Infliximab versus second intravenous immunoglobulin for treatment of resistant Kawasaki disease in the USA (KIDCARE): a randomised, multicentre comparative effectiveness trial

作者：Jane C. Burns, Samantha C. Roberts, Adriana H. Tremoulet, Feng He, Beth Feller Printz, Negar Ashouri, Supriya Jain, David E. Michalik, Kavita Sharma, Dongngan T. Truong, James B. Wood, Katherine K. Kim, Sonia Jain, Vikram C. Anand, Marsha S. Anderson, Jocelyn Y. Ang, Emily Ansusinha, Moshe Arditi, Allison H. Bartlett, Annette Baker, Archana Chatterjee, Roberta L. DeBiasi, Sarah D. de Ferranti, Cornelia L. Dekker, Chandani DeZure, Samuel R. Dominguez, Güliz Erdem, Natasha Halasa, Ashraf S. Harahsheh, Michelle Hite, Preeti Jaggi, Pei‐Ni Jone, Jessica Jones, Neeru Kaushik, Madan Kumar, Gregory Kurio, David Lloyd, John J. Manaloor, Amy McNelis, Santhosh M. Nadipuram, Jane W. Newburger, Charles Newcomer, Tiffany S. Perkins, Michael A. Portman, Jose Rafael Romero, Allison Rometo, Tova Ronis, Margalit E. Rosenkranz, Anne Heitzman Rowley, Nichole Samuy, Paul Scalici, Jennifer E. Schuster, S. Kristen Sexson Tejtel, Kari A. Simonsen, Jacqueline Szmuszkovicz, Sylvia H. Yeh · 发表于：The Lancet Child & Adolescent Health · 年份：2021 · DOI：10.1016/s2352-4642(21)00270-4 · 被引用次数：117 · 研究领域：Kawasaki Disease and Coronary Complications、Neonatal and Maternal Infections、Lymphadenopathy Diagnosis and Analysis

BACKGROUND: Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease, 10-20% of patients have recrudescent fever as a sign of persistent inflammation and require additional treatment. We aimed to compare infliximab with a second infusion of IVIG for treatment of resistant Kawasaki disease. METHODS: In this multicentre comparative effectiveness trial, patients (aged 4 weeks to 17 years) with IVIG resistant Kawasaki disease and fever at least 36 h after completion of their first IVIG infusion were recruited from 30 hospitals across the USA. Patients were randomly assigned (1:1) to second IVIG (2 g/kg over 8-12 h) or intravenous infliximab (10 mg/kg over 2 h without premedication), by using a randomly permuted block randomisation design with block size of two or four. Patients with fever 24 h to 7 days following completion of first study treatment crossed over to receive the other study treatment. The primary outcome measure was resolution of fever at 24 h after initiation of study treatment with no recurrence of fever attributed to Kawasaki disease within 7 days post-discharge. Secondary outcome measures included duration of fever from enrolment, duration of hospitalisation after randomisation, and changes in markers of inflammation and coronary artery Z score. Efficacy was analysed in participants who received treatment and had available outcome values. Safety was analysed in all randomised patients who did not withdraw consent. This clinical trial ...