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Real-world data on the infliximab biosimilar CT-P13 (Remsima(®)) in inflammatory bowel disease
BACKGROUND: In recent years, biological therapies have revolutionized the management of inflammatory bowel disease (IBD); however, they are expensive. The development of biosimilar products has allowed us to reduce healthcare costs and improve patients’ access to these treatments. Although various s...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Baishideng Publishing Group Inc
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8717518/ https://www.ncbi.nlm.nih.gov/pubmed/35071559 http://dx.doi.org/10.12998/wjcc.v9.i36.11285 |
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author | Huguet, Jose María Cortés, Xavier Bosca-Watts, Marta Maia Aguas, Marian Maroto, Nuria Martí, Lidia Amorós, Cirilo Paredes, Jose María |
author_facet | Huguet, Jose María Cortés, Xavier Bosca-Watts, Marta Maia Aguas, Marian Maroto, Nuria Martí, Lidia Amorós, Cirilo Paredes, Jose María |
author_sort | Huguet, Jose María |
collection | PubMed |
description | BACKGROUND: In recent years, biological therapies have revolutionized the management of inflammatory bowel disease (IBD); however, they are expensive. The development of biosimilar products has allowed us to reduce healthcare costs and improve patients’ access to these treatments. Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety, there are unmet needs regarding research on these agents in the context of IBD. AIM: To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice. METHODS: An observational, prospective, multicenter study of IBD patients treated with CT-P13 in clinical practice who were naïve to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out. No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice. The primary endpoints were clinical response rates and number of adverse events. The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3, 6, 9, and 12 mo. RESULTS: A total of 220 IBD patients treated with CT-P13 (Remsima(®)) were included in the study: 87 (40%) with ulcerative colitis and 133 (60%) with Crohn’s disease. Mean age of the patients was 41.47 (SD 15.74) years, and 58% were female. Nineteen (9%) patients started treatment with CT-P13 after switching from infliximab. Of the remaining 201 patients, 142 (65%) were naïve to biologic agents. At baseline, 68.6% (n = 138/201) of patients presented with active disease. After 12 mo of treatment, 14.8% (n = 12/81) presented with active disease, and 64.2% (n = 52/81) were in clinical remission without corticosteroids. After 3 mo, 75.5% (n = 115/152) had a clinical response or achieved clinical remission, which was sustained for 12 mo (85.2%; n = 69/81). There was a decrease in specific IBD indices at 3, 6, 9, and 12 mo (P < 0.001). A total of 34 adverse events were reported by 27 (12.3%) patients, 9 (26.5%) of which were serious. CONCLUSION: CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD. |
format | Online Article Text |
id | pubmed-8717518 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Baishideng Publishing Group Inc |
record_format | MEDLINE/PubMed |
spelling | pubmed-87175182022-01-20 Real-world data on the infliximab biosimilar CT-P13 (Remsima(®)) in inflammatory bowel disease Huguet, Jose María Cortés, Xavier Bosca-Watts, Marta Maia Aguas, Marian Maroto, Nuria Martí, Lidia Amorós, Cirilo Paredes, Jose María World J Clin Cases Observational Study BACKGROUND: In recent years, biological therapies have revolutionized the management of inflammatory bowel disease (IBD); however, they are expensive. The development of biosimilar products has allowed us to reduce healthcare costs and improve patients’ access to these treatments. Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety, there are unmet needs regarding research on these agents in the context of IBD. AIM: To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice. METHODS: An observational, prospective, multicenter study of IBD patients treated with CT-P13 in clinical practice who were naïve to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out. No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice. The primary endpoints were clinical response rates and number of adverse events. The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3, 6, 9, and 12 mo. RESULTS: A total of 220 IBD patients treated with CT-P13 (Remsima(®)) were included in the study: 87 (40%) with ulcerative colitis and 133 (60%) with Crohn’s disease. Mean age of the patients was 41.47 (SD 15.74) years, and 58% were female. Nineteen (9%) patients started treatment with CT-P13 after switching from infliximab. Of the remaining 201 patients, 142 (65%) were naïve to biologic agents. At baseline, 68.6% (n = 138/201) of patients presented with active disease. After 12 mo of treatment, 14.8% (n = 12/81) presented with active disease, and 64.2% (n = 52/81) were in clinical remission without corticosteroids. After 3 mo, 75.5% (n = 115/152) had a clinical response or achieved clinical remission, which was sustained for 12 mo (85.2%; n = 69/81). There was a decrease in specific IBD indices at 3, 6, 9, and 12 mo (P < 0.001). A total of 34 adverse events were reported by 27 (12.3%) patients, 9 (26.5%) of which were serious. CONCLUSION: CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD. Baishideng Publishing Group Inc 2021-12-26 2021-12-26 /pmc/articles/PMC8717518/ /pubmed/35071559 http://dx.doi.org/10.12998/wjcc.v9.i36.11285 Text en ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved. https://creativecommons.org/licenses/by-nc/4.0/This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. |
spellingShingle | Observational Study Huguet, Jose María Cortés, Xavier Bosca-Watts, Marta Maia Aguas, Marian Maroto, Nuria Martí, Lidia Amorós, Cirilo Paredes, Jose María Real-world data on the infliximab biosimilar CT-P13 (Remsima(®)) in inflammatory bowel disease |
title | Real-world data on the infliximab biosimilar CT-P13 (Remsima(®)) in inflammatory bowel disease |
title_full | Real-world data on the infliximab biosimilar CT-P13 (Remsima(®)) in inflammatory bowel disease |
title_fullStr | Real-world data on the infliximab biosimilar CT-P13 (Remsima(®)) in inflammatory bowel disease |
title_full_unstemmed | Real-world data on the infliximab biosimilar CT-P13 (Remsima(®)) in inflammatory bowel disease |
title_short | Real-world data on the infliximab biosimilar CT-P13 (Remsima(®)) in inflammatory bowel disease |
title_sort | real-world data on the infliximab biosimilar ct-p13 (remsima(®)) in inflammatory bowel disease |
topic | Observational Study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8717518/ https://www.ncbi.nlm.nih.gov/pubmed/35071559 http://dx.doi.org/10.12998/wjcc.v9.i36.11285 |
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