Multicenter, Single-Arm, Phase IV Study of Combined Aspirin and High-Dose “IVIG-SN” Therapy for Pediatric Patients with Kawasaki Disease.
- Author:
Kyung Lim YOON
1
;
Hae Yong LEE
;
Jeong Jin YU
;
Jae Young LEE
;
Mi Young HAN
;
Ki Yong KIM
;
June HUH
Author Information
- Publication Type:Multicenter Study ; Original Article
- Keywords: Kawasaki disease; Pediatric; Immunoglobulins, intravenous; Coronary artery disease
- MeSH: Anemia; Aspirin*; Blood Sedimentation; Clinical Study; Coronary Artery Disease; Coronary Vessels; Creatine; Drug-Related Side Effects and Adverse Reactions; Eosinophils; Fever; Humans; Immunoglobulins; Immunoglobulins, Intravenous; Incidence; Mucocutaneous Lymph Node Syndrome*; Natriuretic Peptide, Brain
- From:Korean Circulation Journal 2017;47(2):209-214
- CountryRepublic of Korea
- Language:English
- 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.
