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Biosimilar infliximab versus originator in Crohn’s disease anti-TNF-α naïve and non-naïve patients

INTRODUCTION: Data comparing response to originator and biosimilar infliximab in anti-TNF-α naïve and non-naïve Crohn’s disease patients is limited. AIM: To assess the efficacy, safety, and tolerability of a biosimilar infliximab in comparison to the originator drug in anti-TNF-α naïve and non-naïve...

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Autores principales: Kaniewska, Magdalena, Rosolowski, Mariusz, Moniuszko, Andrzej, Rydzewska, Grazyna
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Termedia Publishing House 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8456772/
https://www.ncbi.nlm.nih.gov/pubmed/34584581
http://dx.doi.org/10.5114/pg.2020.100750
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author Kaniewska, Magdalena
Rosolowski, Mariusz
Moniuszko, Andrzej
Rydzewska, Grazyna
author_facet Kaniewska, Magdalena
Rosolowski, Mariusz
Moniuszko, Andrzej
Rydzewska, Grazyna
author_sort Kaniewska, Magdalena
collection PubMed
description INTRODUCTION: Data comparing response to originator and biosimilar infliximab in anti-TNF-α naïve and non-naïve Crohn’s disease patients is limited. AIM: To assess the efficacy, safety, and tolerability of a biosimilar infliximab in comparison to the originator drug in anti-TNF-α naïve and non-naïve Crohn’s disease patients. Data comparing response in those two groups of patients are limited. MATERIAL AND METHODS: This retrospective single-centre study enrolled 168 adult Crohn’s disease patients treated for 1 year with infliximab originator or biosimilar. Assessment included achievement of clinical remission (during induction and maintenance therapy and follow-up period – 24 months) and occurrence of adverse events. RESULTS: Forty-seven patients taking infliximab and 68 on biosimilar were anti-TNF-α naïve. There were no differences in clinical remission rate between naïve and non-naïve patients after 1 year of treatment (infliximab – 80.9% and 73.1%, respectively; biosimilar – 79.4% and 74.1%, respectively). The relapse rate during the follow-up period was higher in anti-TNF-α non-naïve patients (p < 0.001) with no significant differences between two groups. Adverse events were more common in anti-TNF-α non-naïve patients with no difference between infliximab and biosimilar groups (13.3% vs. 17.6%, respectively). The infliximab group of anti-TNF-α naïve patients had a higher rate of adverse events compared to the biosimilar (8.1% vs. 1.9%), but it did not reach statistical significance. CONCLUSIONS: This is a study comparing anti-TNF-α naïve and non-naïve patients with Crohn’s disease. Relapse rate during follow-up was significantly higher in anti-TNF-α non-naïve patients, but with no significant differences between originator and biosimilar.
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spelling pubmed-84567722021-09-27 Biosimilar infliximab versus originator in Crohn’s disease anti-TNF-α naïve and non-naïve patients Kaniewska, Magdalena Rosolowski, Mariusz Moniuszko, Andrzej Rydzewska, Grazyna Prz Gastroenterol Original Paper INTRODUCTION: Data comparing response to originator and biosimilar infliximab in anti-TNF-α naïve and non-naïve Crohn’s disease patients is limited. AIM: To assess the efficacy, safety, and tolerability of a biosimilar infliximab in comparison to the originator drug in anti-TNF-α naïve and non-naïve Crohn’s disease patients. Data comparing response in those two groups of patients are limited. MATERIAL AND METHODS: This retrospective single-centre study enrolled 168 adult Crohn’s disease patients treated for 1 year with infliximab originator or biosimilar. Assessment included achievement of clinical remission (during induction and maintenance therapy and follow-up period – 24 months) and occurrence of adverse events. RESULTS: Forty-seven patients taking infliximab and 68 on biosimilar were anti-TNF-α naïve. There were no differences in clinical remission rate between naïve and non-naïve patients after 1 year of treatment (infliximab – 80.9% and 73.1%, respectively; biosimilar – 79.4% and 74.1%, respectively). The relapse rate during the follow-up period was higher in anti-TNF-α non-naïve patients (p < 0.001) with no significant differences between two groups. Adverse events were more common in anti-TNF-α non-naïve patients with no difference between infliximab and biosimilar groups (13.3% vs. 17.6%, respectively). The infliximab group of anti-TNF-α naïve patients had a higher rate of adverse events compared to the biosimilar (8.1% vs. 1.9%), but it did not reach statistical significance. CONCLUSIONS: This is a study comparing anti-TNF-α naïve and non-naïve patients with Crohn’s disease. Relapse rate during follow-up was significantly higher in anti-TNF-α non-naïve patients, but with no significant differences between originator and biosimilar. Termedia Publishing House 2020-11-12 2021 /pmc/articles/PMC8456772/ /pubmed/34584581 http://dx.doi.org/10.5114/pg.2020.100750 Text en Copyright © 2021 Termedia https://creativecommons.org/licenses/by-nc-sa/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0). License (http://creativecommons.org/licenses/by-nc-sa/4.0/ (https://creativecommons.org/licenses/by-nc-sa/4.0/) )
spellingShingle Original Paper
Kaniewska, Magdalena
Rosolowski, Mariusz
Moniuszko, Andrzej
Rydzewska, Grazyna
Biosimilar infliximab versus originator in Crohn’s disease anti-TNF-α naïve and non-naïve patients
title Biosimilar infliximab versus originator in Crohn’s disease anti-TNF-α naïve and non-naïve patients
title_full Biosimilar infliximab versus originator in Crohn’s disease anti-TNF-α naïve and non-naïve patients
title_fullStr Biosimilar infliximab versus originator in Crohn’s disease anti-TNF-α naïve and non-naïve patients
title_full_unstemmed Biosimilar infliximab versus originator in Crohn’s disease anti-TNF-α naïve and non-naïve patients
title_short Biosimilar infliximab versus originator in Crohn’s disease anti-TNF-α naïve and non-naïve patients
title_sort biosimilar infliximab versus originator in crohn’s disease anti-tnf-α naïve and non-naïve patients
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8456772/
https://www.ncbi.nlm.nih.gov/pubmed/34584581
http://dx.doi.org/10.5114/pg.2020.100750
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