Real‑world safety and efficacy of biological agents in inflammatory bowel disease: a one-year post-marketing pharmacovigilance observational study in the Calabria region.

Background: The use of immune-modifying biological agents has markedly changed the clinical course and the management of inflammatory bowel diseases (IBDs). Active post-marketing surveillance programs are essential for the early recognition of both expected and unexpected adverse events (AEs), providing a powerful tool for better defining the safety profiles of biologics in a real-world setting.

Methods: Patients diagnosed with IBDs and treated with biologic drugs at two gastroenterology units in Calabria, Italy, were monitored during the period from 2023 to 2024.