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dc.contributor.authorSchmalzing, Marc
dc.contributor.authorKellner, Herbert
dc.contributor.authorAskari, Ayman
dc.contributor.authorDe-Toro, Javier
dc.contributor.authorVázquez Pérez-Coleman, Julio César
dc.contributor.authorFoti, Rosario
dc.contributor.authorJeka, Sławomir
dc.contributor.authorHaraoui, Boulos
dc.contributor.authorAllanore, Yannick
dc.contributor.authorPeichl, Peter
dc.contributor.authorOehri, Martin
dc.contributor.authorRahman, Masiur
dc.contributor.authorFurlan, Fabricio
dc.contributor.authorRomero, Elisa
dc.contributor.authorHachaichi, Sohaib
dc.contributor.authorBoth, Charlotte
dc.contributor.authorBruekmann, Ines
dc.contributor.authorSheeran, Tom
dc.date.accessioned2024-06-14T07:31:46Z
dc.date.available2024-06-14T07:31:46Z
dc.date.issued2023-11-11
dc.identifier.citationSchmalzing M, Kellner H, Askari A, De Toro Santos J, Vazquez Perez-Coleman JC, Foti R, Jeka S, Haraoui B, Allanore Y, Peichl P, Oehri M, Rahman M, Furlan F, Romero E, Hachaichi S, Both C, Brueckmann I, Sheeran T. Real-world effectiveness and safety of SDZ ETN, an etanercept biosimilar, in patients with rheumatic diseases: final results from multi-country COMPACT study. Adv Ther. 2024 Jan;41(1):315-330.es_ES
dc.identifier.issn0741-238X
dc.identifier.urihttp://hdl.handle.net/2183/36920
dc.description.abstract[Abstract] Introduction: COMPACT, a non-interventional study, evaluated the persistence, effectiveness, safety and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA), axial-spondyloarthritis (axSpA) or psoriatic arthritis (PsA) treated with SDZ ETN (etanercept [ETN] biosimilar) in Europe and Canada. Methods: Patients (aged ≥ 18 years) who have been treated with SDZ ETN were categorised on the basis of prior treatment status (groups A-D): patients in clinical remission or with low disease activity under treatment with reference ETN or biosimilar ETN and switched to SDZ ETN; patients who received non-ETN targeted therapies and switched to SDZ ETN; biologic-naïve patients who started SDZ ETN after conventional therapy failure; or disease-modifying anti-rheumatic drug (DMARD)-naïve patients with RA considered suitable for treatment initiation with a biologic and started on treatment with SDZ ETN. The primary endpoint was drug persistence, defined as time from study enrolment until discontinuation of SDZ ETN treatment. Results: Of the 1466 patients recruited, 844 (57.6%) had RA, 334 (22.8%) had axSpA and 288 (19.6%) had PsA. Patients had an ongoing SDZ ETN treatment at the time of enrolment for an observed average of 138 days (range 1-841); 22.7% of patients discontinued SDZ ETN through 12 months of study observation. Overall, all the patients receiving SDZ ETN showed good treatment persistence at 12 months with discontinuation rates of 15.2%, 25.7% and 27.8% in groups A, B and C, respectively. Across all patient groups, no major differences were observed in the disease activity and PRO scores between baseline and month 12. Injection-site reactions were low across the treatment groups. Conclusion: These results support the effectiveness and safety of SDZ ETN treatment in patients with RA, axSpA or PsA in real-life conditions. The treatment persistence rates observed were consistent with previously published reports of patients treated with reference or other biosimilar ETN. No new safety signals were identified.es_ES
dc.language.isospaes_ES
dc.publisherSpringer Naturees_ES
dc.relation.urihttps://doi.org/10.1007/s12325-023-02706-8es_ES
dc.rightsCreative Commons Attribution-NonCommercial 4.0 International License (CC-BY-NC 4.0)es_ES
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/*
dc.subjectBiosimilares_ES
dc.subjectCOMPACTes_ES
dc.subjectEffectivenesses_ES
dc.subjectNon-interventionales_ES
dc.subjectPROes_ES
dc.subjectPersistencees_ES
dc.subjectReal-worldes_ES
dc.subjectRheumatic diseaseses_ES
dc.subjectSDZ ETNes_ES
dc.subjectSafetyes_ES
dc.titleReal-world effectiveness and safety of SDZ ETN, an etanercept biosimilar, in patients with rheumatic diseases: final results from multi-country COMPACT studyes_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.rights.accessinfo:eu-repo/semantics/openAccesses_ES
UDC.journalTitleAdvances in Therapyes_ES
UDC.volume41es_ES
UDC.startPage315es_ES
UDC.endPage330es_ES
dc.identifier.doi10.1007/s12325-023-02706-8


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