研究动态
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乌司奴单抗和维多珠单抗在克罗恩病术后预防和挽救治疗中的疗效:真实世界数据。

Efficacy of Ustekinumab and Vedolizumab Among Postoperative Crohn's Disease Patients as Postoperative Prophylaxis and Rescue Therapy: Real-world Data.

发表日期:2024 Jul 02
作者: Furkan U Ertem, Claudia Ramos Rivers, Amir Ali Ghaffari, Andrew R Watson, Gong Tang, Marc Schwartz, Elyse Johnston, Arthur Barrie, Janet Harrison, Jeffrey M Dueker, Doug Hartman, David G Binion
来源: INFLAMMATORY BOWEL DISEASES

摘要:

几乎一半的克罗恩病 (CD) 患者一生中需要进行肠道手术。由于术后疾病复发的高风险以及既往抗肿瘤坏死因子(抗 TNF)失败率高,通常使用乌特克单抗(UST)和维多珠单抗(VDZ)等替代治疗方案。我们的目的是评估UST和VDZ在术后CD患者中作为术后预防和抢救治疗的疗效。本研究纳入了同意接受初次回盲部切除术并接受UST和VDZ治疗的CD患者。收集人口统计学、临床特征、医疗保健利用、内窥镜检查评分和手术结果。术后早期 CD 复发定义为前 2 年内 Rutgeerts 内镜评分≥i2。挽救治疗组定义为术后Rutgeerts内镜评分≥i2后接受UST或VDZ的患者。2009年至2019年,98名CD患者术后接受了UST或VDZ治疗。 UST 组和 VDZ 组的术后早期复发率分别为 5%(n =20 人中的 1/1)和 6%(15 人中的 1 人)。 UST 组的 2 名患者和 VDZ 组的 1 名患者在随访期间需要进行肠道手术,中位药物暴露分别为 51(95% 置信区间 [CI],29-61)和 30(95% CI,14-63)分别为几个月; 55% 和 69% 的患者 UST 和 VDZ 术后内镜 Rutgeerts 评分分别提高至少 1 分。在接受 UST 和 VDZ 作为挽救治疗的同时,随访期间,只有 40 名患者中的 3 名和 23 名患者中只有 1 名需要进行肠道手术。无论是作为预防还是挽救治疗,UST 和 VDZ 作为术后治疗都是有效的。© 作者 2024由牛津大学出版社代表克罗恩病出版。
Almost half of patients with Crohn's disease (CD) require bowel surgeries in their lifetime. Due to the high risk of postoperative disease recurrence and high rate of previous antitumor necrosis factor (anti-TNF) failure, often alternative therapy options such as ustekinumab (UST) and vedolizumab (VDZ) are used. We aimed to evaluate the efficacy of UST and VDZ among postoperative CD patients as postoperative prophylaxis and rescue therapy.Consented CD patients who underwent initial ileocecal resection and were treated with UST and VDZ were included in this study. Demographics, clinical characteristics, health care utilization, endoscopy scores, and surgery outcomes were collected. Postoperative early CD recurrence was defined as a Rutgeerts endoscopic score ≥i2 within the first 2 years. The rescue therapy group was defined as patients who received either UST or VDZ after having Rutgeerts endoscopic score ≥i2 postoperatively.During 2009 to 2019, 98 CD patients were treated with UST or VDZ postoperatively. Postoperative early recurrence rates were 5% (n = 1 out of 20) and 6% (1 out of 15) for the UST and VDZ groups, respectively. Two patients from the UST group and 1 patient from the VDZ group required bowel surgery during follow-up with median drug exposure of 51 (95% confidence interval [CI], 29-61) and 30 (95% CI, 14-63) months, respectively; 55% and 69% of patients had at least 1 point of improvement on postoperative endoscopic Rutgeerts score, respectively, for UST and VDZ. Only 3 out of 40 and 1 out of 23 patients required bowel surgery during follow-up while receiving UST and VDZ as rescue therapy.Both UST and VDZ were effective as postoperative therapies either as prophylaxis or rescue therapy.© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.