Corticosteroids in the initial treatment of Kawasaki disease: Report of a randomized trial☆☆☆★

Abstract 

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°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. (J Pediatr 2003;142:611-6)

Abbreviations:  ASA , Aspirin, CRP , C-reactive protein, ESR , Erythrocyte sedimentation rate, IVIG , Intravenous immunoglobulin, IVMP , Intravenous methylprednisolone, KD , Kawasaki disease, TNF , Tumor necrosis factor