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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

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Abstract

Background

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.

Objective

The aim of this study was to evaluate the efficacy on anemia control of switching from ESA originators to biosimilars in daily clinical practice.

Methods

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).

Results

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.

Conclusions

In stable dialysis patients, switching from ESA originators to biosimilars requires 40% higher doses to maintain anemia control.

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Authors and Affiliations

  1. Division of Nephrology, Department of Scienze Mediche, Chirurgiche, Neurologiche, Metaboliche e dell’Invecchiamento, University of Campania “Luigi Vanvitelli”, Via M. Longo 50, 80138, Naples, Italy

    Roberto Minutolo, Silvio Borrelli & Luca De Nicola

  2. ASL Cagliari, Cagliari, Italy

    Piergiorgio Bolasco

  3. Medical Statistics Unit, University of Campania, Luigi Vanvitelli, Naples, Italy

    Paolo Chiodini

  4. Apuane Hospital, Massa, Italy

    Stefano Sposini

  5. Castelli Hospital, Verbania, Italy

    Maurizio Borzumati

  6. S. Giacomo Apostolo Hospital, Castelfranco Veneto, Italy

    Cataldo Abaterusso & Alessandra A. Mele

  7. University of Messina, Messina, Italy

    Domenico Santoro & Valeria Canale

  8. L. Parodi Delfino Hospital, Colleferro, Italy

    Alberto Santoboni

  9. Sant’Andrea Hospital, Vercelli, Italy

    Oliviero Filiberti

  10. Rovigo Hospital, Rovigo, Italy

    Fulvio Fiorini

  11. Santa Maria alla Gruccia Hospital, Montevarchi, Italy

    Carlo Mura

  12. Arezzo Hospital, Arezzo, Italy

    Patrizio Imperiali

  13. University “Federico II”, Naples, Italy

    Luigi Russo & Domenico Russo

Authors
  1. Roberto Minutolo
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  2. Piergiorgio Bolasco
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  17. Luca De Nicola
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  18. Domenico Russo
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Corresponding author

Correspondence to Roberto Minutolo.

Ethics declarations

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.

Funding

None.

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

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  • DOI: https://doi.org/10.1007/s40261-017-0562-8

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