Efficacy and safety of a single switch from etanercept originator to etanercept biosimilar in a cohort of inflammatory arthritis

Abstract

AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe. However, there are reports about flares and adverse events (AE) as a non-medical switch remains controversial due to ethical and clinical implications (efficacy, safety, tolerability). The aim of our work was to evaluate the disease activity trend after switching from etanercept originator (oETA-Enbrel) to its biosimilar (bETA-SP4/Benepali) in a cohort of patients in Turin, Piedmont, Italy. In this area, the switch to biosimilars is stalwartly encouraged. We switched 87 patients who were in a clinical state of stability from oETA to bETA: 48 patients were affected by Rheumatoid Arthritis (RA),26 by Psoriatic Arthritis (PsA) and 13 by Ankylosing Spondylitis (AS).We evaluated VAS-pain, Global-Health, CRP, number of swollen and tender joints, Disease Activity Score on 28 joints (DAS28) for RA, Disease Activity in Psoriatic Arthritis (DAPSA) for PsA, Health Assessment Questionnaire (HAQ) and Health Assessment Questionnaire for the spondyloarthropathies (HAQ-S),Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. 11/85 patients (12.6%) stopped treatment after switching to biosimilar etanercept. No difference was found between oETA and bETA in terms of efficacy. However, some arthritis flare and AE were reported. Our data regarding maintenance of efficacy and percentage of discontinuation were in line with the existing literature.

Comparative effectiveness of etanercept originator and biosimilar for treating rheumatoid arthritis: implications for cost‐savings

“…Our analysis complements other published real-world studies, which described sustained low disease activity after switching from originator to biosimilar, and similar rates of persistence and disease activity relative to historical originator control groups. [21][22][23][24][25] In our study, one possible explanation for the low rates of prescribed switching from originator to biosimilar may reflect rheumatologists' and patients' desire to maintain existing treatment if there is a good response and stable disease, or, for patients who are not responding, a desire to try an alternative TNFi or target a different mechanism. Our study only focused on patients who commenced the ETN originator or biosimilar as the first-line agent during the study window and did not examine switching in patients who were already taking the originator prior to the biosimilar becoming available.…”

Adalimumab and ABP 501 in the Treatment of a Large Cohort of Patients with Inflammatory Arthritis: A Real Life Retrospective Analysis

“…Moreover, patients switching from originator ADA to ABP 501 showed a lower risk of treatment discontinuation. Observational data on both other ADA biosimilars such as GP2017 and SB5 [ 17 , 25 ] and other TNFi biosimilars [ 26 , 27 , 28 , 29 , 30 ] showed that switching from originator to biosimilar was tolerated generally well. The only other factor associated with a negative effect on drug survival in our cohort of patients was the year of ADA prescription.…”

Effectiveness of SB4 transition from originator etanercept in rheumatoid arthritis and axial spondyloarthritis: A subgroup analysis from the BENEFIT study

“…The percentages of patients in remission and low disease activity remained similar during the study and in almost all cases there were no disease exacerbations that justified the suspension of the drug; these outcomes are in line with those that emerged from recent real-life studies. [ 13 , 14 , 15 , 16 ]…”