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      Introducción de biosimilares anti-TNF e impacto económico en un hospital de tercer nivel Translated title: Introduction of anti-TNF biosimilars and economic impact in a third level hospital

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          Abstract

          Resumen Objetivos: Analizar la introducción de medicamentos biosimilares anti-TNF en primera línea para pacientes con artritis reumatoide (AR). Métodos: Estudio unicéntrico, retrospectivo y observacional en un hospital de tercer nivel. Se incluyeron pacientes con diagnóstico de AR tratados por primera vez con un fármaco biológico (biosimilar u original), entre febrero 2017-febrero 2021. Las variables de resultado recogidas fueron: porcentaje de pacientes que iniciaban tratamiento cada año con cada fármaco biológico y porcentaje de variación anual de utilización de fármacos anti-TNF que tenían biosimilar respecto al resto de alternativas. Resultados: 178 pacientes con diagnóstico de AR fueron tratados por primera vez con un fármaco biológico. Durante los dos primeros años de introducción de biosimilares, el porcentaje de pacientes con AR tratados en primera línea con adalimumab, infliximab y etanercept fue 23,9%, mientras que los dos últimos años aumentaron las prescripciones con estos fármacos, a pesar de la aparición de nuevos originales, de forma que durante el último año de estudio cubrían un 44,6% de las prescripciones. El uso de estos tres fármacos anti-TNF biosimilares en pacientes con AR ha supuesto un ahorro de 213.530 €. Conclusiones: En nuestro centro el uso de biosimilares antiTNF se ha consolidado en los dos últimos años, a pesar de la incorporación de nuevos originales en el tratamiento de la AR. Considerando las diferentes políticas de introducción de biosimilares existentes, sería interesante que se realizarán estudios similares en otras regiones de nuestro país para poder establecer que política de uso de biosimilares puede ser más aceptada.

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          Abstract Objectives: To analyze the introduction of first-line anti-TNF biosimilar drugs for patients with rheumatoid arthritis (RA). Methods: Single-center, retrospective, observational study in a tertiary hospital. Patients with a diagnosis of RA treated for the first time with a biologic drug (biosimilar or original) between February 2017-February 2021 were included. The outcome variables collected were: percentage of patients initiating treatment each year with each biologic drug and percentage of annual variation in the use of anti-TNF drugs that had a biosimilar with respect to the other alternatives. Results: 178 patients diagnosed with RA were treated for the first time with a biologic drug. During the first two years of the introduction of biosimilars, the percentage of RA patients treated first line with adalimumab, infliximab and etanercept was 23.9%, while in the last two years prescriptions with these drugs increased, despite the appearance of new originals, so that during the last year of the study they covered 44.6% of prescriptions. The use of these three biosimilar anti-TNF drugs in patients with RA has resulted in savings of 213,530 €. Conclusions: In our center, the use of anti-TNF biosimilars has been consolidated in the last two years, despite the incorporation of new originals in the treatment of RA. Considering the different existing biosimilar introduction policies, it would be interesting to carry out similar studies in other regions of our country in order to establish which biosimilar use policy may be more accepted.

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          Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis

          Objectives To inform the 2019 update of the European League against Rheumatism (EULAR) recommendations for the management of rheumatoid arthritis (RA). Methods A systematic literature research (SLR) to investigate the efficacy of any disease-modifying antirheumatic drug (DMARD) (conventional synthetic (cs)DMARD, biological (b) and biosimilar DMARD, targeted synthetic (ts)DMARD) or glucocorticoid (GC) therapy in patients with RA was done by searching MEDLINE, Embase and the Cochrane Library for articles published between 2016 and 8 March 2019. Results 234 abstracts were selected for detailed assessment, with 136 finally included. They comprised the efficacy of bDMARDs versus placebo or other bDMARDs, efficacy of Janus kinase (JAK) inhibitors (JAKi) across different patient populations and head-to-head of different bDMARDs versus JAKi or other bDMARDs. Switching of bDMARDs to other bDMARDs or tsDMARDs, strategic trials and tapering studies of bDMARDs, csDMARDs and JAKi were assessed. The drugs evaluated included abatacept, adalimumab, ABT-122, baricitinib, certolizumab pegol, SBI-087, CNTO6785, decernotinib, etanercept, filgotinib, golimumab, GCs, GS-9876, guselkumab, hydroxychloroquine, infliximab, leflunomide, mavrilimumab, methotrexate, olokizumab, otilimab, peficitinib, rituximab, sarilumab, salazopyrine, secukinumab, sirukumab, tacrolimus, tocilizumab, tofacitinib, tregalizumab, upadacitinib, ustekinumab and vobarilizumab. The efficacy of many bDMARDs and tsDMARDs was shown. Switching to another tumour necrosis factor inhibitor (TNFi) or non-TNFi bDMARDs after TNFi treatment failure is efficacious. Tapering of DMARDs is possible in patients achieving long-standing stringent clinical remission; in patients with residual disease activity (including patients in LDA) the risk of flares is increased during the tapering. Biosimilars are non-inferior to their reference products. Conclusion This SLR informed the task force regarding the evidence base of various therapeutic regimen for the development of the update of EULAR’s RA management recommendation.
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            To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry

            Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retention rates were compared with that of a historic cohort of ETA-treated patients. Switchers who resumed ETA treatment (back-switchers) were characterised. Observational cohort study based on the DANBIO registry. Treatment retention was explored by Kaplan-Meier plots and Cox regression (crude, adjusted). 1621 (79%) of 2061 ETA-treated patients switched to SB4. Disease activity was unchanged 3 months’ preswitch/postswitch. Non-switchers often received 25 mg ETA (ETA 25 mg pens/syringes and powder solution were still available). One-year adjusted retention rates were: non-switchers: 77% (95% CI: 72% to 82%)/switchers: 83% (79% to 87%)/historic cohort: 90% (88% to 92%). Patients not in remission had lower retention rates than patients in remission, both in switchers (crude HR 1.7 (1.3 to 2.2)) and non-switchers (2.4 (1.7 to 3.6)). During follow-up, 120 patients (7% of switchers) back-switched to ETA. Back-switchers’ clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective. Seventy-nine per cent of patients switched from ETA to SB4. After 1 year, adjusted treatment retention rates were lower in switchers versus the historic ETA cohort, but higher than in non-switchers. Withdrawal was more common in patients not in remission. The results suggest that switch outcomes in routine care are affected by patient-related factors and non-specific drug effects.
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              Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes

              Introduction To evaluate the possibility that switching from reference biologic medicines to biosimilars could lead to altered clinical outcomes, including enhanced immunogenicity, compromised safety, or diminished efficacy for patients, a systematic literature review was conducted of all switching studies between related biologics (including biosimilars). Methods A systematic search was conducted using the Medline® and Embase® databases up to 30 June 2017 employing specific medical subject heading terms. Additionally, the snowball method and a hand search were also applied. Publications were considered if they contained efficacy or safety information related to a switch from a reference medicine to a biosimilar. Non-English, non-human studies, editorials, notes, and short surveys were excluded. Results Primary data were available from 90 studies that enrolled 14,225 unique individuals. They included protein medicines used in supportive care as well as those used as therapeutic agents. The medicines contained seven different molecular entities that were used to treat 14 diseases. The great majority of the publications did not report differences in immunogenicity, safety, or efficacy. The nature and intensity of safety signals reported after switching from reference medicines to biosimilars were the same as those already known from continued use of the reference medicines alone. Three large multiple switch studies with different biosimilars did not show differences in efficacy or safety after multiple switches between reference medicine and biosimilar. Two publications reported a loss of efficacy or increased dropout rates. Conclusions While use of each biologic must be assessed individually, these results provide reassurance to healthcare professionals and the public that the risk of immunogenicity-related safety concerns or diminished efficacy is unchanged after switching from a reference biologic to a biosimilar medicine. Electronic supplementary material The online version of this article (10.1007/s40265-018-0881-y) contains supplementary material, which is available to authorized users.
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                Author and article information

                Journal
                ofil
                Revista de la OFIL
                Rev. OFIL·ILAPHAR
                Organización de Farmacéuticos Ibero-Latinoamericanos (Madrid, Madrid, Spain )
                1131-9429
                1699-714X
                June 2023
                : 33
                : 2
                : 134-140
                Affiliations
                [1] Santander orgnameHospital Universitario Marqués de Valdecilla orgdiv1Servicio de Farmacia España
                Article
                S1699-714X2023000200007 S1699-714X(23)03300200007
                10.4321/s1699-714x2023000200007
                beadfa5a-b65b-4f5c-8535-8d85436c0927

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 24 June 2021
                : 03 August 2021
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 25, Pages: 7
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                SciELO Spain

                Categories
                Originales

                infliximab,adalimumab,rheumatoid arthritis,tumor necrosis factor inhibitors,Biosimilar,etanercept,inhibidores factor de necrosis tumoral,artritis reumatoide

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