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Immunogenicity of recombinant human erythropoietin in Korea: A two-year cross-sectional study

Title
 Immunogenicity of recombinant human erythropoietin in Korea: A two-year cross-sectional study
Authors
 Sug-Kyun Shin; Sung Jin Moon; Tae-Hwe Heo; Sang Kyum Kim; Sung-Jo Kim; Kang Wook Lee; Ea Wha Kang; Seung Ok Choi; Kyu-Beck Lee; Tae-Hyun Yoo; Jin Kuk Kim; Dae Joong Kim; Yang-Wook Kim; Young Sook Lee; Tae-Won Lee; Young-Il Jo; Sung Kyu Ha
Issue Date
2012
Journal Title
 Biologicals
ISSN
 1045-1056
Citation
 Biologicals, Vol.40(4) : 254~261, 2012
Abstract
Immunogenicity of erythropoietin (EPO) is related with pure red cell aplasia (PRCA). We sought to determine the prevalence of antibody (Ab)-mediated PRCA in Korea and threshold diagnostic criteria by dual parameters: Ab titer and neutralizing activity. This study was a multi-center, cross-sectional study for two years. In the first year study (1 YS), 209 samples suspected to be EPO resistance were collected. In the second year study (2 YS), all the patients who consented to participate (N = 946) were enrolled. In 1 YS, we found three and six serum samples that were positive and borderline for anti-EPO Abs, respectively. The first three patients had neutralizing activity (NT) and were diagnosed as PRCA. In 2 YS, seven patients were anti-EPO positives and six had borderline levels. Among them, one patient with NT was diagnosed as PRCA and one with NT as aplastic anemia. The prevalence of PRCA was 0.106%. The correlation analysis of the 22 patients who had anti-EPO Ab showed that dual crossed cut-off lines (anti-EPO Ab titer ≥ 40 ng/ml, % NT ≥ 25%) were able to clearly isolate red cell aplasia. We suggest novel diagnostic criteria for diagnosis and prediction of Ab-mediated PRCA with data from both Ab titer assays and NT bioassays.
URI
http://ir.ymlib.yonsei.ac.kr/handle/22282913/89720
DOI
10.1016/j.biologicals.2012.02.003
Appears in Collections:
1. 연구논문 > 1. College of Medicine > Dept. of Internal Medicine
Yonsei Authors
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Link
 http://www.sciencedirect.com/science/article/pii/S1045105612000279
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