In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study

On behalf of the Italian Biosimilars Network (I-BioNetwork)

Research output: Contribution to journalArticle

Abstract

Background and objectives: Switching between different erythropoiesis-stimulating agents (ESAs) during the first year of therapy is frequent (15–20%), much more so toward reference products than biosimilars. The objectives of this study were to investigate the frequency and identify the potential predictors of switching between biosimilar and originator ESAs during the first year of treatment in patients with chronic kidney disease (CKD), or chemotherapy-related anemia from six large Italian geographic areas in the years 2009–2015. Methods: A retrospective cohort study was conducted using six Italian regional claims databases (≥ 13 million inhabitants) during 2009–2015. Among incident epoetin users, the frequency of single, multiple, and backward switch during the first year of treatment was evaluated. Using frailty Cox models, potential predictors of first switch were identified. All analyses were stratified by the main indications for use. Results: Among 102,240 incident epoetin users, 15,853 (15.5%) switched to another epoetin during the first year of therapy; only 18% of these switched to biosimilars. Single switch was more common (62.2% of the switchers) than multiple (23.5%) or backward switch (14.3%). In cancer, the cumulative number of transfusions and iron preparations dispensed, as well as hyperparathyroidism, were predictors of switching. In CKD, the cumulative number of transfusions, number of vitamin A/D preparations dispensed, and CKD severity increased the probability of switching. Conclusions: Switching between ESAs was frequent in both CKD and cancer patients. The number of cumulative transfusions and severity of disease seemed to affect the switch.

Original languageEnglish
JournalBioDrugs
DOIs
Publication statusAccepted/In press - Jan 1 2019

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Biosimilar Pharmaceuticals
Hematinics
Chronic Renal Insufficiency
Cohort Studies
Hyperparathyroidism
Kidney Neoplasms
Therapeutics
Vitamin A
Proportional Hazards Models
Vitamin D
Anemia
Iron
Retrospective Studies
Databases
Drug Therapy
Neoplasms

ASJC Scopus subject areas

  • Biotechnology
  • Pharmacology
  • Pharmacology (medical)

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In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice : A Multi-Regional Cohort Study. / On behalf of the Italian Biosimilars Network (I-BioNetwork).

In: BioDrugs, 01.01.2019.

Research output: Contribution to journalArticle

@article{6d2b0310e18a4577b08e9c68e6580ee0,
title = "In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study",
abstract = "Background and objectives: Switching between different erythropoiesis-stimulating agents (ESAs) during the first year of therapy is frequent (15–20{\%}), much more so toward reference products than biosimilars. The objectives of this study were to investigate the frequency and identify the potential predictors of switching between biosimilar and originator ESAs during the first year of treatment in patients with chronic kidney disease (CKD), or chemotherapy-related anemia from six large Italian geographic areas in the years 2009–2015. Methods: A retrospective cohort study was conducted using six Italian regional claims databases (≥ 13 million inhabitants) during 2009–2015. Among incident epoetin users, the frequency of single, multiple, and backward switch during the first year of treatment was evaluated. Using frailty Cox models, potential predictors of first switch were identified. All analyses were stratified by the main indications for use. Results: Among 102,240 incident epoetin users, 15,853 (15.5{\%}) switched to another epoetin during the first year of therapy; only 18{\%} of these switched to biosimilars. Single switch was more common (62.2{\%} of the switchers) than multiple (23.5{\%}) or backward switch (14.3{\%}). In cancer, the cumulative number of transfusions and iron preparations dispensed, as well as hyperparathyroidism, were predictors of switching. In CKD, the cumulative number of transfusions, number of vitamin A/D preparations dispensed, and CKD severity increased the probability of switching. Conclusions: Switching between ESAs was frequent in both CKD and cancer patients. The number of cumulative transfusions and severity of disease seemed to affect the switch.",
author = "{On behalf of the Italian Biosimilars Network (I-BioNetwork)} and Ylenia Ingrasciotta and Valeria Belleudi and Francesco Trotta and Antonio Addis and Andrea Fontana and Alessandro Chinellato and Valentina Ientile and Tari, {Daniele Ugo} and Giuseppe Roberto and Maurizio Pastorello and Salvatore Scondotto and Pasquale Cananzi and Giuseppe Traversa and Marina Davoli and Mariangela Rossi and Gianluca Trifir{\`o} and Caputi, {Achille P.} and Jenny Bolcato and Roberta Pirolo and Rosa Gini and Genazzani, {Armando A.} and Ilaria Uomo and Addario, {Sebastiano W.Pollina} and {Da Cas}, Roberto",
year = "2019",
month = "1",
day = "1",
doi = "10.1007/s40259-019-00385-y",
language = "English",
journal = "BioDrugs",
issn = "1172-7039",
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T1 - In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice

T2 - A Multi-Regional Cohort Study

AU - On behalf of the Italian Biosimilars Network (I-BioNetwork)

AU - Ingrasciotta, Ylenia

AU - Belleudi, Valeria

AU - Trotta, Francesco

AU - Addis, Antonio

AU - Fontana, Andrea

AU - Chinellato, Alessandro

AU - Ientile, Valentina

AU - Tari, Daniele Ugo

AU - Roberto, Giuseppe

AU - Pastorello, Maurizio

AU - Scondotto, Salvatore

AU - Cananzi, Pasquale

AU - Traversa, Giuseppe

AU - Davoli, Marina

AU - Rossi, Mariangela

AU - Trifirò, Gianluca

AU - Caputi, Achille P.

AU - Bolcato, Jenny

AU - Pirolo, Roberta

AU - Gini, Rosa

AU - Genazzani, Armando A.

AU - Uomo, Ilaria

AU - Addario, Sebastiano W.Pollina

AU - Da Cas, Roberto

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background and objectives: Switching between different erythropoiesis-stimulating agents (ESAs) during the first year of therapy is frequent (15–20%), much more so toward reference products than biosimilars. The objectives of this study were to investigate the frequency and identify the potential predictors of switching between biosimilar and originator ESAs during the first year of treatment in patients with chronic kidney disease (CKD), or chemotherapy-related anemia from six large Italian geographic areas in the years 2009–2015. Methods: A retrospective cohort study was conducted using six Italian regional claims databases (≥ 13 million inhabitants) during 2009–2015. Among incident epoetin users, the frequency of single, multiple, and backward switch during the first year of treatment was evaluated. Using frailty Cox models, potential predictors of first switch were identified. All analyses were stratified by the main indications for use. Results: Among 102,240 incident epoetin users, 15,853 (15.5%) switched to another epoetin during the first year of therapy; only 18% of these switched to biosimilars. Single switch was more common (62.2% of the switchers) than multiple (23.5%) or backward switch (14.3%). In cancer, the cumulative number of transfusions and iron preparations dispensed, as well as hyperparathyroidism, were predictors of switching. In CKD, the cumulative number of transfusions, number of vitamin A/D preparations dispensed, and CKD severity increased the probability of switching. Conclusions: Switching between ESAs was frequent in both CKD and cancer patients. The number of cumulative transfusions and severity of disease seemed to affect the switch.

AB - Background and objectives: Switching between different erythropoiesis-stimulating agents (ESAs) during the first year of therapy is frequent (15–20%), much more so toward reference products than biosimilars. The objectives of this study were to investigate the frequency and identify the potential predictors of switching between biosimilar and originator ESAs during the first year of treatment in patients with chronic kidney disease (CKD), or chemotherapy-related anemia from six large Italian geographic areas in the years 2009–2015. Methods: A retrospective cohort study was conducted using six Italian regional claims databases (≥ 13 million inhabitants) during 2009–2015. Among incident epoetin users, the frequency of single, multiple, and backward switch during the first year of treatment was evaluated. Using frailty Cox models, potential predictors of first switch were identified. All analyses were stratified by the main indications for use. Results: Among 102,240 incident epoetin users, 15,853 (15.5%) switched to another epoetin during the first year of therapy; only 18% of these switched to biosimilars. Single switch was more common (62.2% of the switchers) than multiple (23.5%) or backward switch (14.3%). In cancer, the cumulative number of transfusions and iron preparations dispensed, as well as hyperparathyroidism, were predictors of switching. In CKD, the cumulative number of transfusions, number of vitamin A/D preparations dispensed, and CKD severity increased the probability of switching. Conclusions: Switching between ESAs was frequent in both CKD and cancer patients. The number of cumulative transfusions and severity of disease seemed to affect the switch.

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