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Effectiveness, safety and economic analysis of Benepali in clinical practice.
Rojas-Giménez, Marta; Mena-Vázquez, Natalia; Romero-Barco, Carmen María; Manrique-Arija, Sara; Ureña-Garnica, Inmaculada; Diaz-Cordovés, Gisela; Jiménez-Núñez, Francisco Gabriel; Fernández-Nebro, Antonio.
Afiliação
  • Rojas-Giménez M; Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain; UGC de Reumatología, Hospital Regional Universitario de Málaga, Málaga, Spain; UGC de Reumatología, Hospital Universitario Reina Sofía, Córdoba, Spain.
  • Mena-Vázquez N; Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain; UGC de Reumatología, Hospital Regional Universitario de Málaga, Málaga, Spain. Electronic address: nataliamenavazquez@gmail.com.
  • Romero-Barco CM; Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain; UGC de Reumatología, Hospital Virgen de la Victoria, Málaga, Spain.
  • Manrique-Arija S; Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain; UGC de Reumatología, Hospital Regional Universitario de Málaga, Málaga, Spain.
  • Ureña-Garnica I; Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain; UGC de Reumatología, Hospital Regional Universitario de Málaga, Málaga, Spain.
  • Diaz-Cordovés G; Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain; UGC de Reumatología, Hospital Regional Universitario de Málaga, Málaga, Spain.
  • Jiménez-Núñez FG; Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain; UGC de Reumatología, Hospital Regional Universitario de Málaga, Málaga, Spain.
  • Fernández-Nebro A; Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain; UGC de Reumatología, Hospital Regional Universitario de Málaga, Málaga, Spain; Departamento de Medicina, Universidad de Málaga, Málaga, Spain.
Reumatol Clin (Engl Ed) ; 17(10): 588-594, 2021 Dec.
Article em En | MEDLINE | ID: mdl-34823826
OBJECTIVE: To assess the effectiveness, safety and cost of Etanercept biosimilar in patients with rheumatoid arthritis (RA), spondyloarthritis (SpA) and psoriatic arthritis (PsA) compared to the standard drug in real clinical practice. PATIENTS AND METHODS: Retrospective observational study. Case series of 138 patients with RA, SpA or PsA treated with at least one dose of Benepali® (n = 79) or Enbrel® (n = 59). Drug retention time was the primary efficacy endpoint compared to the biosimilar and the original. The proportion of patients achieving low disease activity or remission after 52 weeks was used as the secondary outcome. Safety was assessed by means of the adverse effects incidence rate. A cost minimization analysis was performed. RESULTS: No differences were observed regarding treatment retention time between drugs (median [95% confidence interval, 95% CI] at 12.0 months [10.2-12.0] for the biosimilar and 12.0 months [12.0-12.0] for the original). Similar improvements, in terms of inflammatory activity and physical function, were obtained after 52 weeks except for patients with SpA and PsA who, in general, experienced improvements of BASDAI and ASDAS with the original compared with the biosimilar. No significant differences were observed in the total number of adverse effects (.43 events/patient-years versus the biosimilar and .53 versus the original). Using the biosimilar in place of the original drug resulted in a net savings of 118,383.55 € (1,747.20 €/patient-years) for the hospital. CONCLUSION: The biosimilar Benepali is as effective and safe as the original and much more cost-effective.
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Texto completo: 1 Temas: ECOS / Aspectos_gerais Bases de dados: MEDLINE Assunto principal: Artrite Reumatoide / Artrite Psoriásica / Antirreumáticos / Medicamentos Biossimilares Tipo de estudo: Evaluation_studies / Health_economic_evaluation / Observational_studies Limite: Humans Idioma: En Revista: Reumatol Clin (Engl Ed) Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Espanha

Texto completo: 1 Temas: ECOS / Aspectos_gerais Bases de dados: MEDLINE Assunto principal: Artrite Reumatoide / Artrite Psoriásica / Antirreumáticos / Medicamentos Biossimilares Tipo de estudo: Evaluation_studies / Health_economic_evaluation / Observational_studies Limite: Humans Idioma: En Revista: Reumatol Clin (Engl Ed) Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Espanha