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Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn’s Disease: A Prospective Study
No data are available regarding the safety and effectiveness of the biosimilar-to-biosimilar switch of adalimumab in any disease, and in particular in Crohn’s disease (CD). The aim of our study was to provide real world data on switching from biosimilar adalimumab to another biosimilar, including mu...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8348781/ https://www.ncbi.nlm.nih.gov/pubmed/34362184 http://dx.doi.org/10.3390/jcm10153387 |
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author | Ribaldone, Davide Giuseppe Tribocco, Elisa Rosso, Chiara Armandi, Angelo Vernero, Marta Bugianesi, Elisabetta Astegiano, Marco Saracco, Giorgio Maria Caviglia, Gian Paolo |
author_facet | Ribaldone, Davide Giuseppe Tribocco, Elisa Rosso, Chiara Armandi, Angelo Vernero, Marta Bugianesi, Elisabetta Astegiano, Marco Saracco, Giorgio Maria Caviglia, Gian Paolo |
author_sort | Ribaldone, Davide Giuseppe |
collection | PubMed |
description | No data are available regarding the safety and effectiveness of the biosimilar-to-biosimilar switch of adalimumab in any disease, and in particular in Crohn’s disease (CD). The aim of our study was to provide real world data on switching from biosimilar adalimumab to another biosimilar, including multiple switching. We conducted a prospective, single-centre observational study in which we consecutively recruited all CD patients who switched from adalimumab biosimilar ABP 501 to biosimilar SB5 from January to July 2021. Sixty-one patients were included in the final analysis, of whom 43/61 (70.5%) were multiple switches (Humira(®) → ABP 501 → SB5). After 6 months of follow up, 88.5% (54/61) of patients maintained SB5 on therapy. The success of the switch (defined as no systemic corticosteroids within 6 months, non-discontinuation of SB5, no dose escalation) was achieved by 82.0% (50/61) of patients. At multivariate analysis, C-reactive protein > 5 mg/L predicted switch failure (p = 0.03). Seven patients (11.5%) experienced side effects, compared to one patient (1.6%) in the 6 pre-switch months (p = 0.03). In conclusion, switching from biosimilar to biosimilar of adalimumab did not lead to signs of safety or loss of efficacy other than those already known in the literature for the class of drugs. |
format | Online Article Text |
id | pubmed-8348781 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-83487812021-08-08 Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn’s Disease: A Prospective Study Ribaldone, Davide Giuseppe Tribocco, Elisa Rosso, Chiara Armandi, Angelo Vernero, Marta Bugianesi, Elisabetta Astegiano, Marco Saracco, Giorgio Maria Caviglia, Gian Paolo J Clin Med Article No data are available regarding the safety and effectiveness of the biosimilar-to-biosimilar switch of adalimumab in any disease, and in particular in Crohn’s disease (CD). The aim of our study was to provide real world data on switching from biosimilar adalimumab to another biosimilar, including multiple switching. We conducted a prospective, single-centre observational study in which we consecutively recruited all CD patients who switched from adalimumab biosimilar ABP 501 to biosimilar SB5 from January to July 2021. Sixty-one patients were included in the final analysis, of whom 43/61 (70.5%) were multiple switches (Humira(®) → ABP 501 → SB5). After 6 months of follow up, 88.5% (54/61) of patients maintained SB5 on therapy. The success of the switch (defined as no systemic corticosteroids within 6 months, non-discontinuation of SB5, no dose escalation) was achieved by 82.0% (50/61) of patients. At multivariate analysis, C-reactive protein > 5 mg/L predicted switch failure (p = 0.03). Seven patients (11.5%) experienced side effects, compared to one patient (1.6%) in the 6 pre-switch months (p = 0.03). In conclusion, switching from biosimilar to biosimilar of adalimumab did not lead to signs of safety or loss of efficacy other than those already known in the literature for the class of drugs. MDPI 2021-07-30 /pmc/articles/PMC8348781/ /pubmed/34362184 http://dx.doi.org/10.3390/jcm10153387 Text en © 2021 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 Ribaldone, Davide Giuseppe Tribocco, Elisa Rosso, Chiara Armandi, Angelo Vernero, Marta Bugianesi, Elisabetta Astegiano, Marco Saracco, Giorgio Maria Caviglia, Gian Paolo Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn’s Disease: A Prospective Study |
title | Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn’s Disease: A Prospective Study |
title_full | Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn’s Disease: A Prospective Study |
title_fullStr | Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn’s Disease: A Prospective Study |
title_full_unstemmed | Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn’s Disease: A Prospective Study |
title_short | Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn’s Disease: A Prospective Study |
title_sort | switching from biosimilar to biosimilar adalimumab, including multiple switching, in crohn’s disease: a prospective study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8348781/ https://www.ncbi.nlm.nih.gov/pubmed/34362184 http://dx.doi.org/10.3390/jcm10153387 |
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