Drug-utilization, pharmacoeconomics and safety of advanced therapy for the treatment of inflammatory bowel diseases: from traditional approaches to novel interplays among real-world data sources.

This PhD thesis investigates drug utilization, safety profiles, and pharmacoeconomic aspects of therapies used in the treatment of inflammatory bowel diseases, with a particular focus on advanced therapies such as biologics. By leveraging real-world data from healthcare administrative databases and spontaneous reporting systems, the research provides novel insights into treatment patterns, healthcare resource consumption, and economic burden in patients with Crohn’s disease and ulcerative colitis. The set of studies developed in this scientific project highlights a progressive shift toward early, intensive therapeutic strategies and underscore the role of real-world data in detecting clinical and systemic disparities. A protocol for integrating heterogeneous data sources is proposed to enhance pharmacovigilance activities, aiming to strengthen signal detection and assessment. The thesis offers a methodological contribution by integrating heterogeneous real-world data sources, generating evidence that is directly applicable to both clinical decision-making and health policy development. Overall, the findings support the development of more effective, sustainable, and patient-centered approaches in the management of inflammatory bowel diseases.