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

Simone Parisi,Antonio Marchetta,Carlo Salvarani,Marino Paroli,Angela Laganà,Flavio Mozzani,Alessandro Volpe,Gilda Sandri,Cristina Realmuto,Clara Lisa Peroni,Rosalba Caccavale,Elena Bravi,Gianluca Lucchini,Marta Priora,Alarico Ariani,Davide Rozza,Francesco Girelli,Ilaria Platè,Rosanna Degiovanni,Chiara Centanaro Di Vittorio,Maria Chiara Ditto,Enrico Fusaro,Daniele Santilli,Eugenio Arrigoni,Lucia Gardelli,Carlo Alberto Scirè,Federica Lumetti,Andrea Becciolini,Eleonora Di Donato,Anna Zanetti

doi:10.3390/jcm11030621

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 < 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.

Highlights

Rheumatoid arthritis (RA), spondyloarthritisand psoriatic arthritis (PsA) are chronic inflammatory rheumatic diseases characterised by different clinical, laboratory and imaging hallmarks [1,2,3] that negatively impact upon patient quality of life
We examined whether some baseline characteristics, such as the duration of ETA treatment, concomitant therapy presence of comorbid disease and baseline disease activity, could influence the SB4 discontinuation
The majority of patients were female in both rheumatoid arthritis (RA) (n = 97, 80.8%) and PsA groups (n = 44, 55%) with a higher proportion of male patients affected with ankylosing spondylitis (AS) (n = 26, 72.2%)

Summary

Introduction

Psoriatic arthritis (PsA) are chronic inflammatory rheumatic diseases characterised by different clinical, laboratory and imaging hallmarks [1,2,3] that negatively impact upon patient quality of life The prevalence of these disorders varies depending on genetic and environmental factors [4] and is estimated to affect between 0.1–1% of individuals worldwide [5,6,7]. Among biological disease modifying anti-rheumatic drugs, (bDMARDs), inhibitors targeting tumour necrosis factor (TNF) alpha were the first to achieve long-term remission and to significantly improve patients’ quality of life [10] Despite their elevated cost, the three licensed TNF inhibitors (adalimumab, infliximab and etanercept) are still ranked among the most frequently used biologic drugs for the treatment of RA and PsA [11]

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