维多珠单抗-类固醇联合疗法可改善溃疡性结肠炎患者的长期预后。

Vedolizumab-steroid combination therapy improves long-term prognosis in patients with ulcerative colitis.

作者信息

Yamada Yosuke, Ishida Natsuki, Takebe Tomohiro, Takahashi Kenichi, Asai Yusuke, Tamura Satoshi, Matsuura Tomoharu, Takano Ryosuke, Matsuura Ai, Yamade Mihoko, Iwaizumi Moriya, Hamaya Yasushi, Yamada Takanori, Osawa Satoshi, Yoshizawa Yashiro, Hosoda Yoshisuke, Ota Yuji, Hanai Hiroyuki, Sugimoto Ken

机构信息

Department of Gastroenterology, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan.

First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.

出版信息

BMC Gastroenterol. 2025 Apr 30;25(1):323. doi: 10.1186/s12876-025-03913-z.

DOI:10.1186/s12876-025-03913-z

PMID:40307703

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12042623/

Abstract

BACKGROUND

In real-world clinical settings, the clinical efficacy of vedolizumab (VDZ) in patients with ulcerative colitis (UC) remains unclear. In this study, we aimed to evaluate the efficacy of prednisolone (PSL)-VDZ combination therapy in patients with UC.

METHODS

Changes in the clinical activity index (CAI), blood test results, and the factors affecting VDZ rate and continuity were investigated. Patients who received at least 20 mg PSL within 1 week of VDZ induction were included in the VDZ + rapid PSL induction (VDZ + rPSL) group, and the remaining were assigned to the non-VDZ + rPSL group. Failure and non-failure in both groups were compared.

RESULTS

We conducted a comparative analysis of 38 patients with UC treated with VDZ (VDZ + rPSL, n = 14; non-VDZ + rPSL, n = 24). The CAI in both groups improved significantly from week 2 to 24 compared with the pretreatment values (P < 0.01). Clinical remission and response at week 8 were significantly higher in the VDZ + rPSL group than in the non-VDZ + rPSL group (85.7% vs. 37.5%, P < 0.01 and 85.7% vs. 41.7%, P = 0.02, respectively). Kaplan-Meier analysis showed a significant difference in the failure-free rate between the two groups (log-rank test, P = 0.02). In the VDZ + rPSL group, only C-reactive protein (CRP) levels significantly improved in non-failure at week 2 (P=0.04).

CONCLUSIONS

VDZ + rPSL induction therapy is beneficial for UC treatment. CRP levels 2 weeks after VDZ induction may influence the continuation rate in the VDZ + rPSL group.

摘要

背景

在现实世界的临床环境中，维多珠单抗（VDZ）对溃疡性结肠炎（UC）患者的临床疗效仍不明确。在本研究中，我们旨在评估泼尼松龙（PSL）-VDZ联合治疗对UC患者的疗效。

方法

研究临床活动指数（CAI）、血液检查结果的变化以及影响VDZ使用率和持续率的因素。在VDZ诱导治疗1周内接受至少20mg PSL治疗的患者被纳入VDZ+快速PSL诱导（VDZ+rPSL）组，其余患者被分配到非VDZ+rPSL组。比较两组的治疗失败和未失败情况。

结果

我们对38例接受VDZ治疗的UC患者进行了对比分析（VDZ+rPSL组，n=14；非VDZ+rPSL组，n=24）。与治疗前值相比，两组的CAI在第2周至24周均有显著改善（P<0.01）。VDZ+rPSL组第8周的临床缓解率和缓解反应率显著高于非VDZ+rPSL组（分别为85.7%对37.5%，P<0.01；85.7%对41.7%，P=0.02）。Kaplan-Meier分析显示两组的无失败率有显著差异（对数秩检验，P=0.02）。在VDZ+rPSL组，仅第2周未失败患者的C反应蛋白（CRP）水平显著改善（P=0.04）。