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Adjunctive Prednisolone Fails to Reduce Coronary-Artery Lesions in Kawasaki Disease
Adding prednisolone to standard treatment for Kawasaki disease did not reduce the incidence of coronary-artery lesions at one month after illness onset compared with standard treatment alone — 16.0% versus 13.8%, a small numerical difference that was not statistically meaningful (adjusted risk difference 1.1 percentage points; 95% CI −1.0 to 3.4; P = 0.31). Despite signals of improved fever resolution and reduced need for rescue therapy in the prednisolone group, the primary protective goal of preventing coronary-artery involvement was not achieved.
What Was Studied
The trial investigated whether adding the glucocorticoid prednisolone to standard primary treatment — typically intravenous immunoglobulin and aspirin — would lower the rate of coronary-artery lesions in children newly diagnosed with Kawasaki disease, assessed at one month after illness onset. The effect of adjunctive glucocorticoids in unselected patients with this condition had not previously been established through a large controlled trial.
How It Was Studied
This was a multicenter, open-label, randomized controlled trial conducted across multiple sites in China. Children with newly diagnosed Kawasaki disease were enrolled and randomly assigned in a 1:1 ratio to receive either prednisolone plus standard treatment or standard treatment alone. A total of 3,208 participants underwent randomization, making this one of the largest trials to address this question. Coronary-artery lesions were documented at baseline in 870 of the 3,184 evaluable participants (27.3%), and outcomes were assessed at both one month and three months after illness onset.
What Was Observed
- Primary outcome — no difference in coronary-artery lesions at one month: Coronary-artery lesions were detected in 16.0% of the prednisolone group and 13.8% of the standard-treatment group, a difference that was not statistically significant and whose confidence interval included zero (adjusted risk difference 1.1 percentage points; 95% CI −1.0 to 3.4; P = 0.31). The numerical trend actually favored standard treatment alone.
- Rescue therapy and fever duration showed apparent benefit with prednisolone: Fewer participants in the prednisolone group required rescue therapy (4.6% vs. 10.1%), and median fever duration was notably shorter — 8.4 hours versus 13.2 hours — suggesting a faster acute inflammatory response. CRP reduction at 72 hours was also greater in the prednisolone group (67.5 mg/L vs. 59.8 mg/L). These secondary outcomes were not corrected for multiple comparisons, however, and should be interpreted with caution.
- Three-month coronary outcomes were similar between groups: At three months, coronary-artery lesion incidence was 12.6% with prednisolone versus 10.5% with standard treatment, and coronary-artery lesion progression occurred in virtually identical proportions — 28.6% and 28.9%, respectively. The incidence of medium-to-giant coronary-artery aneurysms was numerically higher in the prednisolone group (1.9% vs. 1.1%), though interpretation of this difference requires care given the trial’s open-label design.
- Adverse event rates were comparable: The overall incidence of adverse events did not differ significantly between the two treatment groups, indicating no major safety signal for short-course prednisolone in this population.
Why This Matters
Kawasaki disease is associated with coronary-artery lesions in a substantial proportion of affected children — more than one in four participants had coronary involvement at baseline in this trial — making prevention of such lesions a critical treatment goal. This large randomized trial provides direct evidence that routine addition of prednisolone to standard primary therapy does not achieve that goal, despite its anti-inflammatory effects on fever and CRP. The findings caution against adopting adjunctive glucocorticoids as a standard first-line approach in unselected patients.
How to Read This Result
This is a high-quality, large randomized trial with a clearly neutral primary result, though the open-label design introduces the possibility of performance or assessment bias, and the secondary outcomes — which suggest some anti-inflammatory benefit — were not adjusted for multiple comparisons and should not be interpreted as confirmatory.
Limitations
The open-label design, in which both participants and clinicians were aware of treatment allocation, may have influenced clinical decisions and outcome assessment. Secondary outcomes such as fever duration and rescue therapy use were not corrected for multiplicity, raising the risk of false-positive interpretation. The trial was conducted entirely in China, which may limit the generalizability of findings to Kawasaki disease populations in other geographic and ethnic contexts.