Randomized Trial of Pulse Steroids in the Initial Treatment of Kawasaki Disease (KD)

We conducted a prospective randomized trial to determine whether addition of corticosteroids to IVIG might improve outcomes. Subjects met AHA criteria for KD and were treated at Childrens Hospital, Boston, between July 1998 to July, 2000 during the fi rst 10 days of fever. Subjects were randomized to receive IVIG, 2 gm/kg over 10 hours, with or without pulse IVMP, 30 mg/kg (maximum 1.5 gm) over 3 hrs. All patients received aspirin, 20 to 25 mg/kg q6h until afebrile for 48 hours, then 3-5 mg/kg/day. Twenty subjects received IVMP plus IVIG, 21 received IVIG alone. Groups were similar in baseline demographic, laboratory data, and coronary artery measurements. The mean duration of fever after starting IVIG therapy was 0.9 ± 1.2 days (mean ± SD) in the IVMP group, 2.4 ± 1.9 days in the IVIG alone group (P = 0.005, unpaired t-test). Patients treated with IVMP plus IVIG had shorter hospital stays (2.0 ± 0.8 vs. 3.3 ± 2.1 days, P = 0.007), and at six weeks, lower ESR (10.6 ± 6.0 vs.. 19.4 ± 12.4, P = 0.02) and lower mean ln CRP (-3.27 ± 0.64 vs -2.38 ±1.16, P = .01). No significant differences between treatment groups were noted in coronary dimensions at two or six weeks. IVMP was well tolerated; one child developed transient hypertension. In summary, treatment of acute KD with IVMP plus IVIG, compared to IVIG alone, resulted in faster resolution of fever, more rapid improvement in markers of inflammation, and shorter length of hospitalization. Adverse effects were infrequent. The effect of steroid therapy on coronary artery outcome, however, remains unproven. Further study of the optimal use of steroids in the treatment of KD should be performed.