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生物制剂治疗克罗恩病患者的治疗模式、药物停药和医疗保健成本的回顾性分析。

A retrospective analysis of treatment patterns, drug discontinuation and healthcare costs in Crohn's disease patients treated with biologics.

机构信息

CliCon S.r.l., Società Benefit, Health, Economics & Outcomes Research, 40137 Bologna, Italy.

SC Gastroenterologia AO Ordine Mauriziano di Torino, 10128 Torino, Italy.

出版信息

Dig Liver Dis. 2023 Sep;55(9):1214-1220. doi: 10.1016/j.dld.2023.04.010. Epub 2023 Apr 24.

Abstract

BACKGROUND/AIMS: This real-world analysis evaluated the persistence and direct healthcare costs of Crohn's Disease (CD) patients treated with biologics in Italy.

METHODS

A retrospective analysis on administrative databases of Italian healthcare entities, covering 10.4 million residents, was performed. Adult CD patients under biologics between 2015 and 2020 were included and attributed to first/second treatment line based on absence/presence of biologic prescriptions 5-years before index-date (first biologic prescription).

RESULTS

Of 16,374 CD patients identified, 1,398 (8.5%) were biologic-treated: 1,256 (89.8%) in first line and 135 (9.7%) in second line. Kaplan-Meier curves estimated a higher persistence for ustekinumab-treated patients followed by vedolizumab, infliximab and adalimumab, in both lines. 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 significantly reduced risk of drug-discontinuation. First line total/average healthcare direct-costs were €13,637, €11,201, €17,104 and €18,340 in patients persistent on adalimumab, infliximab, ustekinumab and vedolizumab, respectively.

CONCLUSIONS

This real-world analysis showed differences in persistence over 12-months between biologic treatments, being higher in ustekinumab-treated group, followed by vedolizumab, infliximab and adalimumab. Patients' management was associated with comparable direct healthcare costs among treatment lines, mainly driven by drug-related expenses.

摘要

背景/目的:本真实世界分析评估了意大利接受生物制剂治疗的克罗恩病(CD)患者的持续性和直接医疗成本。

方法

对意大利医疗实体的行政数据库进行回顾性分析,涵盖 1040 万居民。纳入 2015 年至 2020 年期间接受生物制剂治疗的成年 CD 患者,并根据索引日期(首次生物制剂处方)前 5 年是否存在生物制剂处方将其分为一线/二线治疗。

结果

在确定的 16374 例 CD 患者中,有 1398 例(8.5%)接受了生物制剂治疗:一线治疗 1256 例(89.8%),二线治疗 135 例(9.7%)。Kaplan-Meier 曲线估计,在一线和二线治疗中,乌司奴单抗治疗的患者具有更高的持续性,其次是维得利珠单抗、英夫利昔单抗和阿达木单抗。考虑到基线变量和阿达木单抗作为参考,一线治疗中的英夫利昔单抗(HR:0.537)和一线(HR:0.057)和二线(HR:0.213)的乌司奴单抗与药物停药风险显著降低相关。一线持续治疗的总/平均直接医疗费用分别为:阿达木单抗、英夫利昔单抗、乌司奴单抗和维得利珠单抗的患者分别为 13637 欧元、11201 欧元、17104 欧元和 18340 欧元。

结论

本真实世界分析显示,12 个月内生物制剂治疗的持续性存在差异,乌司奴单抗治疗组较高,其次是维得利珠单抗、英夫利昔单抗和阿达木单抗。患者管理与治疗线之间的直接医疗成本相当,主要由药物相关费用驱动。

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