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Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease

(1) Background: GP2017 is one of the biosimilar drugs of adalimumab, one of the anti-TNF agents used for inflammatory bowel disease (IBD). To date, there is little real-world data about the use of GP2017 in IBD patients. The aim of our study was to evaluate the effectiveness and safety of this biosi...

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Autores principales: Vernero, Marta, Bezzio, Cristina, Ribaldone, Davide G., Costa, Stefania, Scalvini, Davide, Tribocco, Elisa, Manes, Gianpiero, Saibeni, Simone
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10647534/
https://www.ncbi.nlm.nih.gov/pubmed/37959304
http://dx.doi.org/10.3390/jcm12216839
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author Vernero, Marta
Bezzio, Cristina
Ribaldone, Davide G.
Costa, Stefania
Scalvini, Davide
Tribocco, Elisa
Manes, Gianpiero
Saibeni, Simone
author_facet Vernero, Marta
Bezzio, Cristina
Ribaldone, Davide G.
Costa, Stefania
Scalvini, Davide
Tribocco, Elisa
Manes, Gianpiero
Saibeni, Simone
author_sort Vernero, Marta
collection PubMed
description (1) Background: GP2017 is one of the biosimilar drugs of adalimumab, one of the anti-TNF agents used for inflammatory bowel disease (IBD). To date, there is little real-world data about the use of GP2017 in IBD patients. The aim of our study was to evaluate the effectiveness and safety of this biosimilar in an IBD population. (2) Methods: This is an observational retrospective study including patients that were all treated with GP2017 as a first step or as a switch from the originator or other biosimilars. The clinical activity was evaluated at baseline and after 6 and 12 months of therapy. The therapy discontinuation and side effects were also evaluated. (3) Results: a total of 72 patients were included (65 with Crohn’s disease and 7 with ulcerative colitis). Of the 29 patients starting GP2017 as a first adalimumab therapy, clinical remission was achieved in 58.6%. Of the patients starting GP2017 as a switch from the originator (33 patients) or other biosimilars (10 patients), clinical remission was maintained in 78.8% and in 70%, respectively. Regarding the safety, only 11 patients experienced non-serious side effects. During the follow-up, nine patients suspended treatment mainly due to side effects or secondary failure. (4) Conclusions: GP2017 is an effective and safe therapy for IBD patients.
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spelling pubmed-106475342023-10-29 Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease Vernero, Marta Bezzio, Cristina Ribaldone, Davide G. Costa, Stefania Scalvini, Davide Tribocco, Elisa Manes, Gianpiero Saibeni, Simone J Clin Med Article (1) Background: GP2017 is one of the biosimilar drugs of adalimumab, one of the anti-TNF agents used for inflammatory bowel disease (IBD). To date, there is little real-world data about the use of GP2017 in IBD patients. The aim of our study was to evaluate the effectiveness and safety of this biosimilar in an IBD population. (2) Methods: This is an observational retrospective study including patients that were all treated with GP2017 as a first step or as a switch from the originator or other biosimilars. The clinical activity was evaluated at baseline and after 6 and 12 months of therapy. The therapy discontinuation and side effects were also evaluated. (3) Results: a total of 72 patients were included (65 with Crohn’s disease and 7 with ulcerative colitis). Of the 29 patients starting GP2017 as a first adalimumab therapy, clinical remission was achieved in 58.6%. Of the patients starting GP2017 as a switch from the originator (33 patients) or other biosimilars (10 patients), clinical remission was maintained in 78.8% and in 70%, respectively. Regarding the safety, only 11 patients experienced non-serious side effects. During the follow-up, nine patients suspended treatment mainly due to side effects or secondary failure. (4) Conclusions: GP2017 is an effective and safe therapy for IBD patients. MDPI 2023-10-29 /pmc/articles/PMC10647534/ /pubmed/37959304 http://dx.doi.org/10.3390/jcm12216839 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Vernero, Marta
Bezzio, Cristina
Ribaldone, Davide G.
Costa, Stefania
Scalvini, Davide
Tribocco, Elisa
Manes, Gianpiero
Saibeni, Simone
Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease
title Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease
title_full Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease
title_fullStr Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease
title_full_unstemmed Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease
title_short Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease
title_sort efficacy and safety of adalimumab biosimilar gp2017 in patients with inflammatory bowel disease
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10647534/
https://www.ncbi.nlm.nih.gov/pubmed/37959304
http://dx.doi.org/10.3390/jcm12216839
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