Safety of switching between rituximab biosimilars in onco-hematology

Abstract Comparable clinical efficacy and safety of the reference rituximab (MABTHERA) and its biosimilars has been established in randomized trials. However, safety concerns are often raised when switching from reference to biosimilar products and between different biosimilars. In this prospective...

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Autores principales:	Silvana A. M. Urru, Stefania Spila Alegiani, Anna Guella, Giuseppe Traversa, Annalisa Campomori
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/68f49def5d11436693923505682f41e0
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spelling	oai:doaj.org-article:68f49def5d11436693923505682f41e02021-12-02T16:30:47ZSafety of switching between rituximab biosimilars in onco-hematology10.1038/s41598-021-85563-12045-2322https://doaj.org/article/68f49def5d11436693923505682f41e02021-03-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-85563-1https://doaj.org/toc/2045-2322Abstract Comparable clinical efficacy and safety of the reference rituximab (MABTHERA) and its biosimilars has been established in randomized trials. However, safety concerns are often raised when switching from reference to biosimilar products and between different biosimilars. In this prospective observational study we aimed at evaluating the safety of switching between reference and biosimilar rituximab (TRUXIMA and RIXATHON) at Trento General Hospital (Italy). All patients (n = 83) with Non Hodgkin’s Lymphoma (NHL, n = 72) and Chronic Lymphocytic Leukemia (CLL, n = 11) who received rituximab between March 2018 and March 2019 were asked to take part in the study. In 2017 and 2018 two tenders were carried out and two different biosimilars became available in the hospital, these were used sequentially. Thus, patients with or without previous treatments with the originator rituximab either received a biosimilar or were switched between different biosimilars. The incidence of adverse events in these groups of patients is described. The study population received 465 rituximab infusions and all received biosimilars. Fifty patients (60%) experienced at least one switch between different biosimilars or between rituximab originator and biosimilar, whereas 33 (40%) received one of the two biosimilars and one patient received reference rituximab. Adverse events (n = 146) were reported in 71 patients (84.5%). Treatment-related grade 3–4 events were reported in 5 patients (5.9%), whereas grade 1 rituximab related infusion events were observed in 6 patients (7.1%). No safety signal emerged in association with the use of a specific biosimilar nor with the practice of switching. Adverse events were similar, in terms of seriousness and frequency, to those described in the literature, providing further support to the clinical safety of rituximab biosimilars.Silvana A. M. UrruStefania Spila AlegianiAnna GuellaGiuseppe TraversaAnnalisa CampomoriNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-5 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Silvana A. M. Urru Stefania Spila Alegiani Anna Guella Giuseppe Traversa Annalisa Campomori Safety of switching between rituximab biosimilars in onco-hematology
description	Abstract Comparable clinical efficacy and safety of the reference rituximab (MABTHERA) and its biosimilars has been established in randomized trials. However, safety concerns are often raised when switching from reference to biosimilar products and between different biosimilars. In this prospective observational study we aimed at evaluating the safety of switching between reference and biosimilar rituximab (TRUXIMA and RIXATHON) at Trento General Hospital (Italy). All patients (n = 83) with Non Hodgkin’s Lymphoma (NHL, n = 72) and Chronic Lymphocytic Leukemia (CLL, n = 11) who received rituximab between March 2018 and March 2019 were asked to take part in the study. In 2017 and 2018 two tenders were carried out and two different biosimilars became available in the hospital, these were used sequentially. Thus, patients with or without previous treatments with the originator rituximab either received a biosimilar or were switched between different biosimilars. The incidence of adverse events in these groups of patients is described. The study population received 465 rituximab infusions and all received biosimilars. Fifty patients (60%) experienced at least one switch between different biosimilars or between rituximab originator and biosimilar, whereas 33 (40%) received one of the two biosimilars and one patient received reference rituximab. Adverse events (n = 146) were reported in 71 patients (84.5%). Treatment-related grade 3–4 events were reported in 5 patients (5.9%), whereas grade 1 rituximab related infusion events were observed in 6 patients (7.1%). No safety signal emerged in association with the use of a specific biosimilar nor with the practice of switching. Adverse events were similar, in terms of seriousness and frequency, to those described in the literature, providing further support to the clinical safety of rituximab biosimilars.
format	article
author	Silvana A. M. Urru Stefania Spila Alegiani Anna Guella Giuseppe Traversa Annalisa Campomori
author_facet	Silvana A. M. Urru Stefania Spila Alegiani Anna Guella Giuseppe Traversa Annalisa Campomori
author_sort	Silvana A. M. Urru
title	Safety of switching between rituximab biosimilars in onco-hematology
title_short	Safety of switching between rituximab biosimilars in onco-hematology
title_full	Safety of switching between rituximab biosimilars in onco-hematology
title_fullStr	Safety of switching between rituximab biosimilars in onco-hematology
title_full_unstemmed	Safety of switching between rituximab biosimilars in onco-hematology
title_sort	safety of switching between rituximab biosimilars in onco-hematology
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/68f49def5d11436693923505682f41e0
work_keys_str_mv	AT silvanaamurru safetyofswitchingbetweenrituximabbiosimilarsinoncohematology AT stefaniaspilaalegiani safetyofswitchingbetweenrituximabbiosimilarsinoncohematology AT annaguella safetyofswitchingbetweenrituximabbiosimilarsinoncohematology AT giuseppetraversa safetyofswitchingbetweenrituximabbiosimilarsinoncohematology AT annalisacampomori safetyofswitchingbetweenrituximabbiosimilarsinoncohematology
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Safety of switching between rituximab biosimilars in onco-hematology

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