Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms (CAA) in Kawasaki disease (KD): the KD-CAA prevention (KD-CAAP) trial
In brief
Prednisolone adds no benefit to coronary aneurysm prevention in Kawasaki disease
In a European trial of 103 children, coronary artery aneurysms occurred in 24% of those receiving prednisolone plus IVIG and aspirin versus 23% with IVIG and aspirin alone, showing no reduction. Steroid use cut the need for repeat IVIG and lowered costs, but serious adverse events were slightly more common, and aneurysm rates remained high, especially in infants.
- Journal
- EClinicalMedicine (Q1)
- Published
- 13 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Despina Eleftheriou, Roisin Connon, Robert Tulloh, Neil Martin, Filip Kucera, Georgi Christov, et al.
- PMID
- 42518942
- DOI
- 10.1016/j.eclinm.2026.104044
Why clinicians should know about it
- Picked for Rheumatology (top studies of the week, 2 August 2026): Adjunctive prednisolone reduces treatment escalation in Kawasaki disease
- Picked for Pediatrics and Child Health (top studies of the week, 2 August 2026): KD‑CAAP RCT of corticosteroids plus IVIG vs IVIG alone for
Abstract
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. FUNDING: Innovative Medicines Initiative grant 777389.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.