Journal of Clinical Medicine (Jan 2022)
Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study
- Simone Parisi,
- Andrea Becciolini,
- Maria Chiara Ditto,
- Davide Rozza,
- Anna Zanetti,
- Angela Laganà,
- Clara Lisa Peroni,
- Chiara Centanaro Di Vittorio,
- Rosanna Degiovanni,
- Cristina Realmuto,
- Carlo Alberto Scirè,
- Marta Priora,
- Eleonora Di Donato,
- Daniele Santilli,
- Flavio Mozzani,
- Gianluca Lucchini,
- Alarico Ariani,
- Lucia Gardelli,
- Francesco Girelli,
- Eugenio Arrigoni,
- Ilaria Platè,
- Elena Bravi,
- Marino Paroli,
- Rosalba Caccavale,
- Carlo Salvarani,
- Gilda Sandri,
- Federica Lumetti,
- Alessandro Volpe,
- Antonio Marchetta,
- Enrico Fusaro
Affiliations
- Simone Parisi
- Rheumatology Unit, Department of General and Specialistic Medicine, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, 10121 Turin, Italy
- Andrea Becciolini
- Internal Medicine and Rheumatology Unit, Department of Medicine, Azienda Ospedaliero-Universitaria di Parma, 43121 Parma, Italy
- Maria Chiara Ditto
- Rheumatology Unit, Department of General and Specialistic Medicine, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, 10121 Turin, Italy
- Davide Rozza
- Epidemiology Research Unit, Italian Society for Rheumatology, 20019 Milan, Italy
- Anna Zanetti
- Epidemiology Research Unit, Italian Society for Rheumatology, 20019 Milan, Italy
- Angela Laganà
- Rheumatology Unit, Department of General and Specialistic Medicine, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, 10121 Turin, Italy
- Clara Lisa Peroni
- Rheumatology Unit, Department of General and Specialistic Medicine, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, 10121 Turin, Italy
- Chiara Centanaro Di Vittorio
- Rheumatology Unit, Department of General and Specialistic Medicine, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, 10121 Turin, Italy
- Rosanna Degiovanni
- Rheumatology Unit, Department of General and Specialistic Medicine, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, 10121 Turin, Italy
- Cristina Realmuto
- Rheumatology Unit, Department of General and Specialistic Medicine, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, 10121 Turin, Italy
- Carlo Alberto Scirè
- Epidemiology Research Unit, Italian Society for Rheumatology, 20019 Milan, Italy
- Marta Priora
- Department of General and Specialist Medicine, Rheumatology Clinic, Hospital of Mondovì, 12100 Cuneo, Italy
- Eleonora Di Donato
- Internal Medicine and Rheumatology Unit, Department of Medicine, Azienda Ospedaliero-Universitaria di Parma, 43121 Parma, Italy
- Daniele Santilli
- Internal Medicine and Rheumatology Unit, Department of Medicine, Azienda Ospedaliero-Universitaria di Parma, 43121 Parma, Italy
- Flavio Mozzani
- Internal Medicine and Rheumatology Unit, Department of Medicine, Azienda Ospedaliero-Universitaria di Parma, 43121 Parma, Italy
- Gianluca Lucchini
- Internal Medicine and Rheumatology Unit, Department of Medicine, Azienda Ospedaliero-Universitaria di Parma, 43121 Parma, Italy
- Alarico Ariani
- Internal Medicine and Rheumatology Unit, Department of Medicine, Azienda Ospedaliero-Universitaria di Parma, 43121 Parma, Italy
- Lucia Gardelli
- Internal Medicine Unit, GB Morgagni Hospital, 47121 Forli, Italy
- Francesco Girelli
- Internal Medicine Unit, GB Morgagni Hospital, 47121 Forli, Italy
- Eugenio Arrigoni
- Department of Rheumatology, Ospedale Guglielmo da Saliceto, 29121 Piacenza, Italy
- Ilaria Platè
- Department of Rheumatology, Ospedale Guglielmo da Saliceto, 29121 Piacenza, Italy
- Elena Bravi
- Department of Rheumatology, Ospedale Guglielmo da Saliceto, 29121 Piacenza, Italy
- Marino Paroli
- Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, 04100 Latina, Italy
- Rosalba Caccavale
- Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, 04100 Latina, Italy
- Carlo Salvarani
- Rheumatology Unit, University of Modena and Reggio Emilia, 41100 Modena, Italy
- Gilda Sandri
- Rheumatology Unit, University of Modena and Reggio Emilia, 41100 Modena, Italy
- Federica Lumetti
- Rheumatology Unit, Azienda USL of Modena and AOU Policlinico of Modena, 41100 Modena, Italy
- Alessandro Volpe
- Rheumatology Unit, IRCCS Sacro Cuore Don Calabria, 37024 Negrar, Italy
- Antonio Marchetta
- Rheumatology Unit, IRCCS Sacro Cuore Don Calabria, 37024 Negrar, Italy
- Enrico Fusaro
- Rheumatology Unit, Department of General and Specialistic Medicine, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, 10121 Turin, Italy
- DOI
- https://doi.org/10.3390/jcm11030621
- Journal volume & issue
-
Vol. 11,
no. 3
p. 621
Abstract
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 p 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.
Keywords