IVIG for Kawasaki Disease
Trial question
Is IVIG alone noninferior to IVIG plus high-dose aspirin for the reduction of coronary artery lesions in children with Kawasaki disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 134
134 patients (52 female, 82 male).
Inclusion criteria: children, aged < 6 years, diagnosed with Kawasaki disease.
Key exclusion criteria: fever for > 10 days; history of prior treatment with corticosteroids or biologics; inability to take aspirin; afebrile prior to enrolment; coronary artery lesion prior to enrolment; severe concomitant medical disorders; suspected to have an infectious disease.
Interventions
N=65 IVIG alone (at a dose of 2 g/kg as a single infusion, followed by low-dose aspirin of 3-5 mg/kg/day for 6 weeks).
N=69 IVIG plus aspirin (IVIG 2 g/kg as a single infusion plus aspirin 80-100 mg/kg/day until fever subsided for 48 hours, followed by low-dose aspirin of 3-5 mg/kg/day for 6 weeks).
Primary outcome
Coronary artery lesions at 6 weeks
12.3%
15.9%
15.9 %
11.9 %
8.0 %
4.0 %
0.0 %
Intravenous immunoglobulin
alone
Intravenous immunoglobulin plus
aspirin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in coronary artery lesions at 6 weeks (12.3% vs. 15.9%; ARD -3.6, 97.5% CI -8.1 to 100).
Secondary outcomes
No significant difference in coronary artery lesion rate of left coronary artery at 6 weeks (7.7% vs. 10.1%; ARD -2.4, 97.5% CI -7.1 to 100).
No significant difference in coronary artery lesion rate of right coronary artery at 6 weeks (7.7% vs. 5.8%; AD 1.9%, 97.5% CI -100 to 10).
Conclusion
In children, aged < 6 years, diagnosed with Kawasaki disease, IVIG alone was noninferior to IVIG plus aspirin with respect to coronary artery lesions at 6 weeks.
Reference
Ho-Chang Kuo, Ming-Chih Lin, Chung-Chih Kao et al. Intravenous Immunoglobulin Alone for Coronary Artery Lesion Treatment of Kawasaki Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e253063.
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