Efficacy and safety of original and biosimilar etanercept (SB4) in active rheumatoid arthritis – A comparison in a real-world national cohort

Codreanu, Cătălin; Popescu, C; Mogoşan, Corina; Enache, Luminița; Daia, S.; Ionescu, Ruxandra; Opriş-Belinski, Daniela

doi:10.1016/j.biologicals.2019.10.009

Cited by 23 publications

(15 citation statements)

References 24 publications

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“…Moreover, our results are in line with the other studies conducted in adult patients with inflammatory arthritis treated with BIOs of ADA and ETA [40][41][42][43][44][45][46][47][48]50]. The demonstration of similar efficacy of BIOs comes from different study settings, primarily RCTs for both drugs, while observational studies are available mainly for etanercept because for adalimumab they are still lacking.…”

Section: Discussionsupporting

confidence: 89%

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OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis

et al. 2021

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Objectives Limited data about use of biosimilars are available in children with Juvenile Idiopathic Arthritis (JIA). This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars, in children with JIA, in a real-world setting. Methods This is a retro-prospective non-interventional multicentre Italian comparative cohort study. Medical charts of JIA children treated with biosimilars of ETA or ADA were included. Efficacy and safety of TNF-inhibitors therapy was evaluated at last follow-up during originator and at 3, 6 and 12 months following the switch to biosimilar. Results 59 children (42 female, median age at onset 88 months) were treated with biosimilar of ETA (21) and ADA (38). Forty-five switched from the originator to the BIO (17 ETA, 28 ADA). At time of switch, 12/17 patients on ETA and 18/28 on ADA were in remission. No significant difference has been found at 3, 6 and 12 months after the switch. Ten patients discontinued biosimilars due to disease remission (4 ETA, 3 ADA), family willing (1 ETA), occurrence of burning at injection site (1 ETA), and persistent activity (1 ADA). No statistically significant difference was observed between originator and BIOs, nor between originator and BIOs, and between ADA and ETA in time to disease remission achievement, time to relapse and number of patients who experienced AE. Conclusion Our real-life results seem to confirm the efficacy and safety profile of switching from originator of ADA and ETA to their respective BIOs also in paediatric patients with JIA.

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Section: Discussionsupporting

confidence: 89%

“…Something that might be interesting is that there is a slightly increased reporting of site injection reaction with biosimilars. This ADE was also reported in adult cohorts and seems to be correlated to the presence of citrate in biosimilars [40][41][42][43][44][45]. Furthermore, in our cohort there is not an increased rate of serious ADEs.…”

Section: Discussionsupporting

confidence: 84%

OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis

et al. 2021

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“…showed that 12/119 ETN/SB4 switching RA patients developed AEs at 6 month follow up. 24 Finally, a recent systematic review also addressed the issue of safety and found an incidence of AE around 34.2% in psoriatic ETN/SB4 patients, with 17.1% being infectious events. Comparable results were also reported by Ebbers et al .…”

Section: Discussionmentioning

confidence: 99%

“…12 In a Romanian national cohort study, Codreanu et al showed that 12/119 ETN/SB4 switching RA patients developed AEs at 6 month follow up. 24 Finally, a recent systematic review also addressed the issue of safety and found an incidence of AE around 34.2% in psoriatic ETN/SB4 patients, with 17.1% being infectious events. Comparable results were also reported by Ebbers et al 23 When considering AEs in detail, still the DANBIO registry reports that, in particular, a prevalence of joint disease flares after 3 months from switching ranged from 5% to 24% of patients, according to different disease specific definitions.…”

Section: Discussionmentioning

confidence: 99%

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

Bruni

Gentileschi

Pacini

et al. 2020

Therapeutic Advances in Musculoskeletal

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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.

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“…Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects between 0.5% and 1% of the general population. 1 , 2 Pharmacological treatment for RA includes using non-steroidal anti-inflammatory drugs, glucocorticoids, and synthetic or biologics disease-modifying anti-rheumatic drugs (DMARDs). The standard of care for RA patients who respond inadequately to synthetic DMARDs is to add a biological DMARD (biologics).…”

Section: Introductionmentioning

confidence: 99%

Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake?

Horta-Baas¹

2022

PROM

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Purpose This review aims to provide an overview of the impact of TNFis biosimilars, with marketing authorization, in patient-reported outcome measures (PROMs) scores and explore how PROMs endpoints might add value in biosimilars uptake in RA patients. Patients and Methods A comprehensive search of Medline, Scopus, Lilacs, and CINAHL databases was performed for papers published between January 2012 and December 2021. For inclusion, studies had to be prospective, published in a peer-reviewed journal, published in English or Spanish language; studies using PROMs as an outcome measure. After screening title and abstracts and assessing the remaining full texts fulfilling the inclusion criteria, 31 papers were used in this narrative review. Results PROMs were used as secondary outcomes in included studies. The most frequently employed domains to assess biosimilar efficacy include physical function, patient global assessment (PtGA), health-related quality of life (HRQoL), and fatigue. The results of randomized clinical trials uniformly showed that mean change in PROMs scores is comparable between biosimilar and reference biologic treatment groups. However, open-label and real-world studies revealed high rates of discontinuation of therapy, mainly for subjective worsening of disease activity or non-specific adverse events. Even without objective clinical evidence of inflammation, patients who are considered to have active disease (higher scores on PtGA) have higher discontinuation rates of biosimilars. The available information suggests that the nocebo effect is the most likely cause for the discontinuation of biosimilars. Conclusion There is scarce literature surrounding the impact of biosimilars in PROMs, especially in open-label studies. In real-life studies, biosimilars have a higher discontinuation rate than reference products. TNFis biosimilars treatment efficacy in RA depends on disease activity and other factors such as PtGA and fatigue. The nocebo effect is the best explanation for biosimilar’s discontinuation.

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Efficacy and safety of original and biosimilar etanercept (SB4) in active rheumatoid arthritis – A comparison in a real-world national cohort

Cited by 23 publications

References 24 publications

OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis

OBSIDIAN – real-world evidence of originator to biosimilar drug switch in juvenile idiopathic arthritis

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

Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake?

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