Kawasaki Disease (Methylprednisolone vs Placebo Trial)

This study evaluated pulse steroid therapy in kawasaki disease (KD). Before this study started, the standard treatment for KD included a single high dose of intravenous gammaglobulin (IVIG) and aspirin. While the majority of children respond well to this treatment, some developed coronary artery aneurysms. The purpose of this trial was to see if adding steroids (methylprednisone) to the standard treatment would improve coronary artery outcomes. 199 children participated in the study.

Who was in the study?

Children with KD within the first 10 days of illness onset.

What happened during the study?

Each qualified child was randomly assigned to one of two treatment groups. One group received the standard care (gammaglobulin (IVIG) and aspirin) and the other group received the standard care plus a single dose of steroids. Patients who still had fever >36 hours after the first IVIG treatment were given a second treatment with IVIG. A medical history review was done and the following tests were done upon entry to the study, at 1 week after entry and 5 weeks after entry into the study:
  • Echocardiogram
  • Blood sample
  • Weight and height measurements
  • Recording of any events that happened during the illness

What were the results of the study?

The numbers of coronary artery aneurysms were similar between the two treatment groups. The two groups also had similar rates of mitral regurgitation, total number of days of fever and total number of days in the hospital. There was no significant difference in the number of patients who needed a second treatment with IVIG. The group that received steroids had some blood tests that indicated less inflammation at 1 week and 5 weeks after treatment, but most lab tests were the same in the two groups. Adverse events were similar in the two groups.In conclusion, adding a single dose of IV steroids to the standard treatment for KD does not improve coronary artery outcomes, adverse events or total hospital or fever days. Therefore, steroid treatment is not indicated in the initial treatment of KD. Coronary artery aneurysms were rare in both groups of patients in this study.