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与抗TNF药物相比,优特克单抗在接受维多珠单抗治疗的炎症性肠病患者中具有更高的持久性:一项真实世界队列研究。

Superior persistence of ustekinumab compared to anti-TNF in vedolizumab-experienced inflammatory bowel diseases patients: a real-world cohort study.

作者信息

Chiu Horng-Yih, Kuo Chia-Jung, Lai Ming-Wei, Wu Ren-Chin, Chen Chien-Ming, Chiu Cheng-Tang, Pan Yu-Bin, Chiu Cheng-Hsun, Le Puo-Hsien

机构信息

School of Medicine, Chang Gung University, Taoyuan City, Taiwan.

Department of Gastroenterology and Hepatology, Linkou Branch, Chang Gung Memorial Hospital, 5, Fu-Hsin Street, Guei-Shan District, Taoyuan, 33305, Taiwan.

出版信息

BMC Gastroenterol. 2024 Dec 31;24(1):483. doi: 10.1186/s12876-024-03577-1.

Abstract

BACKGROUND/AIMS: The increasing use of biologic therapies for moderate to severe inflammatory bowel disease (IBD) highlights the importance of optimal treatment sequencing, particularly after vedolizumab (VDZ) exposure. Studies comparing the effectiveness of ustekinumab (UST) and antitumor necrosis factor (anti-TNF) agents post-VDZ are limited.

METHODS

This retrospective study analyzed VDZ-experienced IBD patients treated with UST or anti-TNF (adalimumab and infliximab) from May 2019 to January 2024. We conducted a comparative analysis of the 52-week treatment persistence between UST and anti-TNF therapies, while also identifying independent predictors that influence 52-week persistence.

RESULTS

The study included 110 participants, with 40 diagnosed with ulcerative colitis (UC) and 70 with Crohn's disease (CD). Demographics were comparable across treatment groups. The primary discontinuation reason for VDZ was secondary non-response. Kaplan-Meier analysis revealed that UST demonstrated superior 52-week persistence in overall IBD, CD and UC patients, compared to anti-TNF. Cox regression analysis also showed UST's superiority in overall IBD (HR: 0.15, 95% CI: 0.05-0.45, p < 0.001), CD (HR: 0.09, 95% CI: 0.01-0.68, p = 0.02), and UC (HR: 0.28, 95% CI: 0.08-0.996, p = 0.049). The independent predictors for 52-week treatment persistence are Crohn's disease (Odds Ratio: 7.151, 95% CI: 1.763-28.995, p = 0.006) and UST treatment (Odds Ratio: 7.912, 95% CI: 1.789-34.992, p = 0.006). Notably, UST required more frequent dosing adjustments than anti-TNF, although both treatments exhibited comparable safety profiles.

CONCLUSIONS

UST demonstrated superior 52-week treatment persistence in IBD patients previously treated with VDZ compared to anti-TNF agents, albeit with a need for more frequent dose adjustments.

摘要

背景/目的:生物疗法在中重度炎症性肠病(IBD)治疗中的应用日益增多,这凸显了优化治疗顺序的重要性,尤其是在接受维多珠单抗(VDZ)治疗之后。比较优特克单抗(UST)和抗肿瘤坏死因子(抗TNF)药物在VDZ治疗后的疗效的研究有限。

方法

这项回顾性研究分析了2019年5月至2024年1月期间接受UST或抗TNF(阿达木单抗和英夫利昔单抗)治疗的有VDZ治疗经历的IBD患者。我们对UST和抗TNF治疗之间的52周治疗持续率进行了比较分析,同时还确定了影响52周持续率的独立预测因素。

结果

该研究纳入了110名参与者,其中40例诊断为溃疡性结肠炎(UC),70例诊断为克罗恩病(CD)。各治疗组的人口统计学特征具有可比性。VDZ的主要停药原因是继发性无反应。Kaplan-Meier分析显示,与抗TNF相比,UST在总体IBD、CD和UC患者中表现出更好的52周持续率。Cox回归分析还显示UST在总体IBD(风险比:0.15,95%置信区间:0.05-0.45,p<0.001)、CD(风险比:0.09,95%置信区间:0.01-0.68,p=0.02)和UC(风险比:0.28,95%置信区间:0.08-0.996,p=0.049)方面具有优势。52周治疗持续率的独立预测因素是克罗恩病(优势比:7.151,95%置信区间:1.763-28.995,p=0.006)和UST治疗(优势比:7.912,95%置信区间:1.789-34.992,p=0.006)。值得注意的是,尽管两种治疗的安全性相当,但UST比抗TNF需要更频繁的剂量调整。

结论

与抗TNF药物相比,UST在先前接受VDZ治疗的IBD患者中表现出更好的52周治疗持续率,尽管需要更频繁的剂量调整。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3d6/11686934/edbafca42da3/12876_2024_3577_Fig1_HTML.jpg

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