Abstract Background Biologic use in IBD is rapidly expanding in Serbia, yet real-world data on treatment patterns, outcomes, and service organization remain limited. BioTher (Biologic Therapy) is a care-embedded digital platform, initially implemented at a high-volume tertiary IBD centre, designed to support biologic scheduling, clinical monitoring, and drug logistics. Before national roll-out, we aimed to describe the current biologic-treated IBD population at this centre, characterize treatment patterns by drug and dosing protocol, and explore how BioTher data can inform future evaluation of treatment outcomes, biologic supply planning, and the epidemiological profiling of the IBD population in Serbia. Methods We performed a descriptive analysis of all adult IBD patients entered into BioTherand treated with biologics at a tertiary referral centre. The platform captures demographics, diagnosis, biologic agent, induction/maintenance protocol (label vs optimised), dates and doses of infusions/injections, and municipality/city of residence. We summarised patient numbers, sex distribution, Crohn’s disease vs ulcerative colitis, distribution by biologic class/agent, share of standard vs optimised regimens, and visit frequency. City- and region-level heatmaps were generated from residence data to visualise catchment areas and travel burden. Aggregated monthly biologic consumption curves were used to model future drug supply needs. Results BioTher currently includes 757 IBD patients, of whom 676 (89%) are actively treated with biologic or small-molecule therapy. Crohn’s disease accounts for ∼60% of active cases, with a male predominance, while ulcerative colitis shows a more balanced sex distribution. Vedolizumab and infliximab biosimilar are the most frequently used agents, and dose optimisation is required in a substantial share of patients, particularly for infliximab biosimilar and ustekinumab. Almost half of the cohort resides outside Belgrade, and the centre delivers over 5,000 biologic visits per year, underscoring high service throughput and highlighting clear opportunities for data-driven drug-supply planning and future decentralisation of care. Conclusion BioTher-Serbia is the first data warehouse software in Serbia. By combining digital care workflows, high-quality longitudinal data, and predictive modeling, it addresses both clinical and system-level gaps. When put on a national level, this initiative will strengthen national research capacity, support treat-to-target care, and contribute Eastern European real-world data to the ECCO community through alignment with UR-CARE. References: 1. Burisch J, et al. Validation of the United Registries for Clinical Assessment and Research (UR-CARE). J Crohns Colitis. 2018;12(5):532-539. 2. Kostić M, Djakovic L, Šujić R, et al. Inflammatory bowel diseases (Crohn’s disease and ulcerative colitis): cost of treatment in Serbia and the implications. Appl Health Econ Health Policy. 2017;15(1):85-93. 3. Rencz F, et al. Biological Therapy in Inflammatory Bowel Diseases: Access in Central and Eastern Europe. World J Gastroenterol. 2015;21(6):1728-1737. Conflict of interest: Dr. Knezevic, Tamara: nothing to declare Matic, Rade: No conflict of interest Odanovic, Olga: No conflict of interest Mitrovic, Milos: None Kalaba, Ana: No conflict of interest Kralj, Djordje: No conflict of interest Markovic, Srdjan: No conflict of interest
Knežević et al. (Thu,) studied this question.