title: Multicenter, Single-Arm, Phase IV Study of Combined Aspirin and High-Dose "IVIG-SN" Therapy for Pediatric Patients with Kawasaki Disease.
abstract: OBJECTIVE
  Intravenous immunoglobulin-SN (IVIG-SN) is a new human immunoglobulin product. Its safety is ensured by pathogen-elimination steps comprising solvent/detergent treatment and a nanofiltration process. This multicenter clinical study was designed to evaluate the efficacy and safety of combined aspirin and high-dose IVIG-SN therapy in pediatric patients with Kawasaki disease (KD).
  
  
  METHODS
  We evaluated coronary artery lesions (CALs) at 2 and 7 weeks after administering IVIG-SN; total fever duration; and variations in erythrocyte sedimentation rate, N-terminal pro B-type natriuretic peptide or B-type natriuretic peptide, and creatine kinase-myocardial band level before and after treatment with IVIG-SN (2 g/kg). Adverse events were monitored.
  
  
  RESULTS
  Forty-five patients were enrolled, three of whom were excluded according to the exclusion criteria; the other 42 completed the study. The male:female ratio was 0.91:1, and the mean age was 29.11±17.23 months. The mean fever duration before IVIG-SN treatment was 6.45±1.30 days. Although most patients had complete KD (40 patients, 90.91%), four had atypical KD (9.09%). After IVIG-SN treatment, one patient (2.38%) had CALs, which was significantly lower than the incidence reported previously (15%) (p=0.022), but not significantly different from recent data (5%). There were no serious adverse events, though 28 patients (63.64%) had mild adverse events. Three adverse drug reactions occurred in 2 patients (eczema, anemia, and increased eosinophil count), all of which were transient.
  
  
  CONCLUSIONS
  IVIG-SN treatment in patients with KD was safe and effective.
authors.affiliation: Department of Pediatrics, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
authors.forename: Kyung Lim
authors.initials: KL
authors.lastname: Yoon
authors.affiliation: Department of Pediatrics, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
authors.forename: Hae Yong
authors.initials: HY
authors.lastname: Lee
authors.affiliation: Division of Pediatric Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Jeong Jin
authors.initials: JJ
authors.lastname: Yu
authors.affiliation: Division of Cardiology, Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Jae Young
authors.initials: JY
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, Kyung Hee University Hospital, Seoul, Korea.
authors.forename: Mi Young
authors.initials: MY
authors.lastname: Han
authors.affiliation: Green Cross Corporation, Seoul, Korea.
authors.forename: Ki Yong
authors.initials: KY
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Pediatrics, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: June
authors.initials: J
authors.lastname: Huh
keywords: Coronary artery disease; Immunoglobulins, intravenous; Kawasaki disease; Pediatric