Key result
Adjunctive prednisolone fails to reduce coronary artery aneurysms in Kawasaki disease.
Why the study?
Despite IVIG treatment, coronary artery aneurysm rates remain high in Europe and North America, leaving uncertain whether adjunctive prednisolone reduces aneurysms in unselected European children with Kawasaki disease.
Does adjunctive prednisolone reduce coronary artery aneurysms in unselected European children with Kawasaki disease?
RCT (n=103)
Open-label, blinded endpoint assessed
1:1 using a computer-generated minimisation algorithm
Yes
Does adjunctive prednisolone reduce coronary artery aneurysms in unselected European children with Kawasaki disease?
Adjunctive prednisolone did not reduce coronary artery aneurysms in unselected European children with Kawasaki disease, but it did reduce the need for treatment escalation and associated costs.
Background: Kawasaki disease (KD) is a childhood vasculitis affecting medium-sized arteries, particularly the coronary arteries. Despite treatment with intravenous immunoglobulin (IVIG), coronary artery aneurysm (CAA) rates remain high in Europe and North America. The KD-CAAP trial evaluated whether adjunctive prednisolone reduces CAA in unselected European children with KD. Methods: This multicentre, randomised, open-label, blinded endpoint-assessed, superiority trial (ISRCTN71987471) enrolled children aged 30 days to 16 years across 59 centres in 12 European countries. Participants were randomised 1:1 to oral prednisolone (2 mg/kg/day) plus IVIG (2 g/kg) and aspirin (experimental group); or IVIG and aspirin (control group), stratified by age (<1 vs ≥1 year), sex and country. Co-primary outcomes were: CAA within 12 weeks and mean maximum coronary artery z-score across weeks 1-6, analysed using intention-to-treat. Findings: Between Jan 2021-July 2024, 103 children (58% male; median age 2 years) were randomised: 50 to experimental and 53 to control groups. All children received IVIG + aspirin; fewer experimental participants received a second IVIG dose [9 (18%) vs 20 (38%) control, p = 0.021] or rescue therapy [8 (16%) vs 17 (32%), respectively, p = 0.044]. CAA occurred in 12/50 (24%) experimental vs 12/53 (23%) control participants (adjusted risk difference +1.1% (95% credibility interval -13.8%-16.1%), with 45% probability of benefit. There was no evidence of difference in mean maximum coronary z-scores over weeks 1-6 (mean 0.6 (95% confidence interval 0.4-0.9) vs 0.7 (0.4-0.9); adjusted difference -0.0; 95% confidence interval -0.2 to +0.2; p = 0.72). CAA developed in 6/12 (50%) infants <1 year. Serious Adverse Events occurred in 7 (14%) experimental vs 3 (6%) control participants (p = 0.19). Costs were significantly lower in the experimental group due to less IVIG use over 12 weeks. Interpretation: Prednisolone reduced treatment escalation, with potential health economic benefits, but did not reduce CAA in unselected European children with KD. CAA rates remained high, particularly in infants.
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Eleftheriou et al. (2026) conducted an RCT in Kawasaki disease (n=103). Prednisolone plus IVIG and aspirin vs. IVIG and aspirin was evaluated on Coronary artery aneurysms (CAA) within 12 weeks (adjusted risk difference +1.1%, 95% CI -13.8 to 16.1, p=0.87). Adjunctive prednisolone did not reduce the incidence of coronary artery aneurysms compared to standard therapy with IVIG and aspirin in unselected European children with Kawasaki disease.
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