ABSTRACTS of ICPE 2022, the 38th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), Copenhagen, Denmark, 26–28 August, 2022

Background: Biologic drugs for ulcerative colitis are recommended \nwhen conventional therapy fails. Real-world studies may provide relevant \ninformation for the optimization of care. \nObjectives: The objective of the study was to describe drug-utilization \nand Regional Health System use in patients with ulcerative colitis new \nusers of advanced treatment (biologic drugs). \nMethods: This descriptive, retrospective cohort study (EUPAS40896) \nwas performed using Tuscan healthcare administrative databases: the \ndrug-reimbursement database and the registries of hospital discharges, \nemergency department (ED) admission and specialist visits. \nWe extracted patients with the date of the first dispensation of a biologic \ndrug (index date) recorded between January 2015 and \nDecember 2019. We created one cohort for each drug of interest. \nWe included also patients with: age ≥ 18; five years of data before \nthe index date (look-back period) at least one year of follow-up; UC \ndiagnosis OR UC co-payment exemption code in the look-back or in \nthe follow-up OR a gastroenterological visit in the year before the \nindex date. We described: drug-utilization (history of conventional \ntherapy use, treatment coverage and switch/swap events); the number \nof patients with at least one admission to ED or hospitalization \nand the time free from the first event recorded. \nResults: We analyzed four cohorts of new-users of adalimumab \n(N = 239), infliximab (N = 175), 110 golimumab (N = 110), vedolizumab \n(N = 107). Almost all patients were treated with conventional \ntherapy prior to biologics. Adalimumab cohort showed the lowest proportion \nof patients with history of other biologics (N = 37; 15%), while \nvedolizumab cohort had the highest (N = 69; 65%). The mean coverage \nof biologic therapy exceeds 100% of treatment's days, except for \ninfliximab (94%). Twenty-four patients (22%) new users of golimumab \nswitched to another biologic drug (mostly infliximab). Among the \nother cohorts, switch/swap events occurred in 22 (13%) infliximab \npatients, and in 26 (11%) and 8 (8%) adalimumab and vedolizumab \npatients, respectively. Vedolizumab and infliximab cohorts had the \nhighest proportion of patients with at least one ED access (N = 43; \n40%) and one hospitalization (N = 61; 35%), respectively. Overall, we \ndidn't find relevant difference between the cohorts in the use of \nhealthcare facilities. The time to the first ED admission ranged from \n140 days (±104.04) for infliximab users to 176 (±107.71) for adalimumab \nusers. \nConclusions: The use of biologics seems to be in line with clinical \nrecommendation, with adalimumab being the most widely used as \nfirst choice. The occurrence of ED accesses and hospitalizations was \nalmost similar among the new users of biologic drugs for ulcerative \ncolitis.