Prednisolone in Kawasaki Disease Tied to Reduction in Coronary Lesions but Improved Clinical Outcomes: Study
China: In children with newly diagnosed Kawasaki Disease, adjunctive Prednisolone did not reduce coronary artery lesions at one month compared to standard therapy, but was associated with less need for rescue treatment, shorter fever duration, and lower C-reactive protein levels. These findings were reported in a randomized trial published in The New England Journal of Medicine by Siyuan Lin from the Pediatric Heart Center, Children’s Hospital of Fudan University, Shanghai, and colleagues.
Kawasaki disease is an acute inflammatory condition primarily affecting young children and is a leading cause of acquired heart disease in this population. While standard treatment—typically involving intravenous immunoglobulin (IVIG)—is effective in many cases, a subset of patients remains at risk of developing coronary artery complications. The potential role of adjunctive glucocorticoids, such as prednisolone, in improving outcomes has remained uncertain, particularly in unselected patient populations.
To investigate this, researchers conducted a large, multicenter, open-label randomized controlled trial across China. A total of 3,208 children with newly diagnosed Kawasaki disease were enrolled and assigned in equal proportions to receive either prednisolone in addition to standard therapy or standard treatment alone. The primary outcome assessed was the presence of coronary artery lesions one month after disease onset. Secondary outcomes included the requirement for rescue therapy, duration of fever, changes in inflammatory markers, and coronary artery measurements.
The researchers reported the following findings:
- Coronary artery involvement was present in over one-quarter of participants at baseline.
- At one month, the incidence of coronary artery lesions was similar in both groups.
- The addition of prednisolone did not significantly reduce coronary artery complications.
- At three months, rates of coronary abnormalities and their progression remained comparable between the two groups.
- Children receiving prednisolone required less rescue therapy than those on standard treatment alone.
- The duration of fever was shorter in the prednisolone group.
- Greater reductions in C-reactive protein levels were observed with prednisolone within 72 hours.
- Coronary artery size and changes over time were similar between both groups.
- The overall safety profile was comparable between the two treatment arms.
- Adverse event rates did not differ significantly between the groups.
The findings suggest that while adjunctive prednisolone may help in controlling acute inflammation and reducing treatment escalation, it does not confer additional protection against coronary artery complications in the short term. These results highlight the complexity of managing Kawasaki disease and underscore the need for further research to identify subgroups that may benefit from intensified therapy.
Overall, the study provides important evidence for clinicians, indicating that routine addition of prednisolone to standard treatment may not be necessary for all patients, although it may offer benefits in specific clinical aspects such as fever resolution and reduced need for rescue interventions.
Reference:
DOI: 10.1056/NEJMoa2511478
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