In hemodialysis (HD), switching from erythropoiesis-stimulating agent (ESA) originators to biosimilars is associated with the need for doses approximately 10% higher, according to industry-driven studies.
The aim of this study was to evaluate the efficacy on anemia control of switching from ESA originators to biosimilars in daily clinical practice.
We retrospectively selected consecutive HD patients receiving stable intravenous ESA doses, and who had not been transfused in the previous 6 months, from 12 non-profit Italian centers. Patients switched from originators to biosimilars (n = 163) were matched with those maintained on ESA originators (n = 163) using a propensity score approach. The study duration was 24 weeks, and the primary endpoint was the mean dose difference (MDD), defined as the difference between the switch and control groups of ESA dose changes during the study (time-weighted average ESA dose minus baseline ESA dose).
Age (70 ± 13 years), male sex (63%), diabetes (29%), history of cardiovascular disease (40%), body weight (68 ± 14 kg), vascular access (86% arteriovenous fistula), hemoglobin [Hb] (11.2 ± 0.9 g/dL) and ESA dose (8504 ± 6370 IU/week) were similar in the two groups. Hb remained unchanged during the study in both groups. Conversely, ESA dose remained unchanged in the control group and progressively increased in the switch group from week 8 to 24. The time-weighted average of the ESA dose was higher in the switch group than in the control group (10,503 ± 7389 vs. 7981 ± 5858 IU/week; p = 0.001), leading to a significant MDD of 2423 IU/week (95% confidence interval [CI] 1615–3321), corresponding to a 39.6% (95% CI 24.7–54.6) higher dose of biosimilars compared with originators. The time-weighted average of Hb was 0.2 g/dL lower in the switch group, with a more frequent ESA hyporesponsiveness (14.7 vs. 2.5%). Iron parameters and other resistance factors remained unchanged.
In stable dialysis patients, switching from ESA originators to biosimilars requires 40% higher doses to maintain anemia control.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study, formal consent is not required.
Conflict of interest
Roberto Minutolo has received payment for lectures from Amgen and Roche, and a travel grant from Janssen. Luca De Nicola has received payment for lectures from Janssen and Roche. Domenico Russo has received payment for lectures from Amgen, Janssen, and Kerix. Piergiorgio Bolasco, Paolo Chiodini, Stefano Sposini, Maurizio Borzumati, Cataldo Abaterusso, Alessandra A. Mele, Domenico Santoro, Valeria Canale, Alberto Santoboni, Oliviero Filiberti, Fulvio Fiorini, Carlo Mura, Patrizio Imperiali, Silvio Borrelli, and Luigi Russo have no conflicts of interest to declare.
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Minutolo, R., Bolasco, P., Chiodini, P. et al. Effectiveness of Switch to Erythropoiesis-Stimulating Agent (ESA) Biosimilars versus Maintenance of ESA Originators in the Real-Life Setting: Matched-Control Study in Hemodialysis Patients. Clin Drug Investig 37, 965–973 (2017). https://doi.org/10.1007/s40261-017-0562-8