Publication: Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies
2
Issued Date
2011-07-01
Resource Type
ISSN
15231755
00852538
00852538
Other identifier(s)
2-s2.0-79958824101
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Kidney International. Vol.80, No.1 (2011), 88-92
Suggested Citation
Kearkiat Praditpornsilpa, Khajohn Tiranathanagul, Pawinee Kupatawintu, Saengsuree Jootar, Tanin Intragumtornchai, Kriang Tungsanga, Tanyarat Teerapornlertratt, Dusit Lumlertkul, Natavudh Townamchai, Paweena Susantitaphong, Pisut Katavetin, Talerngsak Kanjanabuch, Yingyos Avihingsanon, Somchai Eiam-Ong Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney International. Vol.80, No.1 (2011), 88-92. doi:10.1038/ki.2011.68 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/12457
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies
Other Contributor(s)
Abstract
Recombinant human erythropoietin (r-HuEpo) has been used for the treatment of renal anemia. With the loss of its patent protection, there has been an upsurge of more affordable biosimilar agents, increasing patient access to treatment for these conditions. The complexity of the manufacturing process for these recombinant proteins, however, can result in altered properties that may significantly affect patient safety. As it is not known whether various r-HuEpo products can be safely interchanged, we studied 30 patients with chronic kidney disease treated by subcutaneous injection with biosimilar r-HuEpo and who developed a sudden loss of efficacy. Sera from 23 of these patients were positive for r-HuEpo-neutralizing antibodies, and their bone marrow biopsies indicated pure red-cell aplasia, indicating the loss of erythroblasts. Sera and bone marrow biopsies from the remaining seven patients were negative for anti-r-HuEpo antibodies and red-cell aplasia, respectively. The cause for r-HuEpo hyporesponsiveness was occult gastrointestinal bleeding. Thus, subcutaneous injection of biosimilar r-HuEpo can cause adverse immunological effects. A large, long-term, pharmacovigilance study is necessary to monitor and ensure patient safety for these agents. © 2011 International Society of Nephrology.