Background: Biologic drugs for ulcerative colitis are recommended when conventional therapy fails. Real-world studies may provide relevant information for the optimization of care. Objectives: The objective of the study was to describe drug-utilization and Regional Health System use in patients with ulcerative colitis new users of advanced treatment (biologic drugs). Methods: This descriptive, retrospective cohort study (EUPAS40896) was performed using Tuscan healthcare administrative databases: the drug-reimbursement database and the registries of hospital discharges, emergency department (ED) admission and specialist visits. We extracted patients with the date of the first dispensation of a biologic drug (index date) recorded between January 2015 and December 2019. We created one cohort for each drug of interest. We included also patients with: age ≥ 18; five years of data before the index date (look-back period) at least one year of follow-up; UC diagnosis OR UC co-payment exemption code in the look-back or in the follow-up OR a gastroenterological visit in the year before the index date. We described: drug-utilization (history of conventional therapy use, treatment coverage and switch/swap events); the number of patients with at least one admission to ED or hospitalization and the time free from the first event recorded. Results: We analyzed four cohorts of new-users of adalimumab (N = 239), infliximab (N = 175), 110 golimumab (N = 110), vedolizumab (N = 107). Almost all patients were treated with conventional therapy prior to biologics. Adalimumab cohort showed the lowest proportion of patients with history of other biologics (N = 37; 15%), while vedolizumab cohort had the highest (N = 69; 65%). The mean coverage of biologic therapy exceeds 100% of treatment's days, except for infliximab (94%). Twenty-four patients (22%) new users of golimumab switched to another biologic drug (mostly infliximab). Among the other cohorts, switch/swap events occurred in 22 (13%) infliximab patients, and in 26 (11%) and 8 (8%) adalimumab and vedolizumab patients, respectively. Vedolizumab and infliximab cohorts had the highest proportion of patients with at least one ED access (N = 43; 40%) and one hospitalization (N = 61; 35%), respectively. Overall, we didn't find relevant difference between the cohorts in the use of healthcare facilities. The time to the first ED admission ranged from 140 days (±104.04) for infliximab users to 176 (±107.71) for adalimumab users. Conclusions: The use of biologics seems to be in line with clinical recommendation, with adalimumab being the most widely used as first choice. The occurrence of ED accesses and hospitalizations was almost similar among the new users of biologic drugs for ulcerative colitis.
Evaluation of drug-utilization and healthcare facilities use in patients with ulcerative colitis and treated with biologic therapy using data of an Italian healthcare administrative database: Results from michelangelo study
Ferraro, Sara;Giometto, Sabrina;Tillati, Silvia;Convertino, Irma;Valdiserra, Giulia;Cappello, Emiliano;Bonaso, Marco;Lorenzoni, Valentina;Turchetti, Giuseppe;Fornai, Matteo;Lucenteforte, Ersilia;Tuccori, Marco
2022-01-01
Abstract
Background: Biologic drugs for ulcerative colitis are recommended when conventional therapy fails. Real-world studies may provide relevant information for the optimization of care. Objectives: The objective of the study was to describe drug-utilization and Regional Health System use in patients with ulcerative colitis new users of advanced treatment (biologic drugs). Methods: This descriptive, retrospective cohort study (EUPAS40896) was performed using Tuscan healthcare administrative databases: the drug-reimbursement database and the registries of hospital discharges, emergency department (ED) admission and specialist visits. We extracted patients with the date of the first dispensation of a biologic drug (index date) recorded between January 2015 and December 2019. We created one cohort for each drug of interest. We included also patients with: age ≥ 18; five years of data before the index date (look-back period) at least one year of follow-up; UC diagnosis OR UC co-payment exemption code in the look-back or in the follow-up OR a gastroenterological visit in the year before the index date. We described: drug-utilization (history of conventional therapy use, treatment coverage and switch/swap events); the number of patients with at least one admission to ED or hospitalization and the time free from the first event recorded. Results: We analyzed four cohorts of new-users of adalimumab (N = 239), infliximab (N = 175), 110 golimumab (N = 110), vedolizumab (N = 107). Almost all patients were treated with conventional therapy prior to biologics. Adalimumab cohort showed the lowest proportion of patients with history of other biologics (N = 37; 15%), while vedolizumab cohort had the highest (N = 69; 65%). The mean coverage of biologic therapy exceeds 100% of treatment's days, except for infliximab (94%). Twenty-four patients (22%) new users of golimumab switched to another biologic drug (mostly infliximab). Among the other cohorts, switch/swap events occurred in 22 (13%) infliximab patients, and in 26 (11%) and 8 (8%) adalimumab and vedolizumab patients, respectively. Vedolizumab and infliximab cohorts had the highest proportion of patients with at least one ED access (N = 43; 40%) and one hospitalization (N = 61; 35%), respectively. Overall, we didn't find relevant difference between the cohorts in the use of healthcare facilities. The time to the first ED admission ranged from 140 days (±104.04) for infliximab users to 176 (±107.71) for adalimumab users. Conclusions: The use of biologics seems to be in line with clinical recommendation, with adalimumab being the most widely used as first choice. The occurrence of ED accesses and hospitalizations was almost similar among the new users of biologic drugs for ulcerative colitis.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
