Roberto Minutolo1, Piergiorgio Bolasco2, Paolo Chiodini3, Stefano Sposini4, Maurizio Borzumati5, Cataldo Abaterusso6, Alessandra A Mele6, Domenico Santoro7, Valeria Canale7, Alberto Santoboni8, Oliviero Filiberti9, Fulvio Fiorini10, Carlo Mura11, Patrizio Imperiali12, Silvio Borrelli13, Luigi Russo14, Luca De Nicola13, Domenico Russo14. 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@unicampania.it. 2. ASL Cagliari, Cagliari, Italy. 3. Medical Statistics Unit, University of Campania, Luigi Vanvitelli, Naples, Italy. 4. Apuane Hospital, Massa, Italy. 5. Castelli Hospital, Verbania, Italy. 6. S. Giacomo Apostolo Hospital, Castelfranco Veneto, Italy. 7. University of Messina, Messina, Italy. 8. L. Parodi Delfino Hospital, Colleferro, Italy. 9. Sant'Andrea Hospital, Vercelli, Italy. 10. Rovigo Hospital, Rovigo, Italy. 11. Santa Maria alla Gruccia Hospital, Montevarchi, Italy. 12. Arezzo Hospital, Arezzo, Italy. 13. 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. 14. University "Federico II", Naples, Italy.
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.
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 HDpatients 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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