Background/Introduction: Biologic treatments for ulcerative colitis (UC) (adalimumab, infliximab, golimumab, vedolizumab) are recommended when failure with traditional therapies occurred [1, 2]. Real-world studies may provide important effectiveness and safety information for the optimization of care. Objective/Aim: The study aim is to describe the utilization of Regional Healthcare System (RHS) facilities of Tuscany (Italy), including Emergency Department (ED) admissions and hospitalizations for any causes, in new users of UC biologic therapies. Methods: A descriptive, retrospective cohort study (EUPAS40896) was performed using Tuscan healthcare administrative databases, namely the hospital discharge registry, the ED admission records and the drug-reimbursement database. We created four drug-users cohorts with the following inclusion criteria: first supply of a biologic therapy (one cohort for each of the four drugs of interest) from January 2015 to December 2019; C 18 years old; five years of history data (lookback period); at least one year of follow-up; UC diagnosis OR UC copayment exemption code in the look-back or in the follow-up OR a gastroenterological visit in the year before the first supply. We described the number of patients with at least one ED access and one hospitalization for any cause, the time to the first ED access and to hospitalization for any cause, and the main causes of ED access and hospitalization. Results: The new users of biologic therapies were: 239 adalimumab, 175 infliximab, 110 golimumab, 107 vedolizumab. In the one-year follow-up, patients with at least one ED access were: 85 (36%) adalimumab, 65 (37%) infliximab, 43 (43%) vedolizumab, 42 (38%) golimumab. The major causes of ED admission, not necessary drugrelated, were symptoms, sings, and ill-defined conditions (31 adalimumab, 27 infliximab and 25 golimumab) and injury and poisoning (31 adalimumab and 19 vedolizumab). In the 1-year follow-up, patients with at least one hospitalization were: 61 (35%) infliximab, 54 (26%) adalimumab, 33 (30%) golimumab, and 31 (29%) vedolizumab. Infectious and parasitic diseases were the major causes observed. The mean time to the first ED access and to the first hospitalization ranged from 140 days (infliximab) to 176 days (adalimumab) and from 139 days (golimumab) to 166 days (vedolizumab), respectively. Conclusion: The assessment of RHS showed that the occurrence of ED accesses and hospitalizations was almost similar among the new users of UC biologic therapies, while the time to the first ED and the first hospitalization modestly varied among the four cohorts.
Oral Presentation: Accesses to Emergency Department and Hospitalizations in New Users of Biologic Therapies for Ulcerative Colitis in Tuscany: The MICHELANGELO Study
Valdiserra, G.;Tillati, S.;Lorenzoni, V.;Turchetti, G.;Giometto, S.;Convertino, I.;Ferraro, S.;Cappello, E.;Fornai, M.;Lucenteforte, E.;Tuccori, M.
2021-01-01
Abstract
Background/Introduction: Biologic treatments for ulcerative colitis (UC) (adalimumab, infliximab, golimumab, vedolizumab) are recommended when failure with traditional therapies occurred [1, 2]. Real-world studies may provide important effectiveness and safety information for the optimization of care. Objective/Aim: The study aim is to describe the utilization of Regional Healthcare System (RHS) facilities of Tuscany (Italy), including Emergency Department (ED) admissions and hospitalizations for any causes, in new users of UC biologic therapies. Methods: A descriptive, retrospective cohort study (EUPAS40896) was performed using Tuscan healthcare administrative databases, namely the hospital discharge registry, the ED admission records and the drug-reimbursement database. We created four drug-users cohorts with the following inclusion criteria: first supply of a biologic therapy (one cohort for each of the four drugs of interest) from January 2015 to December 2019; C 18 years old; five years of history data (lookback period); at least one year of follow-up; UC diagnosis OR UC copayment exemption code in the look-back or in the follow-up OR a gastroenterological visit in the year before the first supply. We described the number of patients with at least one ED access and one hospitalization for any cause, the time to the first ED access and to hospitalization for any cause, and the main causes of ED access and hospitalization. Results: The new users of biologic therapies were: 239 adalimumab, 175 infliximab, 110 golimumab, 107 vedolizumab. In the one-year follow-up, patients with at least one ED access were: 85 (36%) adalimumab, 65 (37%) infliximab, 43 (43%) vedolizumab, 42 (38%) golimumab. The major causes of ED admission, not necessary drugrelated, were symptoms, sings, and ill-defined conditions (31 adalimumab, 27 infliximab and 25 golimumab) and injury and poisoning (31 adalimumab and 19 vedolizumab). In the 1-year follow-up, patients with at least one hospitalization were: 61 (35%) infliximab, 54 (26%) adalimumab, 33 (30%) golimumab, and 31 (29%) vedolizumab. Infectious and parasitic diseases were the major causes observed. The mean time to the first ED access and to the first hospitalization ranged from 140 days (infliximab) to 176 days (adalimumab) and from 139 days (golimumab) to 166 days (vedolizumab), respectively. Conclusion: The assessment of RHS showed that the occurrence of ED accesses and hospitalizations was almost similar among the new users of UC biologic therapies, while the time to the first ED and the first hospitalization modestly varied among the four cohorts.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
