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Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study
We evaluated the 3-year drug survival and efficacy of the biosimilar SB4/Benepali in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients, previously treated with etanercept (ETA). Drug survival rate was calculated using the Kaplan–Meier method and Cox propor...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8837069/ https://www.ncbi.nlm.nih.gov/pubmed/35160074 http://dx.doi.org/10.3390/jcm11030621 |
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author | Parisi, Simone Becciolini, Andrea Ditto, Maria Chiara Rozza, Davide Zanetti, Anna Laganà, Angela Peroni, Clara Lisa Centanaro Di Vittorio, Chiara Degiovanni, Rosanna Realmuto, Cristina Scirè, Carlo Alberto Priora, Marta Di Donato, Eleonora Santilli, Daniele Mozzani, Flavio Lucchini, Gianluca Ariani, Alarico Gardelli, Lucia Girelli, Francesco Arrigoni, Eugenio Platè, Ilaria Bravi, Elena Paroli, Marino Caccavale, Rosalba Salvarani, Carlo Sandri, Gilda Lumetti, Federica Volpe, Alessandro Marchetta, Antonio Fusaro, Enrico |
author_facet | Parisi, Simone Becciolini, Andrea Ditto, Maria Chiara Rozza, Davide Zanetti, Anna Laganà, Angela Peroni, Clara Lisa Centanaro Di Vittorio, Chiara Degiovanni, Rosanna Realmuto, Cristina Scirè, Carlo Alberto Priora, Marta Di Donato, Eleonora Santilli, Daniele Mozzani, Flavio Lucchini, Gianluca Ariani, Alarico Gardelli, Lucia Girelli, Francesco Arrigoni, Eugenio Platè, Ilaria Bravi, Elena Paroli, Marino Caccavale, Rosalba Salvarani, Carlo Sandri, Gilda Lumetti, Federica Volpe, Alessandro Marchetta, Antonio Fusaro, Enrico |
author_sort | Parisi, Simone |
collection | PubMed |
description | We evaluated the 3-year drug survival and efficacy of the biosimilar SB4/Benepali in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients, previously treated with etanercept (ETA). Drug survival rate was calculated using the Kaplan–Meier method and Cox proportional hazard models were developed to examine predictors of SB4 discontinuation. 236 patients (120 RA, 80 PsA and 36 AS), aged 60.7 ± 13.8 years and with an ETA duration of 4.1 ± 3.4 years were included. The 3-year retention rate for SB4 was 94.4%, 88% and 86% in AS, RA and PsA patients, respectively, with no difference between groups. Patients without comorbid disease had higher retention rates vs. patients with comorbid disease (90% vs. 60%, p < 0.0001). Disease activity, as measured by DAS28, DAPSA and BASDAI remained stable over the 3 years. Comorbid disease (hazard ratio; HR: 4.06, p < 0.0001) and HAQ at baseline (HR: 2.42, p = 0.0024) significantly increased the risk of SB4 discontinuation, while previous ETA duration was negatively associated with SB4 discontinuation (HR: 0.97, p = 0.0064). Forty-one (17.4%) patients left the study due to the interruption of the SB4 treatment, 31 (75.6%) discontinued due to inefficacy and 10 (24.4%) due to adverse events. This real-life study confirms the similar efficacy profile of ETA with long-term retention and a good safety profile in inflammatory arthritis patients. |
format | Online Article Text |
id | pubmed-8837069 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-88370692022-02-12 Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study Parisi, Simone Becciolini, Andrea Ditto, Maria Chiara Rozza, Davide Zanetti, Anna Laganà, Angela Peroni, Clara Lisa Centanaro Di Vittorio, Chiara Degiovanni, Rosanna Realmuto, Cristina Scirè, Carlo Alberto Priora, Marta Di Donato, Eleonora Santilli, Daniele Mozzani, Flavio Lucchini, Gianluca Ariani, Alarico Gardelli, Lucia Girelli, Francesco Arrigoni, Eugenio Platè, Ilaria Bravi, Elena Paroli, Marino Caccavale, Rosalba Salvarani, Carlo Sandri, Gilda Lumetti, Federica Volpe, Alessandro Marchetta, Antonio Fusaro, Enrico J Clin Med Article We evaluated the 3-year drug survival and efficacy of the biosimilar SB4/Benepali in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients, previously treated with etanercept (ETA). Drug survival rate was calculated using the Kaplan–Meier method and Cox proportional hazard models were developed to examine predictors of SB4 discontinuation. 236 patients (120 RA, 80 PsA and 36 AS), aged 60.7 ± 13.8 years and with an ETA duration of 4.1 ± 3.4 years were included. The 3-year retention rate for SB4 was 94.4%, 88% and 86% in AS, RA and PsA patients, respectively, with no difference between groups. Patients without comorbid disease had higher retention rates vs. patients with comorbid disease (90% vs. 60%, p < 0.0001). Disease activity, as measured by DAS28, DAPSA and BASDAI remained stable over the 3 years. Comorbid disease (hazard ratio; HR: 4.06, p < 0.0001) and HAQ at baseline (HR: 2.42, p = 0.0024) significantly increased the risk of SB4 discontinuation, while previous ETA duration was negatively associated with SB4 discontinuation (HR: 0.97, p = 0.0064). Forty-one (17.4%) patients left the study due to the interruption of the SB4 treatment, 31 (75.6%) discontinued due to inefficacy and 10 (24.4%) due to adverse events. This real-life study confirms the similar efficacy profile of ETA with long-term retention and a good safety profile in inflammatory arthritis patients. MDPI 2022-01-26 /pmc/articles/PMC8837069/ /pubmed/35160074 http://dx.doi.org/10.3390/jcm11030621 Text en © 2022 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 Parisi, Simone Becciolini, Andrea Ditto, Maria Chiara Rozza, Davide Zanetti, Anna Laganà, Angela Peroni, Clara Lisa Centanaro Di Vittorio, Chiara Degiovanni, Rosanna Realmuto, Cristina Scirè, Carlo Alberto Priora, Marta Di Donato, Eleonora Santilli, Daniele Mozzani, Flavio Lucchini, Gianluca Ariani, Alarico Gardelli, Lucia Girelli, Francesco Arrigoni, Eugenio Platè, Ilaria Bravi, Elena Paroli, Marino Caccavale, Rosalba Salvarani, Carlo Sandri, Gilda Lumetti, Federica Volpe, Alessandro Marchetta, Antonio Fusaro, Enrico Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study |
title | Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study |
title_full | Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study |
title_fullStr | Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study |
title_full_unstemmed | Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study |
title_short | Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study |
title_sort | efficacy and drug survival after switching from etanercept to the biosimilar sb4: a real-life long-term study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8837069/ https://www.ncbi.nlm.nih.gov/pubmed/35160074 http://dx.doi.org/10.3390/jcm11030621 |
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