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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
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.
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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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