Adalimumab Persistence and Its Biosimilar in Inflammatory Bowel Disease: A Real-World Study
María Carmen Fernández-Cano1,2, Antonio Jesús Fernández-Cano3, María Mar Martín-Rodríguez1
1Gastroenterology and Hepatology Unit, Virgen de las Nieves University Hospital, 18014 Granada, Spain.
Abstract:
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.
Insights
Adalimumab biosimilars demonstrate comparable efficacy and safety to the reference product. Persistence was higher with the biosimilar, though switching groups experienced more severe events, supporting biosimilar use in IBD management.
Area of Science:
- Gastroenterology and Hepatology
- Immunology
- Pharmacology
Background:
- Adalimumab biosimilars are emerging therapeutic options for inflammatory bowel disease (IBD).
- Understanding biosimilar persistence and interchangeability is crucial for clinical practice and healthcare sustainability.
Purpose of the Study:
- To compare the persistence of adalimumab biosimilars versus the reference product in IBD patients.
- To evaluate safety, efficacy, and biomarker profiles across different adalimumab formulations.
Main Methods:
- Retrospective observational study involving 104 IBD patients.
- Three groups: adalimumab biosimilar, reference adalimumab, and patients switching from reference to biosimilar.
- Primary outcome: persistence assessed by Kaplan-Meier analysis over 12 months. Secondary outcomes: safety, efficacy, and biomarkers.
Main Results:
- Biosimilar persistence was higher than the reference product over 12 months.
- No significant differences in mild adverse events or clinical response rates (43% at week 20).
- The group switching to the biosimilar experienced a higher frequency of severe adverse events.
Conclusions:
- Adalimumab biosimilars are clinically equivalent and cost-effective alternatives for IBD management.
- While generally safe and effective, careful consideration of interchangeability is needed, particularly for patients switching formulations.
- Increased confidence in biosimilar use can enhance the sustainability of healthcare systems.
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