Real-world effectiveness and persistence of reference etanercept versus biosimilar etanercept GP2015 among rheumatoid arthritis patients: A cohort study

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  • dc.contributor.author Carballo Martínez, Núria
  • dc.contributor.author Pérez-García, Carolina
  • dc.contributor.author Grau Cerrato, Santiago
  • dc.contributor.author Monfort, Jordi
  • dc.contributor.author Duran Jordà, Xavier, 1974-
  • dc.contributor.author Echeverría Esnal, Daniel
  • dc.contributor.author Ferrández, Olivia
  • dc.date.accessioned 2023-04-05T06:15:53Z
  • dc.date.available 2023-04-05T06:15:53Z
  • dc.date.issued 2022
  • dc.description.abstract Although several randomized clinical trials have confirmed that there is no difference in efficacy between etanercept and its biosimilar versions in the treatment of rheumatoid arthritis (RA), limited real-world evidence is available. We conducted a cohort study to compare the effectiveness and treatment persistence between the reference etanercept (ETN) and the biosimilar GP2015 in RA patients in a real-life setting. Adults with a diagnosis of RA who initiated treatment with ETN or GP2015, between January 2007 and December 2019, were included. The follow-up period was 52 weeks. The primary outcome was the mean of change in the DAS28-CRP values and the adjusted mean difference from baseline to 52 weeks between ETN and GP2015. Other effectiveness endpoints assessed were the rate of patients who achieved remission or low disease activity (LDA) at week 52, who showed a reduction of DAS28-CRP value greater than or equal to 1.2 from baseline to week 52 and rate of good responder patients (those meeting both effectiveness measures) at week 52. Treatment effectiveness over time (baseline, 26 and 52 weeks) was compared between the ETN and GP2015 groups using mixed effects models. Treatment persistence (probability of maintaining the same treatment over time) was also evaluated and shown using Kaplan-Meier survival curves. A total of 115 RA patients were included (ETN, n = 90; GP2015, n = 25). No differences were observed in the primary outcome: DAS28-CRP score decreased from baseline to week 52 [5.1 to 2.7 (mean of change -2.37) in ETN group and 5.0 to 2.2 (mean of change -2.84) in GP2015 group, p-value = 0.372] and the adjusted mean difference was -0.37 (-1.03 to 0.29). No differences were also observed in the other effectiveness endpoints assessed among patients treated with ETN or GP2015: rate of patients who achieved remission (54.1% vs. 66.7%, p-value = 0.303) and LDA (71.6% vs. 80.9%, p-value = 0.391) at week 52, reduction of DAS28-CRP value greater than or equal to 1.2 from baseline to week 52 (75.6% vs. 80.9%, p-value = 0.613) and rate of good responder patients (58.1% vs. 76.1%, p-value = 0.202). Drug survival was 82% and 80% for ETN and GP2015, respectively (log-rank p-value = 0.804). Etanercept and its biosimilar GP2015 show similar effectiveness and treatment persistence in RA patients in a real-life setting.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Carballo N, Pérez García C, Grau S, Monfort J, Durán-Jordà X, Echeverría-Esnal D, Ferrández O. Real-world effectiveness and persistence of reference etanercept versus biosimilar etanercept GP2015 among rheumatoid arthritis patients: A cohort study. Front Pharmacol. 2022 Oct 3;13:980832. DOI: 10.3389/fphar.2022.980832
  • dc.identifier.doi http://dx.doi.org/10.3389/fphar.2022.980832
  • dc.identifier.issn 1663-9812
  • dc.identifier.uri http://hdl.handle.net/10230/56410
  • dc.language.iso eng
  • dc.publisher Frontiers
  • dc.relation.ispartof Front Pharmacol. 2022 Oct 3;13:980832
  • dc.rights © 2022 Carballo, Pérez García, Grau, Monfort, Durán-Jordà, Echeverría-Esnal and Ferrández. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by/4.0/
  • dc.subject.keyword GP2015
  • dc.subject.keyword Biosimilar agents
  • dc.subject.keyword Drug survival real-life data
  • dc.subject.keyword Effectivenes
  • dc.subject.keyword Etanercept (enbrel)
  • dc.subject.keyword Rheumatoid anhritis
  • dc.title Real-world effectiveness and persistence of reference etanercept versus biosimilar etanercept GP2015 among rheumatoid arthritis patients: A cohort study
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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