Abstract O.42: Efficacy And Safety Of Treatment With Immunoglobulin Plus Steroid For Kawasaki Disease: A Prospective Observational Study

Background: Non-responders to primary intravenous immunoglobulin (IVIG) therapy with aspirin are at risk of coronary artery lesions in Kawasaki disease (KD). A randomized controlled trial (the RAISE study) indicated that prednisolone + primary IVIG improves responsiveness to treatment and coronary artery outcomes in non-responders to IVIG predicted on the basis of Kobayashi score. The present study aimed to verify the efficacy and safety of prednisolone + primary IVIG in predicted non-responders to IVIG. Methods: We conducted a multicenter, prospective cohort study at 30 hospitals in Japan from July 2012. All KD patients received primary IVIG therapy (2 g/kg/24 h) and, if febrile at diagnosis, oral aspirin (30 mg/kg/day) and were stratified by Kobayashi score into non-responders (score [[Unable to Display Character: ]]5) and responders (score ≤4). The required sample size to reach statistical significance was 1,500 for KD patients and 500 for non-responders. Results: We enrolled 868 patients with ...