Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease

The effect of adjunctive glucocorticoids in the primary treatment of Kawasaki disease in unselected patients remains unknown.

In this multicenter, open-label, randomized, controlled trial in China, we assigned participants with newly diagnosed Kawasaki disease in a 1:1 ratio to receive prednisolone plus standard treatment or standard treatment alone. The primary outcome was the occurrence of coronary-artery lesions at 1 month after illness onset. Prespecified key secondary outcomes, for which analyses were not controlled for multiplicity, included receipt of rescue therapy, duration of fever, change in the C-reactive protein (CRP) level, and changes in coronary-artery z scores.