Publish in this journal
Journal Information
Share
Share
Download PDF
More article options
ePub
Visits
...
Original Article
DOI: 10.1016/j.reumae.2020.06.010
Available online 16 March 2021
Effectiveness, safety and economic analysis of Benepali in clinical practice
Efectividad, seguridad y análisis económico de Benepali en práctica clínica
Visits
...
Marta Rojas-Giméneza,b,c, Natalia Mena-Vázqueza,b,
Corresponding author
nataliamenavazquez@gmail.com

Corresponding author.
, Carmen María Romero-Barcoa,d, Sara Manrique-Arijaa,b, Inmaculada Ureña-Garnicaa,b, Gisela Diaz-Cordovésa,b, Francisco Gabriel Jiménez-Núñeza,b, Antonio Fernández-Nebroa,b,e
a Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain
b UGC de Reumatología, Hospital Regional Universitario de Málaga, Málaga, Spain
c UGC de Reumatología, Hospital Universitario Reina Sofía, Córdoba, Spain
d UGC de Reumatología, Hospital Virgen de la Victoria, Málaga, Spain
e Departamento de Medicina, Universidad de Málaga, Málaga, Spain
Received 04 February 2020. Accepted 29 June 2020
Article information
Abstract
Full Text
Bibliography
Download PDF
Statistics
Tables (3)
Table 1. Baseline characteristics of the patients.
Table 2. Effectiveness data of both drugs.
Table 3. Comparison of adverse effects of the biosimilar (BS) and the original drug.
Show moreShow less
Abstract
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.

Keywords:
Rheumatic disease
Disease-modifying anti-rheumatic drugs
Biologic therapy
Pharmacoeconomics
Resumen
Objetivo

Evaluar la efectividad, la seguridad y los costes de etanercept biosimilar (BS) en pacientes con artritis reumatoide (AR), espondiloartritis (EspA) y artritis psoriásica (APs) y en comparación con su original, en condiciones de práctica clínica habitual.

Pacientes y métodos

Estudio observacional retrospectivo. Se incluyeron 138 pacientes con AR, EspA o APs tratados con al menos una dosis de Benepali® (n = 79) o Enbrel® (n = 59). Como desenlace principal de efectividad del BS o de su original se usó el tiempo de retención del fármaco. Como desenlace secundario de efectividad se midió la proporción de pacientes que alcanzaban baja actividad o remisión a las 52 semanas. La seguridad fue evaluada mediante tasas de incidencia de efectos adversos. Se hizo un análisis de minimización de costes.

Resultados

No se observaron diferencias en cuanto a retención del tratamiento (mediana [intervalo de confianza del 95%, IC 95%] de 12,0 meses [10,2–12,0] para BS y 12,0 meses [12,0–12,0] para el original). Se obtuvieron mejorías similares después de 52 semanas en actividad inflamatoria y función física, excepto en los pacientes con EspA y APs, que en general obtuvieron mejores valores de BASDAI y ASDAS con el BS. No se registraron diferencias en el número total de efectos adversos (0,43 eventos/pacientes-año con BS frente a 0,53 con original). El uso del BS, en lugar de su original, supuso un ahorro neto para el centro de 118.383,55 € (1.747,2€/pacientes-año).

Conclusiones

El uso del BS parece tan eficaz y seguro como su original y mucho más coste-efectivo.

Palabras clave:
Enfermedades reumáticas
Fármacos modificadores de la enfermedad
Terapia biológica
Análisis farmacoeconómico

Article

These are the options to access the full texts of the publication Reumatología Clínica (English Edition)
Member
If you are member of Sociedad Española de Reumatología (SER) or the Colegio Mexicano de Reumatología (CMR):
Please go to the member area of SER or CMR and log in.
Subscriber
Subscriber

If you already have your login data, please click here .

If you have forgotten your password you can you can recover it by clicking here and selecting the option “I have forgotten my password”
Subscribe
Subscribe to

Reumatología Clínica (English Edition)

Purchase
Purchase article

Purchasing article the PDF version will be downloaded

Price 19.34 €

Purchase now
Contact
Phone for subscriptions and reporting of errors
From Monday to Friday from 9 a.m. to 6 p.m. (GMT + 1) except for the months of July and August which will be from 9 a.m. to 3 p.m.
Calls from Spain
932 415 960
Calls from outside Spain
+34 932 415 960
Email
Idiomas
Reumatología Clínica (English Edition)

Subscribe to our newsletter

Article options
Tools
es en

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?