Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study

Objective Analysis of etanercept biosimilars in pediatric patients with juvenile idiopathic arthritis (JIA) in comparison with the etanercept originator in terms of efficacy and safety. Methods Patients diagnosed with JIA who started treatment with either the etanercept originator or a biosimilar af...

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Autores principales:	Franz Thiele, Ariane Klein, Anton Hospach, Daniel Windschall, Sonja Mrusek, J. Michael Ruehlmann, Gerd Horneff
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Diseases of the musculoskeletal system RC925-935
Acceso en línea:	https://doaj.org/article/1b438a336af34b0da53e55d8912c6ed0
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spelling	oai:doaj.org-article:1b438a336af34b0da53e55d8912c6ed02021-11-16T09:54:20ZEfficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study2578-574510.1002/acr2.11325https://doaj.org/article/1b438a336af34b0da53e55d8912c6ed02021-11-01T00:00:00Zhttps://doi.org/10.1002/acr2.11325https://doaj.org/toc/2578-5745Objective Analysis of etanercept biosimilars in pediatric patients with juvenile idiopathic arthritis (JIA) in comparison with the etanercept originator in terms of efficacy and safety. Methods Patients diagnosed with JIA who started treatment with either the etanercept originator or a biosimilar after January 1, 2017, were selected from the German BIKER registry (Biologics in Paediatric Rheumatology Registry). Furthermore, patients who started therapy with the originator and switched to a biosimilar during the course of therapy were identified. For both patient groups, disease activity and safety were examined and compared separately. Results After January 1, 2017, 348 patients started treatment with the etanercept originator (n = 293) or a biosimilar (n = 55). Another 57 patients switched to a biosimilar during the course of therapy. A significant decrease or a stable remission of disease activity was observed in both patient groups. The safety profiles were comparable, and frequencies and types of adverse events (AEs) and serious AEs were similar in patients starting therapy with the originator or a biosimilar. Only injection site reactions occurred slightly more frequently under biosimilar therapy, without having an impact on therapy adherence. In patients who switched therapy, the AE rate per 100 patient‐years was comparable before (26.4) and after (32.1) the switch. Conclusion In patients with JIA who require treatment with etanercept, the originator is still used much more frequently. However, our study highlights the equivalence of etanercept biosimilars for therapy for JIA. Increased use of these biosimilars in pediatric patients can therefore be recommended without hesitation.Franz ThieleAriane KleinAnton HospachDaniel WindschallSonja MrusekJ. Michael RuehlmannGerd HorneffWileyarticleDiseases of the musculoskeletal systemRC925-935ENACR Open Rheumatology, Vol 3, Iss 11, Pp 779-787 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Diseases of the musculoskeletal system RC925-935
spellingShingle	Diseases of the musculoskeletal system RC925-935 Franz Thiele Ariane Klein Anton Hospach Daniel Windschall Sonja Mrusek J. Michael Ruehlmann Gerd Horneff Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study
description	Objective Analysis of etanercept biosimilars in pediatric patients with juvenile idiopathic arthritis (JIA) in comparison with the etanercept originator in terms of efficacy and safety. Methods Patients diagnosed with JIA who started treatment with either the etanercept originator or a biosimilar after January 1, 2017, were selected from the German BIKER registry (Biologics in Paediatric Rheumatology Registry). Furthermore, patients who started therapy with the originator and switched to a biosimilar during the course of therapy were identified. For both patient groups, disease activity and safety were examined and compared separately. Results After January 1, 2017, 348 patients started treatment with the etanercept originator (n = 293) or a biosimilar (n = 55). Another 57 patients switched to a biosimilar during the course of therapy. A significant decrease or a stable remission of disease activity was observed in both patient groups. The safety profiles were comparable, and frequencies and types of adverse events (AEs) and serious AEs were similar in patients starting therapy with the originator or a biosimilar. Only injection site reactions occurred slightly more frequently under biosimilar therapy, without having an impact on therapy adherence. In patients who switched therapy, the AE rate per 100 patient‐years was comparable before (26.4) and after (32.1) the switch. Conclusion In patients with JIA who require treatment with etanercept, the originator is still used much more frequently. However, our study highlights the equivalence of etanercept biosimilars for therapy for JIA. Increased use of these biosimilars in pediatric patients can therefore be recommended without hesitation.
format	article
author	Franz Thiele Ariane Klein Anton Hospach Daniel Windschall Sonja Mrusek J. Michael Ruehlmann Gerd Horneff
author_facet	Franz Thiele Ariane Klein Anton Hospach Daniel Windschall Sonja Mrusek J. Michael Ruehlmann Gerd Horneff
author_sort	Franz Thiele
title	Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study
title_short	Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study
title_full	Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study
title_fullStr	Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study
title_full_unstemmed	Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study
title_sort	efficacy and safety of etanercept biosimilars compared with the originator for treatment of juvenile arthritis: a prospective observational study
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/1b438a336af34b0da53e55d8912c6ed0
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Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study

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