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, pre-viously 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 discontin-uation. 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.

Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study / Parisi, S.; Becciolini, A.; Ditto, M. C.; Rozza, D.; Zanetti, A.; Lagana, A.; Peroni, C. L.; Centanaro Di Vittorio, C.; Degiovanni, R.; Realmuto, C.; Scire, C. A.; Priora, M.; Di Donato, E.; Santilli, D.; Mozzani, F.; Lucchini, G.; Ariani, A.; Gardelli, L.; Girelli, F.; Arrigoni, E.; Plate, I.; Bravi, E.; Paroli, M.; Caccavale, R.; Salvarani, C.; Sandri, G.; Lumetti, F.; Volpe, A.; Marchetta, A.; Fusaro, E.. - In: JOURNAL OF CLINICAL MEDICINE. - ISSN 2077-0383. - 11:3(2022), pp. N/A-N/A. [10.3390/jcm11030621]

Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study

Salvarani C.
Membro del Collaboration Group
;
Sandri G.
Membro del Collaboration Group
;
Lumetti F.;
2022

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, pre-viously 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 discontin-uation. 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.
2022
11
3
N/A
N/A
Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study / Parisi, S.; Becciolini, A.; Ditto, M. C.; Rozza, D.; Zanetti, A.; Lagana, A.; Peroni, C. L.; Centanaro Di Vittorio, C.; Degiovanni, R.; Realmuto, C.; Scire, C. A.; Priora, M.; Di Donato, E.; Santilli, D.; Mozzani, F.; Lucchini, G.; Ariani, A.; Gardelli, L.; Girelli, F.; Arrigoni, E.; Plate, I.; Bravi, E.; Paroli, M.; Caccavale, R.; Salvarani, C.; Sandri, G.; Lumetti, F.; Volpe, A.; Marchetta, A.; Fusaro, E.. - In: JOURNAL OF CLINICAL MEDICINE. - ISSN 2077-0383. - 11:3(2022), pp. N/A-N/A. [10.3390/jcm11030621]
Parisi, S.; Becciolini, A.; Ditto, M. C.; Rozza, D.; Zanetti, A.; Lagana, A.; Peroni, C. L.; Centanaro Di Vittorio, C.; Degiovanni, R.; Realmuto, C.; ...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1269563
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