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Real-world effectiveness and safety of SDZ ETN, an etanercept biosimilar, in patients with rheumatic diseases: final results from multi-country COMPACT study
dc.contributor.author | Schmalzing, Marc | |
dc.contributor.author | Kellner, Herbert | |
dc.contributor.author | Askari, Ayman | |
dc.contributor.author | De-Toro, Javier | |
dc.contributor.author | Vázquez Pérez-Coleman, Julio César | |
dc.contributor.author | Foti, Rosario | |
dc.contributor.author | Jeka, Slawomir | |
dc.contributor.author | Haraoui, Boulos | |
dc.contributor.author | Allanore, Yannick | |
dc.contributor.author | Peichl, Peter | |
dc.contributor.author | Oehri, Martin | |
dc.contributor.author | Rahman, Masiur | |
dc.contributor.author | Furlan, Fabricio | |
dc.contributor.author | Romero, Elisa | |
dc.contributor.author | Hachaichi, Sohaib | |
dc.contributor.author | Both, Charlotte | |
dc.contributor.author | Brueckmann, Ines | |
dc.contributor.author | Sheeran, Tom | |
dc.date.accessioned | 2024-05-16T07:31:28Z | |
dc.date.available | 2024-05-16T07:31:28Z | |
dc.date.issued | 2023-11-11 | |
dc.identifier.citation | Schmalzing 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. RReal-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.issn | 0741-238X | |
dc.identifier.uri | http://hdl.handle.net/2183/36495 | |
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.iso | eng | es_ES |
dc.publisher | Springer Nature | es_ES |
dc.relation.uri | https://doi.org/10.1007/s12325-023-02706-8 | es_ES |
dc.rights | Creative Commons Attribution-NonCommercial 4.0 International License (CC-BY-NC 4.0) | es_ES |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ | * |
dc.subject | Biosimilar | es_ES |
dc.subject | COMPACT | es_ES |
dc.subject | Effectiveness | es_ES |
dc.subject | Non-interventional | es_ES |
dc.subject | PRO | es_ES |
dc.subject | Persistence | es_ES |
dc.subject | Real-world | es_ES |
dc.subject | Rheumatic diseases | es_ES |
dc.subject | SDZ ETN | es_ES |
dc.subject | Safety | es_ES |
dc.title | Real-world effectiveness and safety of SDZ ETN, an etanercept biosimilar, in patients with rheumatic diseases: final results from multi-country COMPACT study | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.rights.access | info:eu-repo/semantics/openAccess | es_ES |
UDC.journalTitle | Advances in Therapy | es_ES |
UDC.volume | 41 | es_ES |
UDC.startPage | 315 | es_ES |
UDC.endPage | 330 | es_ES |
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