OBJECTIVES: This real-world analysis evaluated the persistence and healthcare direct costs in Crohn's Disease(CD) patients undergoing biologic treatments, in the Italian clinical practice.

METHODS: A retrospective analysis on administrative databases of Italian healthcare-entities, covering 10.4mln health-assisted individuals, was performed. Adult CD-patients, biologic-treated throughout 2015-2020, were identified by ≥1 hospitalization(ICD-9-CM:555) or exemption code(009.555) and included. Patients were attributed to first/second treatment-line based on absence/presence of biologic prescriptions 5-years before index-date (i.e. first biologic prescription’ date). Survival curves were built evaluating drug-discontinuation, meant as duration of therapy until discontinuation within the "grace-period" (twice the prescriptions interval, according to SmPC posology). Healthcare direct-costs [drugs (ex-factory prices), hospitalizations, tests/visits] were assessed one-year after the index-date. A multivariate model was performed for drug discontinuation by adjusting baseline variables.

RESULTS: 1,398 CD patients were included, of which 89.8%(N=1,256) in first [adalimumab(N=802), infliximab(N=361), vedolizumab(N=89), ustekinumab(N=52), during follow-up] and 9.7%(N=135) in second-line [adalimumab(N=144), infliximab(N=96), vedolizumab(N=86), ustekinumab(N=110), during follow-up]. A higher persistence for ustekinumab versus infliximab, vedolizumab and adalimumab, both in first and second-line was found. Considering baseline variables and adalimumab as reference, infliximab in first-line(HR:0.537) and ustekinumab in first(HR:0.057) and second-line(HR:0.213) were associated with a significant lower risk of drug-discontinuation; vedolizumab showed no statistical significant difference. First-line total/average healthcare direct-costs equal €11,201, €13,636, €17,104 and €18,339 in patients treated with infliximab, adalimumab, ustekinumab and vedolizumab, respectively; in second line, 12,199€ with infliximab, 14,644€ with adalimumab, 17,270€ with ustekinumab, and 18,175€ with vedolizumab.

CONCLUSIONS: This real-world analysis in CD biologic-treated patients showed heterogeneity on persistence, being higher in ustekinumab-treated group. Results should be interpreted considering study limitations, such as its observational methodology, small sample size of some subgroups, persistence rate evaluation based on grace-period approach since dosage schedule of some drugs could have contributed to the persistence rates observed. Patients’ management was associated with quite comparable healthcare direct-costs, mainly derived from drug-related costs.