Objective: We conducted a prospective randomized trial to determine whether the addition of corticosteroids to intravenous immunoglobulin (IVIG) might improve outcomes in Kawasaki disease (KD).
Study design: Subjects were randomized to receive IVIG, 2 gm/kg over 10 hours, with or without pulsed-dose intravenous methylprednisolone (IVMP), 30 mg/kg. All patients received standard doses of aspirin (ASA). Groups were similar in baseline demographic and laboratory data.
Results: Patients in the IVMP plus ASA/IVIG group, compared with those in the ASA/IVIG alone group, had a shorter mean duration of fever >/=38.3 degrees C after initiation of therapy (1.0 +/- 1.3 vs 2.4 +/- 1.9 days, mean +/- SD, P =.012), shorter hospital stays (1.9 +/- 0.7 vs 3.3 +/- 2.1 days, P =.010), and at six weeks, lower mean erythrocyte sedimentation rate (11.1 +/- 5.7 vs 19.4 +/- 12.4, P =.027) and median c-reactive protein (0.03 vs 0.08, P =.011, Wilcoxon). No significant differences between treatment groups were noted in coronary dimensions, but statistical power was limited. IVMP was well tolerated; transient hypertension developed in one child, but it did not require treatment.
Conclusions: Treatment of acute KD with IVMP plus ASA/IVIG, compared with ASA/IVIG alone, resulted in faster resolution of fever, more rapid improvement in markers of inflammation, and shorter length of hospitalization. Adverse effects were infrequent. Steroid therapy should be further assessed in a multicenter, placebo-blind trial.