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, TaeHyun Yoo, Kyu Beck Lee, Seung Ok Choi, Ea Wha Kang, Kang Wook Lee, Sung Jo Kim, Sang Kyum Kim, Tae Hwe Heo

Research output: Contribution to journalArticle

9 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)254-261
Number of pages8
JournalBiologicals
Volume40
Issue number4
DOIs
Publication statusPublished - 2012 Jul 1

Fingerprint

Pure Red-Cell Aplasia
Korea
Erythropoietin
Antibodies
Cross-Sectional Studies
Anti-Idiotypic Antibodies
Cells
Aplastic Anemia
Bioassay
Neutralizing Antibodies
Biological Assay
Assays
Serum

All Science Journal Classification (ASJC) codes

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

Cite this

Shin, S. K., Moon, S. J., Ha, S. K., Jo, Y. I., Lee, T. W., Lee, Y. S., ... Heo, T. H. (2012). Immunogenicity of recombinant human erythropoietin in Korea: A two-year cross-sectional study. Biologicals, 40(4), 254-261. https://doi.org/10.1016/j.biologicals.2012.02.003
Shin, Sug Kyun ; Moon, Sung Jin ; Ha, Sung Kyu ; Jo, Young Il ; Lee, Tae Won ; Lee, Young Sook ; Kim, Yang Wook ; Kim, Dae Joong ; Kim, Jin Kuk ; Yoo, TaeHyun ; Lee, Kyu Beck ; Choi, Seung Ok ; Kang, Ea Wha ; Lee, Kang Wook ; Kim, Sung Jo ; Kim, Sang Kyum ; Heo, Tae Hwe. / Immunogenicity of recombinant human erythropoietin in Korea : A two-year cross-sectional study. In: Biologicals. 2012 ; Vol. 40, No. 4. pp. 254-261.
@article{7cca99c6445d48db8fc697bbc7d46af1,
title = "Immunogenicity of recombinant human erythropoietin in Korea: A two-year cross-sectional study",
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.",
author = "Shin, {Sug Kyun} and Moon, {Sung Jin} and Ha, {Sung Kyu} and Jo, {Young Il} and Lee, {Tae Won} and Lee, {Young Sook} and Kim, {Yang Wook} and Kim, {Dae Joong} and Kim, {Jin Kuk} and TaeHyun Yoo and Lee, {Kyu Beck} and Choi, {Seung Ok} and Kang, {Ea Wha} and Lee, {Kang Wook} and Kim, {Sung Jo} and Kim, {Sang Kyum} and Heo, {Tae Hwe}",
year = "2012",
month = "7",
day = "1",
doi = "10.1016/j.biologicals.2012.02.003",
language = "English",
volume = "40",
pages = "254--261",
journal = "Biologicals",
issn = "1045-1056",
publisher = "Academic Press Inc.",
number = "4",

}

Shin, SK, Moon, SJ, Ha, SK, Jo, YI, Lee, TW, Lee, YS, Kim, YW, Kim, DJ, Kim, JK, Yoo, T, Lee, KB, Choi, SO, Kang, EW, Lee, KW, Kim, SJ, Kim, SK & Heo, TH 2012, 'Immunogenicity of recombinant human erythropoietin in Korea: A two-year cross-sectional study', Biologicals, vol. 40, no. 4, pp. 254-261. https://doi.org/10.1016/j.biologicals.2012.02.003

Immunogenicity of recombinant human erythropoietin in Korea : A two-year cross-sectional study. / Shin, Sug Kyun; Moon, Sung Jin; Ha, Sung Kyu; Jo, Young Il; Lee, Tae Won; Lee, Young Sook; Kim, Yang Wook; Kim, Dae Joong; Kim, Jin Kuk; Yoo, TaeHyun; Lee, Kyu Beck; Choi, Seung Ok; Kang, Ea Wha; Lee, Kang Wook; Kim, Sung Jo; Kim, Sang Kyum; Heo, Tae Hwe.

In: Biologicals, Vol. 40, No. 4, 01.07.2012, p. 254-261.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Immunogenicity of recombinant human erythropoietin in Korea

T2 - A two-year cross-sectional study

AU - Shin, Sug Kyun

AU - Moon, Sung Jin

AU - Ha, Sung Kyu

AU - Jo, Young Il

AU - Lee, Tae Won

AU - Lee, Young Sook

AU - Kim, Yang Wook

AU - Kim, Dae Joong

AU - Kim, Jin Kuk

AU - Yoo, TaeHyun

AU - Lee, Kyu Beck

AU - Choi, Seung Ok

AU - Kang, Ea Wha

AU - Lee, Kang Wook

AU - Kim, Sung Jo

AU - Kim, Sang Kyum

AU - Heo, Tae Hwe

PY - 2012/7/1

Y1 - 2012/7/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84863774587&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84863774587&partnerID=8YFLogxK

U2 - 10.1016/j.biologicals.2012.02.003

DO - 10.1016/j.biologicals.2012.02.003

M3 - Article

VL - 40

SP - 254

EP - 261

JO - Biologicals

JF - Biologicals

SN - 1045-1056

IS - 4

ER -