Background/Introduction: In Europe, JAKi were approved for rheumatoid arthritis (RA) in 2018 [1, 2]. Post-marketing surveillance is crucial to confirm utilization and safety [3]. Objective/Aim: This study is aimed at observing Regional Healthcare Service utilization as proxy of disease burden and safety of new JAKi RA users in the immediate post-approval period by using Tuscan real-world data. We described Emergency Department (ED) accesses and hospitalizations for any causes and RA visits both before and after the treatment initiation. Methods: We performed a retrospective cohort study using Tuscan data of different healthcare administrative databases, i.e. repositories of drug-supplying, ED admissions, hospitalizations, and specialist visits (EUPAS35746). Two cohorts were selected: (1) the first had a JAKi first-ever supply from January 2018 to December 2019, (2) the second from January 2018 to June 2019. We included Tuscan adult patients with at least 10 years of data before the cohort entry. In the first cohort, we calculated the number of ED accesses and hospitalizations for any causes, and RA visits recorded in the five years preceding the first-ever JAKi supply, while in the second, these events were assessed in the six months of follow-up. The mean time and standard deviation (SD) to events were estimated. Results: The first cohort included 363 new JAKi-users. The median age was 63 years (interquartile range, IQR 52.5–71.5). Females were 293 (80.7%). Baricitinib was supplied to 285 (78.5%) patients and tofacitinib to 78 (21.5%). The mean number of the investigated events per patient/year slightly increased from the fifth to the first year before the JAKi supply: ED accesses rose from 0.47 to 0.56, hospitalizations from 0.23 to 0.31, and RA visits from 1.02 to 1.19. The second cohort, made up of 220 new JAKi-users, included 179 (81.4%) females. Tofacitinib was supplied to 42 (19.1%) patients while baricitinib to 178 (80.9%). The median age was 62.0 (IQR 53.0–71.0). In the follow- up, 54 (24.5%) patients had ED admissions, 28 (12.7%) hospitalizations, and 38 (17.3%) RA visits. Not all these events were necessarily drug-related. The mean time to the first ED access was 73.5 days (SD 54.1), to hospitalization 89.6 days (SD 54.8), and to RA visit 60.9 days (SD 51.3). The causes most frequently associated with hospitalizations were cardiovascular (69.2%) and musculoskeletal disorders (64.1%), while those reported to ED accesses were injury and poisoning (18.3%), and skin disorders (13.8%). Conclusion: The healthcare service utilization and related causes were in line with the JAKi safety profile and the underline disease.
Assessment of Healthcare Facilities Associated with JAKi Drugs Used in Rheumatoid Arthritis Patients in Tuscany, Italy: The LEONARDO
Valdiserra, G.;Convertino, I.;Giometto, S.;Lorenzoni, V.;Turchetti, G.;Fini, E.;Ferraro, S.;Cappello, E.;Blandizzi, C.;Lucenteforte, E.;Tuccori, M.
2021-01-01
Abstract
Background/Introduction: In Europe, JAKi were approved for rheumatoid arthritis (RA) in 2018 [1, 2]. Post-marketing surveillance is crucial to confirm utilization and safety [3]. Objective/Aim: This study is aimed at observing Regional Healthcare Service utilization as proxy of disease burden and safety of new JAKi RA users in the immediate post-approval period by using Tuscan real-world data. We described Emergency Department (ED) accesses and hospitalizations for any causes and RA visits both before and after the treatment initiation. Methods: We performed a retrospective cohort study using Tuscan data of different healthcare administrative databases, i.e. repositories of drug-supplying, ED admissions, hospitalizations, and specialist visits (EUPAS35746). Two cohorts were selected: (1) the first had a JAKi first-ever supply from January 2018 to December 2019, (2) the second from January 2018 to June 2019. We included Tuscan adult patients with at least 10 years of data before the cohort entry. In the first cohort, we calculated the number of ED accesses and hospitalizations for any causes, and RA visits recorded in the five years preceding the first-ever JAKi supply, while in the second, these events were assessed in the six months of follow-up. The mean time and standard deviation (SD) to events were estimated. Results: The first cohort included 363 new JAKi-users. The median age was 63 years (interquartile range, IQR 52.5–71.5). Females were 293 (80.7%). Baricitinib was supplied to 285 (78.5%) patients and tofacitinib to 78 (21.5%). The mean number of the investigated events per patient/year slightly increased from the fifth to the first year before the JAKi supply: ED accesses rose from 0.47 to 0.56, hospitalizations from 0.23 to 0.31, and RA visits from 1.02 to 1.19. The second cohort, made up of 220 new JAKi-users, included 179 (81.4%) females. Tofacitinib was supplied to 42 (19.1%) patients while baricitinib to 178 (80.9%). The median age was 62.0 (IQR 53.0–71.0). In the follow- up, 54 (24.5%) patients had ED admissions, 28 (12.7%) hospitalizations, and 38 (17.3%) RA visits. Not all these events were necessarily drug-related. The mean time to the first ED access was 73.5 days (SD 54.1), to hospitalization 89.6 days (SD 54.8), and to RA visit 60.9 days (SD 51.3). The causes most frequently associated with hospitalizations were cardiovascular (69.2%) and musculoskeletal disorders (64.1%), while those reported to ED accesses were injury and poisoning (18.3%), and skin disorders (13.8%). Conclusion: The healthcare service utilization and related causes were in line with the JAKi safety profile and the underline disease.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
