.
방법
중국에서 수행된 이번 다기관, 공개 라벨(open-label), 무작위 배정, 대조 임상시험에서, 연구진은 새로 가와사키병 진단을 받은 참가자들을 1:1 비율로 무작위 배정하여, ‘프레드니솔론 병용 표준 치료군’ 또는 ‘표준 치료 단독군’ 중 하나를 받도록 했습니다. 1차 평가변수는 발병 후 1개월 시점에 관상동맥 병변이 발생하는지 여부였습니다. (다중성(multiplicity)에 대한 보정이 적용되지 않은) 사전 지정된 주요 2차 평가변수에는 구조 요법(rescue therapy)의 시행 여부, 발열 지속 기간, C-반응성 단백(CRP) 수치의 변화, 그리고 관상동맥 z-점수(z-scores)의 변화가 포함되었습니다.

연구 요약
가와사키병에 대한 보조적 프레드니솔론 투여의 무작위 배정 임상시험

출처: NEJM 2026년 4월 16일자

 

결과
총 3,208명의 참가자가 무작위 배정 절차를 거쳤으며, 이 중 3,184명의 참가자를 대상으로 한 분석에서 870명(27.3%)에게서 연구 시작 시점(baseline)에 이미 관상동맥 병변이 발견되었습니다. 1개월 시점에, 프레드니솔론과 표준 치료를 병행한 참가자의 16.0%에서, 그리고 표준 치료만 받은 참가자의 13.8%에서 관상동맥 병변이 발견되었습니다(보정 위험 차이 1.1%포인트; 95% 신뢰구간 -1.0~3.4; P=0.31). 구조 요법은 프레드니솔론 병행 치료군 참가자의 4.6%와 표준 치료 단독군 참가자의 10.1%에서 시행되었습니다. 발열 지속 기간의 중앙값은 각 군에서 8.4시간과 13.2시간이었으며, 72시간 시점에서의 C-반응성 단백(CRP) 수치 감소 폭은 각각 리터당 67.5mg과 59.8mg이었습니다. 관상동맥 Z-점수의 감소 양상은 두 군 간에 유사했습니다. 3개월 시점에서의 관상동맥 병변 발생률은 프레드니솔론 병행 치료군에서 12.6%, 표준 치료 단독군에서 10.5%였습니다. 또한 관상동맥 병변이 진행된 참가자의 비율은 각 군에서 28.6%와 28.9%였으며, 중등도 내지 거대 관상동맥류의 발생률은 1.9%와 1.1%였습니다. 전반적인 이상 반응 발생률은 두 군 간에 유의미한 차이가 없었습니다.
결론
가와사키병의 표준 초기 치료에 프레드니솔론을 추가하는 것은 질환 발병 1개월 시점에서의 관상동맥 병변 발생률을 감소시키지 못했습니다. (자금 지원: 중국 의학과학원 의학과학 혁신 기금 및 중국 국가자연과학기금; ClinicalTrials.gov 등록 번호: NCT04078568)

Source; NEJM 4/162026

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