Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator

Abstract To date, data on effectiveness and safety of Adalimumab (ADA) biosimilars in inflammatory bowel diseases (IBDs) are lacking. Therefore, we aimed to verify the ability of ABP501 and SB5 to maintain the clinical and biochemical response induced by the ADA originator, after switching to them....

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Autores principales:	Linda Cingolani, Brigida Barberio, Fabiana Zingone, Antonio Ferronato, Lorenzo Bertani, Francesco Costa, Giorgia Bodini, Maria Giulia Demarzo, Piera Melatti, Alessandro Gubbiotti, Davide Massimi, Cesare Casadei, Renata D’Incà, Edoardo Vincenzo Savarino
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/e1df2d0bb34a4efe88e26cf19e6d58b1
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spelling	oai:doaj.org-article:e1df2d0bb34a4efe88e26cf19e6d58b12021-12-02T15:55:18ZAdalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator10.1038/s41598-021-89790-42045-2322https://doaj.org/article/e1df2d0bb34a4efe88e26cf19e6d58b12021-05-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-89790-4https://doaj.org/toc/2045-2322Abstract To date, data on effectiveness and safety of Adalimumab (ADA) biosimilars in inflammatory bowel diseases (IBDs) are lacking. Therefore, we aimed to verify the ability of ABP501 and SB5 to maintain the clinical and biochemical response induced by the ADA originator, after switching to them. We prospectively analyzed data collected from 55 patients with IBD who switched to ABP501, and 25 patients with IBD who switched to SB5, from ADA originator at four IBD Units between 2018 and 2020. In addition, we included an age and sex-matched control group (n = 38) who continued ADA originator for at least two years and who did not switch to a biosimilar drug. Clinical and biochemical data (C-Reactive Protein (CRP), fecal calprotectin (FC)), concomitant steroid and/or immunosuppressant therapy at the time of the switch and after six months were collected. At six months, in the ABP501 group, we did not observe statistically significant modifications in clinical activity of disease (p = 0.09) and FC values (p = 0.90). Some patients (n = 8) needed to add steroids at six months after switching (p = 0.01), however the need for optimization was not significant between the two timepoints (p = 0.70). Finally, 14.5% patients stopped therapy after six months. Similarly, in the SB5 group we observed a stability of clinical activity and FC values (p = 0.90 and p = 0.20), and a concomitant statistically significant decrease in CRP (p = 0.03). There were no differences in steroids/immunosuppressants need or optimizing biological therapy in this group. Finally, drug survival curves of patients who switched from originator to ABP501 and those who continued ADA originator were similar (p = 0.20). Overall, biosimilar drugs seem to be as effective and safe as the originator. Further larger and longer studies are mandatory to understand the clinical implications of these findings.Linda CingolaniBrigida BarberioFabiana ZingoneAntonio FerronatoLorenzo BertaniFrancesco CostaGiorgia BodiniMaria Giulia DemarzoPiera MelattiAlessandro GubbiottiDavide MassimiCesare CasadeiRenata D’IncàEdoardo Vincenzo SavarinoNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Linda Cingolani Brigida Barberio Fabiana Zingone Antonio Ferronato Lorenzo Bertani Francesco Costa Giorgia Bodini Maria Giulia Demarzo Piera Melatti Alessandro Gubbiotti Davide Massimi Cesare Casadei Renata D’Incà Edoardo Vincenzo Savarino Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator
description	Abstract To date, data on effectiveness and safety of Adalimumab (ADA) biosimilars in inflammatory bowel diseases (IBDs) are lacking. Therefore, we aimed to verify the ability of ABP501 and SB5 to maintain the clinical and biochemical response induced by the ADA originator, after switching to them. We prospectively analyzed data collected from 55 patients with IBD who switched to ABP501, and 25 patients with IBD who switched to SB5, from ADA originator at four IBD Units between 2018 and 2020. In addition, we included an age and sex-matched control group (n = 38) who continued ADA originator for at least two years and who did not switch to a biosimilar drug. Clinical and biochemical data (C-Reactive Protein (CRP), fecal calprotectin (FC)), concomitant steroid and/or immunosuppressant therapy at the time of the switch and after six months were collected. At six months, in the ABP501 group, we did not observe statistically significant modifications in clinical activity of disease (p = 0.09) and FC values (p = 0.90). Some patients (n = 8) needed to add steroids at six months after switching (p = 0.01), however the need for optimization was not significant between the two timepoints (p = 0.70). Finally, 14.5% patients stopped therapy after six months. Similarly, in the SB5 group we observed a stability of clinical activity and FC values (p = 0.90 and p = 0.20), and a concomitant statistically significant decrease in CRP (p = 0.03). There were no differences in steroids/immunosuppressants need or optimizing biological therapy in this group. Finally, drug survival curves of patients who switched from originator to ABP501 and those who continued ADA originator were similar (p = 0.20). Overall, biosimilar drugs seem to be as effective and safe as the originator. Further larger and longer studies are mandatory to understand the clinical implications of these findings.
format	article
author	Linda Cingolani Brigida Barberio Fabiana Zingone Antonio Ferronato Lorenzo Bertani Francesco Costa Giorgia Bodini Maria Giulia Demarzo Piera Melatti Alessandro Gubbiotti Davide Massimi Cesare Casadei Renata D’Incà Edoardo Vincenzo Savarino
author_facet	Linda Cingolani Brigida Barberio Fabiana Zingone Antonio Ferronato Lorenzo Bertani Francesco Costa Giorgia Bodini Maria Giulia Demarzo Piera Melatti Alessandro Gubbiotti Davide Massimi Cesare Casadei Renata D’Incà Edoardo Vincenzo Savarino
author_sort	Linda Cingolani
title	Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator
title_short	Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator
title_full	Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator
title_fullStr	Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator
title_full_unstemmed	Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator
title_sort	adalimumab biosimilars, abp501 and sb5, are equally effective and safe as adalimumab originator
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/e1df2d0bb34a4efe88e26cf19e6d58b1
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Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator

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