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.

PubMed

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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