IBD Center, Gastroenterology, Swedish Medical Center, Seattle, WA, USA.
HEOR/Value & Evidence Generation, Medical Affairs, Quantitative Clinical Pharmacology, IGI & Neuro and Vaccine, Takeda Development Center Americas, Inc, Lexington, MA, USA.
Curr Med Res Opin. 2024 May;40(5):877-885. doi: 10.1080/03007995.2024.2326585. Epub 2024 Apr 8.
To compare real-world treatment persistence, dose escalation, rates of opportunistic or serious infections, and healthcare costs in patients with Crohn's disease (CD) receiving vedolizumab (VDZ) vs ustekinumab (UST) in the United States.
A retrospective observational study in adults with CD initiated on VDZ or UST on/after 26 September 2016, was performed using the IBM Truven Health MarketScan databases (1 January 2009-30 September 2018). Rates of treatment persistence, dose escalation, opportunistic or serious infection-related encounters, and healthcare costs per patient per month (PPPM) were evaluated. Entropy balancing was used to balance patient characteristics between cohorts. Event rates were assessed using weighted Kaplan-Meier analyses and compared between cohorts using log-rank tests. Healthcare costs were compared between cohorts using weighted 2-part models.
589 VDZ and 599 UST patients were included (172 [29.2%] and 117 [19.5%] were bio-naïve, respectively). After weighting, baseline characteristics were comparable between cohorts. No significant difference in rates of treatment persistence (12-month: VDZ, 76.5%; UST, 82.1%; = .17), dose escalation (12-month: VDZ, 29.3%; UST, 32.7%; = .97), or opportunistic or serious infection-related encounters were observed between VDZ and UST. Total mean healthcare costs were significantly lower for patients treated with VDZ vs UST (mean cost difference = -$5051 PPPM; < .01). Findings were consistent in bio-naïve patients.
In this real-world study, similar treatment persistence, dose escalation, and rates of opportunistic or serious infections were observed with VDZ- and UST-treated patients with CD. However, VDZ was associated with a significantly lower cost outlay for healthcare systems.
比较美国接受维得利珠单抗（VDZ）和乌司奴单抗（UST）治疗的克罗恩病（CD）患者的真实世界治疗持续时间、剂量升级、机会性或严重感染发生率和医疗保健成本。
本研究为回顾性观察性研究，纳入 2016 年 9 月 26 日后开始接受 VDZ 或 UST 治疗的成年 CD 患者，数据来自 IBM Truven Health MarketScan 数据库（2009 年 1 月 1 日至 2018 年 9 月 30 日）。评估患者的治疗持续时间、剂量升级、机会性或严重感染相关就诊情况以及每位患者每月的医疗保健成本（PPPM）。采用熵平衡法对两组患者的患者特征进行平衡。采用加权 Kaplan-Meier 分析评估事件发生率，并采用对数秩检验比较两组之间的差异。采用加权两部分模型比较两组的医疗保健成本。
纳入 589 例 VDZ 患者和 599 例 UST 患者（分别有 172 例[29.2%]和 117 例[19.5%]为生物初治患者）。经加权处理后，两组患者的基线特征具有可比性。两组患者的治疗持续时间（12 个月：VDZ 组为 76.5%，UST 组为 82.1%； = .17）、剂量升级（12 个月：VDZ 组为 29.3%，UST 组为 32.7%； = .97）或机会性或严重感染相关就诊率均无显著差异。与 UST 相比，接受 VDZ 治疗的患者的总平均医疗保健成本显著降低（平均成本差异=-$5051 PPPM； < .01）。在生物初治患者中也观察到了类似的结果。
在这项真实世界研究中，接受 VDZ 和 UST 治疗的 CD 患者的治疗持续时间、剂量升级和机会性或严重感染发生率相似。然而，VDZ 与医疗保健系统的成本支出显著降低相关。
