Prednisolone plus standard treatment did not significantly reduce coronary-artery lesions in newly diagnosed Kawasaki disease patients.

This multicenter, open-label, randomized, controlled trial investigated the efficacy of adding prednisolone to standard treatment for Kawasaki disease. The study population consisted of 3208 participants with newly diagnosed Kawasaki disease recruited from settings in China. The primary objective was to determine whether the addition of prednisolone would reduce the occurrence of coronary-artery lesions at 1 month after illness onset compared to standard treatment alone. The follow-up period for the primary outcome was 1 month.

The intervention group received prednisolone plus standard treatment, while the comparator group received standard treatment alone. The specific dosing protocol for prednisolone was not detailed in the provided data, but the administration was part of the standard care protocol modified by the addition of the corticosteroid. The primary outcome, occurrence of coronary-artery lesions at 1 month, was observed in 16.0% of the prednisolone group versus 13.8% in the standard treatment group. The adjusted risk difference was 1.1 percentage points, with a 95% confidence interval ranging from -1.0 to 3.4 and a P value of 0.31. This indicates no significant reduction in coronary-artery lesions with the addition of prednisolone.

Secondary outcomes provided mixed results regarding clinical markers. The incidence of medium-to-giant coronary-artery aneurysms was 1.9% in the prednisolone group versus 1.1% in the standard treatment group. Progression of coronary-artery lesions occurred in 28.6% of the prednisolone group versus 28.9% in the standard treatment group. At 3 months, coronary-artery lesions were present in 12.6% of the prednisolone group versus 10.5% in the standard treatment group. Regarding rescue therapy, receipt was 4.6% in the prednisolone group versus 10.1% in the standard treatment group. Changes in coronary-artery z scores were similar in the two groups.

In terms of inflammatory and symptomatic markers, the median duration of fever was 8.4 hours in the prednisolone group versus 13.2 hours in the standard treatment group. The reduction in C-reactive protein level at 72 hours was 67.5 mg per liter in the prednisolone group versus 59.8 mg per liter in the standard treatment group. However, these improvements in fever duration and CRP reduction did not translate into a statistically significant reduction in the primary cardiovascular outcome of coronary-artery lesions.

Safety and tolerability findings indicated that the overall incidence of adverse events did not differ significantly between the two groups. Serious adverse events were not reported. Discontinuations and specific tolerability metrics were not reported in the provided data. The study was funded by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences and the National Natural Science Foundation of China. A key methodological limitation noted was that analyses were not controlled for multiplicity.

The results suggest that while prednisolone may offer symptomatic relief by reducing fever duration and inflammatory markers, it does not appear to confer a significant protective benefit against coronary-artery lesions when added to standard treatment in this large cohort. Clinicians should interpret these findings with caution, particularly given the lack of multiplicity control in the analyses. Further research is needed to clarify the role of corticosteroids in Kawasaki disease management, as the current evidence does not support a significant reduction in coronary-artery complications with this intervention.

Key takeaway: Consider that prednisolone did not significantly reduce coronary-artery lesions in Kawasaki disease patients.