The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases

Abstract

Aims: Switching from originator to biosimilar is part of current practice in inflammatory rheumatic musculoskeletal diseases (iRMDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (axSpA), with evidences derived from both etanercept (ETN) to SB4-switching randomized controlled trials and real-life registries. We investigated the safety and treatment persistence of ETN/SB4 in a multi-iRMD cohort derived from two rheumatology departments in our region. Methods: Adult patients with iRMDs, treated with ETN for at least 6 months and switched to SB4 in stable clinical condition, were eligible for this retrospective evaluation. Retrospective data on adverse events, loss of efficacy and persistence on treatment were collected until latest available follow-up. Results: A total of 220 patients (85 RA, 81 PsA, 33 axSpA, 14 juvenile idiopathic arthritis and seven other conditions; 142 females, mean age 58 ± 7 years, disease duration 12 ± 4 years, ETN duration 7 ± 4 years) were enrolled, with median follow-up of 12.1 (9.7–15.8) months. A total of 50 patients (22.7%) presented with at least one adverse event, with 36 (16.4%) disease flares and 30 (13.6%: 11 for safety and 19 loss of efficacy) SB4 withdrawals. Cumulative SB4 treatment persistence was 99.1%, 88.6% and 64.6% at 6, 12 and 18 months respectively. Back-switch to ETN was performed in 17/30 cases, the remaining cases were managed with change of biologic disease modifying or conventional synthetic anti-rheumatic drug. Age was the only significant predictor of SB4 interruption at 6 months. Conclusion: Our real-life data confirm the safety profile of switching from ETN to SB4, with slightly higher treatment persistence rates compared with other real-life registries.

Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis

“…Despite this, our manuscript is representative of a real-life scenario, in which medical and non-medical switching were performed simultaneously and confirmed successful also for other compounds. 13 In conclusion, our study confirms the high value of SB5 persistence on treatment at 6 and 12 months after switching from ADA, with a safety profile in line with the current literature.…”

“…As previously presented also for other compounds, back-switching to the originator bDMARD is possible and frequently allows a return to the previous status of disease control. 13 In this light, we might not exclude a possible impact of the nocebo effect. Although the registered loss or lack of therapeutic effect were based on the physician clinical judgment and evaluation, this could have been influenced by the increase in patient-reported pain, morning stiffness, or joint tenderness.…”

“…The procedure of switching had been performed mainly for non-medical reasons, as previously reported. 13 Each patient had been informed during a clinical consultation from the treating physician regarding both medical and non-medical aspects of the practice, presenting both data from the literature and previous personal experience with biosimilar drugs. Exclusion criteria were age <18 years at the time of switching, treatment with ADA lasting for less than 6 months, and lack of follow-up visits after switching.…”

Rheumatic Diseases and Biosimilars: Evidence about Switch from Originators to Biosimilars in the Real Life

“…The interruption was due to lack of efficacy in the majority of cases (19 patients), whileit was discontinued due to safety issues in 11 patients. No interactions with other demographic or disease factors were found in this study as well [64].…”

Treatment journey in rheumatoid arthritis with biosimilars: from better access to good disease control through cost savings and prevention of nocebo effects

“…When 220 patients (85 RA, 81 psoriatic arthritis (PsA), 33 axial spondyloarthritis (AxSpA), and 21 other conditions) from a single centre in Italy were switched from reference etanercept to SB4 due to medical and non-medical reasons, retention rates were 99.1% at 6 months, 88.6% at 12 months and 64.6% at 18 months, respectively. 44 Switching from reference product to biosimilar etanercept had a similar persistence rate of 88% at 12 months in 2061 patients with inflammatory arthritis from the DANBIO registry. 36 In an ongoing non-intervention study in France (PERFUSE), 37 1374 patients were enrolled and received SB2, an infliximab biosimilar, in routine clinical practice either as their first administration of infliximab or they had transitioned from reference infliximab or another infliximab biosimilar.…”