Adjunctive Prednisolone Does Not Lower Coronary Lesions in Kawasaki Disease

Key Takeaways

• Adjunctive prednisolone was not associated with a lower 1-month incidence of coronary-artery lesions.
• Prednisolone was associated with lower rescue-therapy use, shorter fever duration, and greater CRP reduction, while coronary z-score decreases were similar between groups.
• Three-month coronary findings were broadly similar, and overall adverse-event incidence did not differ significantly between groups.

Adjunctive prednisolone did not lower the prespecified 1-month coronary outcome in 3,208 participants with newly diagnosed Kawasaki disease enrolled in a randomized Kawasaki disease trial in China. Participants received prednisolone plus standard treatment or standard treatment alone, and the main coronary endpoint was not reduced at 1 month after illness onset. The result was directionally unfavorable for the adjunctive regimen despite the trial's large enrollment.

This multicenter, open-label, randomized controlled trial in China assigned participants in a 1:1 ratio to prednisolone plus standard treatment or standard treatment alone, and 3,208 underwent randomization across participating centers. The primary outcome was coronary-artery lesions at 1 month after illness onset, and baseline lesions were present in 870 of 3,184 participants, or 27.3%. The trial evaluated whether adjunctive prednisolone during initial treatment would alter early coronary outcomes.

At 1 month, coronary-artery lesions were detected in 16.0% of the prednisolone group and 13.8% of the standard-treatment group, for an adjusted risk difference of 1.1 percentage points (95% confidence interval, −1.0 to 3.4; P=0.31). Rescue therapy was used in 4.6% versus 10.1%, median fever duration was 8.4 versus 13.2 hours, and CRP reduction at 72 hours was 67.5 versus 59.8 mg/L. Decreases in coronary-artery z scores were similar in both groups, and these prespecified secondary analyses were not adjusted for multiplicity.

At 3 months, coronary-artery lesions were present in 12.6% with prednisolone plus standard treatment and 10.5% with standard treatment alone. Progression of coronary-artery lesions occurred in 28.6% versus 28.9%, and medium-to-giant coronary-artery aneurysms occurred in 1.9% versus 1.1%. The overall incidence of adverse events did not differ significantly between the two groups. Adding prednisolone to standard primary treatment did not reduce coronary-artery lesions at 1 month after illness onset.