In children with Kawasaki disease, treatment with intravenous immunoglobulin (IVIG) and aspirin reduces the development of coronary artery lesions but does not fully prevent this complication in all patients. Current guidelines recommend adding glucocorticoids to this standard primary treatment for children at high risk of resistance to IVIG treatment (a known risk factor for coronary artery lesions); however, whether this approach benefits unselected patients remains controversial. The results of a phase III, open-label, randomized trial in China now suggest that adjunctive prednisolone does not reduce the incidence of coronary artery lesions within 1 month of disease onset in unselected patients.

The trial included 3,208 children with newly diagnosed Kawasaki disease from 28 sites across China, irrespective of risk of IVIG resistance or coronary artery status. Participants were randomly allocated to receive either standard treatment (IVIG and oral aspirin) or standard treatment plus prednisolone.