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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...

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Autores principales: Ribaldone, Davide Giuseppe, Tribocco, Elisa, Rosso, Chiara, Armandi, Angelo, Vernero, Marta, Bugianesi, Elisabetta, Astegiano, Marco, Saracco, Giorgio Maria, Caviglia, Gian Paolo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
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.
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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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