| Autor: |
Fernández-Cano MC; Gastroenterology and Hepatology Unit, Virgen de las Nieves University Hospital, 18014 Granada, Spain.; Doctoral Programme in Clinical Medicine and Public Health, Faculty of Medicine, University of Granada, 18012 Granada, Spain., Fernández-Cano AJ; Citizen Innovation Department, Consortium for Developing the Information and Knowledge Society in Andalusia 'Fernando de los Ríos', 18016 Granada, Spain., Martín-Rodríguez MM; Gastroenterology and Hepatology Unit, Virgen de las Nieves University Hospital, 18014 Granada, Spain., Sánchez-Capilla AD; Gastroenterology and Hepatology Unit, Virgen de las Nieves University Hospital, 18014 Granada, Spain., Cabello-Tapia MJ; Gastroenterology and Hepatology Unit, Virgen de las Nieves University Hospital, 18014 Granada, Spain., Redondo-Cerezo E; Gastroenterology and Hepatology Unit, Virgen de las Nieves University Hospital, 18014 Granada, Spain.; Doctoral Programme in Clinical Medicine and Public Health, Faculty of Medicine, University of Granada, 18012 Granada, Spain. |
| Abstrakt: |
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. |
