Adalimumab Persistence and Its Biosimilar in Inflammatory Bowel Disease: A Real-World Study
Metadatos
Mostrar el registro completo del ítemAutor
Fernández Cano, María Carmen; Fernández Cano, Antonio Jesús; Martín Rodríguez, María del Mar; Sánchez-Capilla, Antonio Damián; Cabello Tapia, María José; Redondo Cerezo, EduardoEditorial
MDPI
Materia
Adalimumab Drug switching Multiswitching
Fecha
2024-01-18Referencia bibliográfica
Fernández-Cano, M.C.; Fernández-Cano, A.J.; Martín- Rodríguez, M.M.; Sánchez-Capilla, A.D.; Cabello-Tapia, M.J.; Redondo- Cerezo, E. Adalimumab Persistence and Its Biosimilar in Inflammatory Bowel Disease: A Real-World Study. J. Clin. Med. 2024, 13, 556. https://doi.org/10.3390/jcm13020556
Resumen
Adalimumab biosimilar experience is still recent. Interchangeability differences could
reduce persistence times. Our goal was to compare biosimilar persistence differences with a reference.
A retrospective observational study was performed in three groups divided according to the adalimumab
received. The primary outcome measure was persistence, represented with Kaplan–Meier
analysis, and we secondarily evaluated security, efficacy, and biomarkers. We obtained approval
from the regional ethical committee, and the study was conducted following the Helsinki Declaration
as revised in 2013. Data from 104 patients were collected: 50 received the biosimilar, 29 received the
reference, and 25 switched from the original to the biosimilar. After a follow-up of 12 months, the
biosimilar’s persistence was higher, without differences in mild adverse events per group. In contrast,
there were differences in severe events, with the switched group’s frequency being higher. Biomarkers
were reduced at similar proportions in all groups, and 43% had a clinical response at week 20 without
differences. Adalimumab biosimilars are a valuable option for IBD based on clinical equivalence that
are less expensive than the original drug. Their use does not have a detrimental influence on disease,
although there are a few nuances in terms of interchangeability. These results support increasing
confidence in using biosimilars, thus promoting the better sustainability of health systems.