Newman Kira L, Johnson Laura A, Stidham Ryan W, Higgins Peter D R
Division of Gastroenterology and Hepatology, Department of Medicine, University of Michigan, 3110 Taubman Center, SPC 5368, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5368, USA.
Division of Gastroenterology and Hepatology, Department of Medicine, University of Michigan, Ann Arbor, MI, USA.
Therap Adv Gastroenterol. 2023 Mar 3;16:17562848221148254. doi: 10.1177/17562848221148254. eCollection 2023.
Data on the performance of newer biologics in patients with fistulizing Crohn's disease (CD) are limited.
Our study's objective was to evaluate the response to ustekinumab (UST) and vedolizumab (VDZ) in patients with fistulizing CD.
Retrospective cohort.
We used natural language processing of electronic medical record data to identify a retrospective cohort of individuals with fistulizing CD at a single academic tertiary-care referral center and then performed a chart review. Individuals were eligible for inclusion if a fistula was present at the time of UST or VDZ initiation. Outcomes included medication discontinuation, surgical intervention, development of a new fistula, and fistula closure. Groups were compared with unadjusted analyses and competing risk analyses using multi-state survival models.
In all, 68 patients were included (48 UST and 20 VDZ). Most patients had one fistula (79%) and had prior anti-tumor necrosis factor-α treatment (98% in UST group, 80% in VDZ group, = 0.01). VDZ was significantly more likely to be discontinued than UST ( < 0.0001), most frequently due to inadequate clinical response. Those on UST had a longer median time to surgery for CD than those on VDZ ( = 0.008). In those without surgical fistula repair, 79% on UST and 100% on VDZ still had an active fistula at 1 year ( = 0.30).
In individuals with fistulizing CD, our data suggest that UST has better clinical utility than VDZ based on lower rates of discontinuation, though the sample size is small. These findings highlight the importance of further research on the treatment of perianal fistulizing Crohn's disease.
关于新型生物制剂在瘘管性克罗恩病(CD)患者中的疗效数据有限。
本研究的目的是评估乌司奴单抗(UST)和维多珠单抗(VDZ)在瘘管性CD患者中的反应。
回顾性队列研究。
我们使用电子病历数据的自然语言处理,在一家学术性三级医疗转诊中心确定了一个瘘管性CD患者的回顾性队列,然后进行了病历审查。如果在开始使用UST或VDZ时存在瘘管,则个体符合纳入标准。结局包括药物停用、手术干预、新瘘管的形成和瘘管闭合。使用多状态生存模型对各组进行未调整分析和竞争风险分析。
总共纳入了68例患者(48例使用UST,20例使用VDZ)。大多数患者有一个瘘管(79%),并且曾接受过抗肿瘤坏死因子-α治疗(UST组98%,VDZ组80%,P = 0.01)。VDZ比UST更有可能停药(P < 0.0001),最常见的原因是临床反应不足。使用UST的患者CD手术的中位时间比使用VDZ的患者长(P = 0.008)那些未进行手术瘘管修复的患者中,使用UST的患者在1年时仍有活动性瘘管的比例为79%,使用VDZ的患者为100%(P = 0.30)。
在瘘管性CD患者中,我们的数据表明,尽管样本量较小,但基于较低的停药率,UST比VDZ具有更好的临床效用。这些发现突出了进一步研究肛周瘘管性克罗恩病治疗的重要性。