Adjunctive prednisolone does not reduce coronary artery lesions in Kawasaki disease

1. In this randomized controlled trial involving children with newly diagnosed Kawasaki disease, adjunctive prednisolone did not reduce the incidence of coronary artery lesions compared with standard therapy alone at one month.

2. Prednisolone was associated with reduced rescue therapy use, shortened fever duration, and lowered C-reactive protein levels.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Kawasaki disease is an acute childhood vasculitis in which coronary artery involvement remains the most important complication. Despite standard treatment with intravenous immune globulin (IVIG) and aspirin, coronary artery lesions develop in up to one-fifth of affected children. Adjunctive glucocorticoids have shown benefit in populations at high risk for IVIG resistance, but their role in unselected patients has remained controversial. This phase 3, multicenter, open-label randomized controlled trial evaluated whether adding prednisolone to standard primary treatment could reduce the incidence of coronary artery lesions in children with newly diagnosed Kawasaki disease across China. It was found that adjunctive prednisolone did not reduce the development of coronary artery lesions at 1 month after illness onset. Further, among participants with coronary artery lesions, there were similar frequencies of lesion progression and of medium-to-giant aneurysms in the two groups. Prednisolone was associated with a lower likelihood of using rescue therapy, faster fever resolution, and a greater decline in C-reactive protein (CRP), although these differences were not considered clinically significant. Adverse events were similar between groups. Important limitations included the open-label design, echocardiographic assessment performed locally rather than through a central core laboratory, underpowered subgroup analyses, and the relatively short follow-up period. Taken together, these findings do not support routine addition of prednisolone to standard primary therapy for children with Kawasaki disease.

Click to read the study in NEJM

Relevant Reading: Randomized Trial of Pulsed Corticosteroid Therapy for Primary Treatment of Kawasaki Disease

In-Depth [randomized controlled trial]: In this phase 3 randomized controlled trial, 3208 children with newly diagnosed Kawasaki disease at 28 sites in China were randomly assigned in a 1:1 ratio to receive either prednisolone plus standard treatment or standard treatment alone, consisting of IVIG 2 g/kg plus aspirin. The primary endpoint was the occurrence of coronary artery lesions at 1 month. A total of 27.3% of participants had coronary artery lesions at baseline. At 1 month, coronary artery lesions were detected in 245 of 1533 participants (16.0%) in the prednisolone group and 210 of 1525 (13.8%) in the standard-treatment group, yielding an adjusted risk difference of 1.1 percentage points (p=0.31). Rescue therapy was used less often with prednisolone (4.6% vs. 10.1%; risk ratio, 0.45; 95% confidence interval [CI], 0.34 to 0.59). Median fever duration after IVIG initiation was shorter in the prednisolone group (8.4 vs. 13.2 hours; hazard ratio, 0.67; 95% CI, 0.61 to 0.73), and the reduction in CRP at 72 hours was greater (-67.5 vs. -59.8 mg/L; mean difference, -7.6 mg/L; 95% CI, -10.9 to -4.3). However, 3-month coronary outcomes remained similar, with coronary artery lesions present in 12.6% versus 10.5% of participants and progression of coronary artery lesions seen in 28.6% versus 28.9% of participants. Adverse events occurred in 2.1% of the prednisolone group and 2.8% of the standard-treatment group (p=0.17), and no deaths occurred during the trial. Overall, these results suggested that addition of prednisolone was safe but did not reduce the burden of coronary artery disease over standard therapy alone among children with Kawasaki disease.

Image: PD

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