Korean Circulation Journal

The Korean Society of Cardiology (대한심장학회)
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Multicenter, Single-Arm, Phase IV Study of Combined Aspirin and High-Dose "IVIG-SN" Therapy for Pediatric Patients with Kawasaki Disease

  • Yoon, Kyung Lim (Department of Pediatrics, Kyung Hee University Hospital at Gangdong) ;
  • Lee, Hae Yong (Department of Pediatrics, Wonju Severance Christian Hospital, Yonsei University) ;
  • Yu, Jeong Jin (Division of Pediatric Cardiology, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Lee, Jae Young (Division of Cardiology, Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Han, Mi Young (Department of Pediatrics, Kyung Hee University Hospital) ;
  • Kim, Ki Yong (Green Cross Corporation) ;
  • Huh, June (Division of Cardiology, Department of Pediatrics, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine)
  • Received : 2016.03.28
  • Accepted : 2016.11.22
  • Published : 2017.03.31
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Abstract

Background and Objectives: 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). Subjects and 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 $29.11{\pm}17.23months$. The mean fever duration before IVIG-SN treatment was $6.45{\pm}1.30days$. 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. Conclusion: IVIG-SN treatment in patients with KD was safe and effective.

Keywords

References

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