Cohort Prospective Study to Evaluate Immunogenicity of Epodion® (Biosimilar Epoetin-α) in Anemia Associated with Chronic Kidney Disease (CKD) Patients

Authors

  • Nova Angginy Department of Research and Development, PT Daewoong Pharmaceutical Company Indonesia, Jakarta 10340, Indonesia http://orcid.org/0000-0002-6889-9628
  • Chang Woo Suh Department of Research and Development, PT Daewoong Pharmaceutical Company Indonesia, Jakarta 10340, Indonesia
  • Jonny Jonny Poly of Internal Medicine, Gatot Soebroto Army Hospital (RSPAD), Jakarta 10410, Indonesia
  • Nuly Juariah Mahnulia Poly of Internal Medicine, Medika BSD Hospital, Tangerang 15310, Indonesia
  • Suhardjono Suhardjono Poly of Internal Medicine, PELNI Hospital, Jakarta 11410, Indonesia

Keywords:

Anemia, anti-drug antibody, anti-rhEPO, chronic kidney disease, erythropoietin

Abstract

Background: Anemia due to chronic kidney disease (CKD) is often associated with decreased erythropoietin (EPO) levels in the blood. Treatments available are improving blood iron levels and administration of exogenous EPO (rhEPO). This study aims to assess the safety and immunogenicity of Epodion, a biosimilar rhEPO product, in haemodialysis patients with CKD-associated anaemia in three Indonesian hospitals. Methods: This prospective, open label, single arm, and multicenter study enrolled patients with anemia associated with CKD under hemodialysis treatment. Patient eligibility was assessed within the 4-week screening period. Blood samples for determination of erythropoietin antibody (Anti-Drug Antibody) were taken at week-0, 24, and 52 using a validated and highly sensitive bridging ELISA method. Evaluation of Neutralizing Antibody (NAb) was carried out to confirm the impact of the antibody to pharmacological activity (e.g., antibody-mediated PRCA) when the ADA detection of patients was positive after screening and confirmatory assay. Results: Results from all tested patients show that Epodion could maintain hemoglobin and hematocrit levels. ADA detection using ELISA assay yielded negative results for all plasma samples of week-24 and week-52, so the evaluation of NAb was not carried out. No adverse events were considered relevant to tested product. Conclusion: This study proves no immunogenic effect of Epodion on stimulating immune system’s antibodies in Indonesian patients with CKD-associated anemia.

Author Biographies

Nova Angginy, Department of Research and Development, PT Daewoong Pharmaceutical Company Indonesia, Jakarta 10340, Indonesia

Clinical Research Manager

Chang Woo Suh, Department of Research and Development, PT Daewoong Pharmaceutical Company Indonesia, Jakarta 10340, Indonesia

President Director

Jonny Jonny, Poly of Internal Medicine, Gatot Soebroto Army Hospital (RSPAD), Jakarta 10410, Indonesia

Nephrology and Hypertension Specialist

Nuly Juariah Mahnulia, Poly of Internal Medicine, Medika BSD Hospital, Tangerang 15310, Indonesia

Nephrology and Hypertension Specialist

Suhardjono Suhardjono, Poly of Internal Medicine, PELNI Hospital, Jakarta 11410, Indonesia

Nephrology and Hypertension Specialist

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Published

2022-09-24

How to Cite

Angginy, N., Suh, C. W., Jonny, J., Mahnulia, N. J., & Suhardjono, S. (2022). Cohort Prospective Study to Evaluate Immunogenicity of Epodion® (Biosimilar Epoetin-α) in Anemia Associated with Chronic Kidney Disease (CKD) Patients. Acta Medica Indonesiana, 54(3), 397. Retrieved from https://www.actamedindones.org/index.php/ijim/article/view/1946

Issue

Vol. 54 No. 3 (2022): Acta Medica Indonesiana

Section

ORIGINAL ARTICLE

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