N Engl J Med
Steroids add no coronary benefit in initial Kawasaki treatment
Clinical Takeaway: Routine addition of prednisolone to standard first-line treatment for Kawasaki disease doesn’t reduce coronary artery complications and shouldn’t be used universally.
Kawasaki disease remains a leading cause of acquired heart disease in children, and clinicians continue to debate whether early steroids improve coronary outcomes beyond standard IVIG therapy.
In a large, multicenter randomized trial published the New England Journal of Medicine, investigators evaluated whether adding prednisolone to standard primary therapy improves outcomes in children with newly diagnosed Kawasaki disease.
The open-label study enrolled 3,208 patients across China, randomly assigning them to receive standard treatment alone or standard treatment plus prednisolone. Coronary artery lesions were common at baseline, present in 27.3% of participants.
At the primary endpoint of 1 month after illness onset, coronary artery lesions occurred in 16.0% of children treated with prednisolone plus standard therapy vs. 13.8% of those receiving standard therapy alone (adjusted risk difference, 1.1 percentage points; 95% CI, −1.0 to 3.4; P=0.31), showing no significant benefit with steroids.
Prednisolone was associated with improvements in some secondary measures. Use of rescue therapy was lower (4.6% vs. 10.1%), fever resolved faster (median 8.4 vs. 13.2 hours), and C-reactive protein declined more at 72 hours (67.5 vs. 59.8 mg/L). However, coronary artery z scores, progression of lesions at 3 months (about 29% in both groups), and rates of medium-to-giant aneurysms (1.9% vs. 1.1%) were similar. Adverse event rates didn’t differ significantly.
“The addition of prednisolone to standard primary treatment for Kawasaki disease did not reduce the incidence of coronary-artery lesions,” the authors concluded, reinforcing IVIG-based therapy as the cornerstone of initial management.
Source: Lin S, et al; Chinese Kawasaki Disease Collaboration Network. (2026, April 15). N Engl J Med. Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease