抗 TNF、Vedolizumab 或 Ustekinumab 早期预防治疗后克罗恩病患者行回肠末端切除术的内镜术后复发：一项真实世界的多中心欧洲研究。

Endoscopic Postoperative Recurrence in Crohn's Disease After Curative Ileocecal Resection with Early Prophylaxis by Anti-TNF, Vedolizumab or Ustekinumab: A Real-World Multicentre European Study.

机构信息

Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.

Sackler Faculty of Medicine, Tel Aviv University, Israel.

出版信息

J Crohns Colitis. 2022 Dec 5;16(12):1882-1892. doi: 10.1093/ecco-jcc/jjac100.

DOI:10.1093/ecco-jcc/jjac100

PMID:35895074

Abstract

BACKGROUND

Endoscopic-post-operative-recurrence [ePOR] in Crohn's disease [CD] after ileocecal resection [ICR] is a major concern. We aimed to evaluate the effectiveness of early prophylaxis with biologics and to compare anti-tumour necrosis factor [anti-TNF] therapy to vedolizumab [VDZ] and ustekinumab [UST] in a real-world setting.

METHODS

A retrospective multicentre study of CD-adults after curative ICR on early prophylaxis was undertaken. ePOR was defined as a Rutgeerts score [RS] ≥ i2 or colonic-segmental-SES-CD ≥ 6. Multivariable logistic regression was used to evaluate risk factors, and inverse probability treatment weighting [IPTW] was applied to compare the effectiveness between agents.

RESULTS

The study included 297 patients (53.9% males, age at diagnosis 24 years [19-32], age at ICR 34 years [26-43], 18.5% smokers, 27.6% biologic-naïve, 65.7% anti-TNF experienced, 28.6% two or more biologics and 17.2% previous surgery). Overall, 224, 39 and 34 patients received anti-TNF, VDZ or UST, respectively. Patients treated with VDZ and UST were more biologic experienced with higher rates of previous surgery. ePOR rates within 1 year were 41.8%. ePOR rates by treatment groups were: anti-TNF 40.2%, VDZ 33% and UST 61.8%. Risk factors for ePOR at 1 year were: past-infliximab (adjusted odds ratio [adj.OR] = 1.73 [95% confidence interval, CI: 1.01-2.97]), past-adalimumab [adj.OR = 2.32 [95% CI: 1.35-4.01] and surgical aspects. After IPTW, the risk of ePOR within 1 year of VDZ vs anti-TNF or UST vs anti-TNF was comparable (OR = 0.55 [95% CI: 0.25-1.19], OR = 1.86 [95% CI: 0.79-4.38]), respectively.

CONCLUSION

Prevention of ePOR within 1 year after surgery was successful in ~60% of patients. Patients treated with VDZ or UST consisted of a more refractory group. After controlling for confounders, no differences in ePOR risk were seen between anti-TNF prophylaxis and other groups.

摘要

背景

回肠末端切除术后 [ICR] 后克罗恩病 [CD] 的内镜术后复发 [ePOR] 是一个主要关注点。我们旨在评估早期生物制剂预防的有效性，并在真实环境中比较抗肿瘤坏死因子 [anti-TNF] 治疗与 vedolizumab [VDZ] 和 ustekinumab [UST]。

方法

对接受根治性 ICR 的 CD 成人患者进行了一项回顾性多中心早期预防生物制剂的研究。ePOR 定义为 Rutgeerts 评分 [RS] ≥ i2 或结肠节段 SES-CD ≥ 6。使用多变量逻辑回归评估风险因素，并应用逆概率治疗加权 [IPTW] 比较药物之间的有效性。

结果

该研究纳入了 297 名患者（53.9%为男性，诊断时年龄 24 岁 [19-32]，ICR 时年龄 34 岁 [26-43]，18.5%吸烟，27.6%为生物制剂初治，65.7%接受过抗 TNF 治疗，28.6%使用过两种或以上生物制剂，17.2%有既往手术史）。总体而言，分别有 224、39 和 34 名患者接受了抗 TNF、VDZ 或 UST 治疗。接受 VDZ 和 UST 治疗的患者有更多的生物制剂治疗经验，既往手术率更高。1 年内 ePOR 发生率为 41.8%。各组 ePOR 发生率分别为：抗 TNF 组 40.2%，VDZ 组 33%，UST 组 61.8%。1 年内 ePOR 的风险因素包括：既往 infliximab（调整后优势比 [adj.OR] = 1.73 [95%置信区间，CI：1.01-2.97]）、既往 adalimumab [adj.OR = 2.32 [95%CI：1.35-4.01]）和手术方面。经 IPTW 后，1 年内 VDZ 与抗 TNF 或 UST 与抗 TNF 相比，ePOR 的风险相当（OR = 0.55 [95%CI：0.25-1.19]，OR = 1.86 [95%CI：0.79-4.38]）。