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Yoon KL, Lee HY, Yu JJ, et al. Multicenter, Single-Arm, Phase IV Study of Combined Aspirin and High-Dose "IVIG-SN" Therapy for Pediatric Patients with Kawasaki Disease. Korean Circ J. 2017;47(2):209-214doi: 10.4070/kcj.2016.0139.
Yoon, K. L., Lee, H. Y., Yu, J. J., Lee, J. Y., Han, M. Y., Kim, K. Y., & Huh, J. (2017). Multicenter, Single-Arm, Phase IV Study of Combined Aspirin and High-Dose "IVIG-SN" Therapy for Pediatric Patients with Kawasaki Disease. Korean circulation journal, 47(2), 209-214. https://doi.org/10.4070/kcj.2016.0139
Yoon, Kyung Lim, et al. "Multicenter, Single-Arm, Phase IV Study of Combined Aspirin and High-Dose "IVIG-SN" Therapy for Pediatric Patients with Kawasaki Disease." Korean circulation journal vol. 47,2 (2017): 209-214. doi: https://doi.org/10.4070/kcj.2016.0139
Yoon KL, Lee HY, Yu JJ, Lee JY, Han MY, Kim KY, Huh J. Multicenter, Single-Arm, Phase IV Study of Combined Aspirin and High-Dose "IVIG-SN" Therapy for Pediatric Patients with Kawasaki Disease. Korean Circ J. 2017 Mar;47(2):209-214. doi: 10.4070/kcj.2016.0139. Epub 2017 Mar 10. PMID: 28382076; PMCID: PMC5378027.
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Korean Circ J. 2017 Mar;47(2):209-214. doi: 10.4070/kcj.2016.0139. Epub 2017 Mar 10.

Multicenter, Single-Arm, Phase IV Study of Combined Aspirin and High-Dose "IVIG-SN" Therapy for Pediatric Patients with Kawasaki Disease.

Korean circulation journal

Kyung Lim Yoon, Hae Yong Lee, Jeong Jin Yu, Jae Young Lee, Mi Young Han, Ki Yong Kim, June Huh

Affiliations

  1. Department of Pediatrics, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
  2. Division of Pediatric Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  3. Division of Cardiology, Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  4. Department of Pediatrics, Kyung Hee University Hospital, Seoul, Korea.
  5. Green Cross Corporation, Seoul, Korea.
  6. Division of Cardiology, Department of Pediatrics, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

PMID: 28382076 PMCID: PMC5378027 DOI: 10.4070/kcj.2016.0139

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±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.

CONCLUSION: IVIG-SN treatment in patients with KD was safe and effective.

Keywords: Coronary artery disease; Immunoglobulins, intravenous; Kawasaki disease; Pediatric

Conflict of interest statement

The authors have no financial conflicts of interest.

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