DOSE EQUIVALENCY AND EFFICACY OF BIOSIMILAR ERYTHROPOIETIN STIMULATING AGENTS: DATA FROM REAL CLINICAL PRACTICE
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Date
2020-06
Authors
Gaipov, Abduzhappar
Issanov, Alpamys
Mursalova, Zhanar
Tulegenova, Nazia
Kakim, Zoya
Baizakov, Mukhit
Tuganbekova, Saltanat
Aljofan, Mohamad
Journal Title
Journal ISSN
Volume Title
Publisher
Pharmacology Research & Perspectives
Abstract
Recently, biosimilar erythropoietin stimulating agents become available in Kazakhstan. Important properties of the biosimilar such as dose equivalency to the original medicine (originator) and the ability to maintain hemoglobin target levels remain insufficiently described in many clinical settings. Thus, the current study aims to determine dose equivalency and hemoglobin target levels in a cohort of dialysis patients who were switched from the originator to biosimilar. Retrospective data of 74 patients from different dialysis centers who received at least 6 months of originator and switched to biosimilar and had at least 6 months follow-up were analyzed. The clinical data of 32 male and 42 female patients were collected. The mean age was 52.5 ± 13.5 years. There is no significant difference in mean levels of hemoglobin during pre-switching from originator to biosimilar (6 months prior) and post switching period (9 months after). Additionally, a subgroup analysis of 59 patients who received originator (epoetin beta), 6 months before the switch, showed similar level of hemoglobin (110.7 ± 14 vs 113.2 ± 10 g/L, P = .05) 6 months after the switch to biosimilar (epoetin zeta) at the equivalent dose regimen (69.5 ± 29 vs 68.1 ± 30 IU/kg/wk, P = .55). However, after 9 months of switching, patients using lower doses of biosimilar (69.5 ± 29 vs 63.3 ± 30 IU/kg/wk, P < .01), showed significantly higher levels of hemoglobin (110.7 ± 14 vs 114.7 ± 8 g/L, P = .01) compared to preswitching period. In conclusion, long-term use of lower doses of biosimilar managed to maintain hemoglobin within the target levels.
Description
Keywords
Type of access: Open Access, biosimilar erythropoietin stimulating agents
Citation
Gaipov, A., Issanov, A., Mursalova, Z., Tulegenova, N., Kakim, Z., Baizakov, M., Tuganbekova, S., & Aljofan, M. (2020). Dose equivalency and efficacy of biosimilar erythropoietin stimulating agents: Data from real clinical practice. Pharmacology Research & Perspectives, 8(3). https://doi.org/10.1002/prp2.594