Optum, Eden Prairie, MN, USA.
Takeda Pharmaceuticals U.S.A., Inc, Lexington, MA, USA.
BMC Gastroenterol. 2023 Mar 25;23(1):87. doi: 10.1186/s12876-023-02723-5.
Crohn's disease (CD) is a chronic inflammatory bowel disease characterized by relapsing and remitting inflammation that leads to progressive bowel damage. Despite advances in medical treatment for CD, many patients require surgical intervention. Most studies of surgery rates are from patients treated with anti-tumor necrosis factor alpha (anti-TNFα) treatments, with comparatively little data on the surgery rates of patients treated with vedolizumab and ustekinumab. SOJOURN aimed to estimate the hazard rate and incidence of the first CD-related surgery following initiation of treatment with vedolizumab or ustekinumab in biologic-naïve patients with CD.
SOJOURN was a retrospective, observational cohort study examining administrative claims data from the Optum® Research Database between July 1, 2017 and March 31, 2020. Included participants were adults with a diagnosis of CD and a claim for vedolizumab or ustekinumab (defined as the index treatment) between January 1, 2018 and December 31, 2019, with no claims for a biologic in the 6 months before initiation of this treatment. The variable follow-up started on the day after the index date and continued until whichever came first of discontinuation of the index treatment, surgery event, switching of the index treatment, initiation of combination biologic treatment, disenrollment, or March 31, 2020. The time to the first CD-related surgery on biologic treatment was estimated by Kaplan-Meier analysis. The hazard ratio and incidence rate ratio of CD-related surgery for each treatment cohort was compared using a Cox proportional hazards model and a Poisson regression model, respectively.
Of the 1,122 included patients, 578 received vedolizumab and 544 received ustekinumab. After 1 year of the variable follow-up, 7.7% of patients receiving vedolizumab and 11.6% of patients receiving ustekinumab had undergone a CD-related surgery. Vedolizumab was associated with a 34.2% lower hazard rate of surgery (hazard ratio 0.658, 95% confidence interval [CI] 0.436-0.994, p = 0.047) and a 34.5% lower incidence of surgery (rate ratio 0.655, 95% CI 0.434-0.988, p = 0.044) than ustekinumab.
This real-world analysis of biologic-naïve patients with CD suggests that vedolizumab is associated with greater effectiveness in reducing the rate of CD-related surgery than ustekinumab.
克罗恩病（CD）是一种慢性炎症性肠病，其特征为反复发作和缓解的炎症，导致进行性肠道损伤。尽管 CD 的医学治疗取得了进展，但许多患者仍需要手术干预。大多数关于手术率的研究都来自接受抗肿瘤坏死因子-α（anti-TNFα）治疗的患者，而接受 vedolizumab 和 ustekinumab 治疗的患者的数据相对较少。SOJOURN 旨在评估生物初治 CD 患者接受 vedolizumab 或 ustekinumab 治疗后首次与 CD 相关的手术的风险率和发生率。
SOJOURN 是一项回顾性、观察性队列研究，对 2017 年 7 月 1 日至 2020 年 3 月 31 日期间 Optum®研究数据库中的行政索赔数据进行了检查。纳入的参与者为患有 CD 的成年人，在 2018 年 1 月 1 日至 2019 年 12 月 31 日期间有 vedolizumab 或 ustekinumab（定义为指数治疗）的索赔，但在开始这种治疗前的 6 个月内没有生物制剂的索赔。随访变量从指数日期后的第二天开始，持续到指数治疗停止、手术事件、指数治疗转换、联合生物制剂治疗开始、退出或 2020 年 3 月 31 日中的第一个事件发生。通过 Kaplan-Meier 分析估计生物治疗期间首次与 CD 相关的手术时间。使用 Cox 比例风险模型和泊松回归模型分别比较了每个治疗队列中与 CD 相关的手术的风险比和发病率比。
在 1122 名纳入的患者中，578 名接受了 vedolizumab 治疗，544 名接受了 ustekinumab 治疗。在变量随访 1 年后，7.7%接受 vedolizumab 治疗的患者和 11.6%接受 ustekinumab 治疗的患者接受了与 CD 相关的手术。与 ustekinumab 相比，vedolizumab 治疗与手术的风险率降低 34.2%（风险比 0.658，95%置信区间[CI] 0.436-0.994，p=0.047）和手术的发病率降低 34.5%（率比 0.655，95%CI 0.434-0.988，p=0.044）相关。
这项对生物初治 CD 患者的真实世界分析表明，与 ustekinumab 相比，vedolizumab 可更有效地降低与 CD 相关的手术率。
