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Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study

BACKGROUND: Despite the demonstrated efficacy and safety of biosimilar filgrastim-aafi (Nivestim™), few studies have compared its use in real-life clinical practice to the originator filgrastim (Neupogen™). OBJECTIVES: This study aimed to compare the effectiveness and safety of filgrastim and filgra...

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Autores principales: Al-Rabayah, Abeer A., Al Mashni, Ola, Hanoun, Esraa, Al Qasem, Weam, Al Momani, Deema, Al Froukh, Rawan Fawzi, Sawalha, Razan, Hammoudeh, Suzan S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9712837/
https://www.ncbi.nlm.nih.gov/pubmed/36070082
http://dx.doi.org/10.1007/s40801-022-00312-8
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author Al-Rabayah, Abeer A.
Al Mashni, Ola
Hanoun, Esraa
Al Qasem, Weam
Al Momani, Deema
Al Froukh, Rawan Fawzi
Sawalha, Razan
Hammoudeh, Suzan S.
author_facet Al-Rabayah, Abeer A.
Al Mashni, Ola
Hanoun, Esraa
Al Qasem, Weam
Al Momani, Deema
Al Froukh, Rawan Fawzi
Sawalha, Razan
Hammoudeh, Suzan S.
author_sort Al-Rabayah, Abeer A.
collection PubMed
description BACKGROUND: Despite the demonstrated efficacy and safety of biosimilar filgrastim-aafi (Nivestim™), few studies have compared its use in real-life clinical practice to the originator filgrastim (Neupogen™). OBJECTIVES: This study aimed to compare the effectiveness and safety of filgrastim and filgrastim-aafi for the primary prophylaxis of chemotherapy induced-febrile neutropenia in the real-life setting. PATIENTS AND METHODS: A retrospective cohort study included all adult cancer patients at the King Hussein Cancer Centre requiring primary prophylaxis for chemotherapy-induced febrile neutropenia between 2014 and 2016. Two cohorts were selected: patients who received filgrastim and those who received filgrastim-aafi. The primary endpoint was the incidence of febrile neutropenia; the secondary endpoints were the incidence of adverse drug reactions (ADRs), hospital admissions due to febrile neutropenia, and the mean length of hospitalization. Chi-squared tests were performed to evaluate differences between groups. Logistic regression was conducted to adjust for confounding factors. RESULTS: A total of 268 patients were identified, with 88 in the filgrastim cohort and 180 in the filgrastim-aafi cohort; 64%were females. The mean age was 47 (±15) years. The incidence of febrile neutropenia was 21.6% in the filgrastim cohort and 15% in the filgrastim-aafi cohort (P = 0.179). No statistically significant differences were detected in the incidence of hospital admission (P = 0.551) or ADRs (P = 0.623) between the two cohorts. Upon adjusting for the confounding factors, results remained statistically insignificant. CONCLUSION: Filgrastim and filgrastim-aafi had comparable effectiveness and safety as primary prophylaxis for chemotherapy-induced febrile neutropenia. More extensive prospective studies with additional insight on the cost implications are required. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-022-00312-8.
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spelling pubmed-97128372022-12-02 Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study Al-Rabayah, Abeer A. Al Mashni, Ola Hanoun, Esraa Al Qasem, Weam Al Momani, Deema Al Froukh, Rawan Fawzi Sawalha, Razan Hammoudeh, Suzan S. Drugs Real World Outcomes Original Research Article BACKGROUND: Despite the demonstrated efficacy and safety of biosimilar filgrastim-aafi (Nivestim™), few studies have compared its use in real-life clinical practice to the originator filgrastim (Neupogen™). OBJECTIVES: This study aimed to compare the effectiveness and safety of filgrastim and filgrastim-aafi for the primary prophylaxis of chemotherapy induced-febrile neutropenia in the real-life setting. PATIENTS AND METHODS: A retrospective cohort study included all adult cancer patients at the King Hussein Cancer Centre requiring primary prophylaxis for chemotherapy-induced febrile neutropenia between 2014 and 2016. Two cohorts were selected: patients who received filgrastim and those who received filgrastim-aafi. The primary endpoint was the incidence of febrile neutropenia; the secondary endpoints were the incidence of adverse drug reactions (ADRs), hospital admissions due to febrile neutropenia, and the mean length of hospitalization. Chi-squared tests were performed to evaluate differences between groups. Logistic regression was conducted to adjust for confounding factors. RESULTS: A total of 268 patients were identified, with 88 in the filgrastim cohort and 180 in the filgrastim-aafi cohort; 64%were females. The mean age was 47 (±15) years. The incidence of febrile neutropenia was 21.6% in the filgrastim cohort and 15% in the filgrastim-aafi cohort (P = 0.179). No statistically significant differences were detected in the incidence of hospital admission (P = 0.551) or ADRs (P = 0.623) between the two cohorts. Upon adjusting for the confounding factors, results remained statistically insignificant. CONCLUSION: Filgrastim and filgrastim-aafi had comparable effectiveness and safety as primary prophylaxis for chemotherapy-induced febrile neutropenia. More extensive prospective studies with additional insight on the cost implications are required. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-022-00312-8. Springer International Publishing 2022-09-07 /pmc/articles/PMC9712837/ /pubmed/36070082 http://dx.doi.org/10.1007/s40801-022-00312-8 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research Article
Al-Rabayah, Abeer A.
Al Mashni, Ola
Hanoun, Esraa
Al Qasem, Weam
Al Momani, Deema
Al Froukh, Rawan Fawzi
Sawalha, Razan
Hammoudeh, Suzan S.
Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study
title Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study
title_full Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study
title_fullStr Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study
title_full_unstemmed Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study
title_short Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study
title_sort effectiveness and safety of filgrastim (neupogen™) versus filgrastim-aafi (nivestim™) in primary prophylaxis of chemotherapy-induced febrile neutropenia: an observational cohort study
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9712837/
https://www.ncbi.nlm.nih.gov/pubmed/36070082
http://dx.doi.org/10.1007/s40801-022-00312-8
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