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

 Sug-Kyun Shin  ;  Sung Jin Moon  ;  Sung Kyu Ha  ;  Young-Il Jo  ;  Tae-Won Lee  ;  Young Sook Lee  ;  Yang-Wook Kim  ;  Dae Joong Kim  ;  Jin Kuk Kim  ;  Tae-Hyun Yoo  ;  Kyu-Beck Lee  ;  Seung Ok Choi  ;  Ea Wha Kang  ;  Kang Wook Lee  ;  Sung-Jo Kim  ;  Sang Kyum Kim  ;  Tae-Hwe Heo 
 BIOLOGICALS, Vol.40(4) : 254-261, 2012 
Journal Title
Issue Date
Adult ; Cross-Sectional Studies ; Enzyme-Linked Immunosorbent Assay ; Erythropoietin/immunology* ; Female ; Humans ; Korea ; Male ; Middle Aged ; Recombinant Proteins/immunology
Antibody ; End-stage renal disease ; Erythropoietin ; Immunogenicity ; Pure red cell aplasia
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Yoo, Tae Hyun(유태현) ORCID logo https://orcid.org/0000-0002-9183-4507
Ha, Sung Kyu(하성규)
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