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

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16 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)254-261
Number of pages8
Issue number4
Publication statusPublished - 2012 Jul

Bibliographical note

Funding Information:
This research was supported by a grant ( 08122KFDA292 ) from the Korean Food and Drug Administration in 2008. This study was supported by the Research Fund 2011 of The Catholic University of Korea . This research was supported by the Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology ( 2010-0002816 ).

All Science Journal Classification (ASJC) codes

  • Biotechnology
  • Bioengineering
  • Applied Microbiology and Biotechnology
  • Immunology and Microbiology(all)
  • Pharmacology


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