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

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ELEFTHERIOU, Despina, CONNON, Roisin, TULLOH, Robert, MARTIN, Neil, KUCERA, Filip, CHRISTOV, Georgi, KAHN, Robin, MOSSBERG, Maria, NORDENHÄLL, Charlotta, BAILHACHE, Marion, PALMU, Sauli, WEBB, Carlotta, MCCROSSAN, Brian, HERBERG, Jethro, MORAES, Yolanda Collaco, MCCORMACK, Rachael, STONE, John, HUNTER, Rachael, WALKER, Ann Sarah, BROGAN, Paul, MERIDA MORILLAS, Marta, PURSELL, Molly, PAPADOPOULOU, Charalampia, ALOBAIDI, Muthana, MORAITIS, Elena, WALSH, Jo, MCLELLAN, Kirsty, ILINA, Maria, JANSEN, Marc, IRO, Mildred, DEWALS, Wendy, LAAN, Mari, VAN ONZENOORT, Lonneke, LANGER, Daniel, COLES, Will, PAULUS, Stephan, WILLIAMS, Eleri, NÚÑEZ-CUADROS, Esmeralda, ANTÓN, Jordi, HERTTING, Olof, DE SOMER, Lien, BERG, Stefan, PANZER, Joseph, MEERSCHAUT, Ilse, JÕGI, Piia, HUET, Frédéric, JEZIORSKI, Eric, VON BOTH, Ulrich, JAKOB, Andre, KRICKAU, Tobias, ROSINA, Silvia, SIMONINI, Gabrielle, TADDIO, Andrea, FERNANDEZ COOKE, Elisa, MILLER, Owen, SEFI, Elinor, LEVIN, Michael, SWALLOW, Veronica, WAN, Mandy, STANDING, Joseph, PANG, Kimberley and WYNCOLL, James (2026). 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. eClinicalMedicine, 97: 104044. [Article]

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Abstract
h4>Background:</h4> 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. <h4>Methods:</h4> 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. <h4>Findings:</h4> 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. <h4>Interpretation:</h4> 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. <h4>Funding:</h4> Innovative Medicines Initiative grant 777389.
More Information
Official URL:
https://doi.org/10.1016/j.eclinm.2026.104044
Uncontrolled Keywords:
3202 Clinical sciences; 4203 Health services and systems; 4206 Public health

Identifiers

Identification Number:
10.1016/j.eclinm.2026.104044
ORCID for Despina Eleftheriou: ORCID iD orcid.org/0000-0002-5312-2269
ORCID for Georgi Christov: ORCID iD orcid.org/0000-0002-9875-9482
ORCID for Robin Kahn: ORCID iD orcid.org/0000-0002-3167-1179
ORCID for Sauli Palmu: ORCID iD orcid.org/0000-0003-3270-7660
ORCID for Rachael Hunter: ORCID iD orcid.org/0000-0002-7447-8934
ORCID for Veronica Swallow: ORCID iD orcid.org/0000-0001-8504-4704

Library

Publisher:
Elsevier BV
Item Type:
Article
SWORD Depositor:
Symplectic Elements
Depositing User:
Symplectic Elements
Date record made live:
18 Aug 2026 12:51
Last Modified:
18 Aug 2026 13:00
Date of first compliant deposit:
18 August 2026
Date of first compliant Open Access:
18 August 2026
Version of first compliant deposit:
Version of Record
ISSN:
2589-5370
Volume:
97
URI:
https://shura.shu.ac.uk/id/eprint/37852
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