Comparison of clinical and endoscopic efficacy between vedolizumab and infliximab in bio-naïve patients with ulcerative colitis: a multicenter, real-world study.
IF 4.3 3区 材料科学Q1 ENGINEERING, ELECTRICAL & ELECTRONIC
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引用次数: 0
Abstract
Background: No head-to-head trial directly compares the effectiveness of vedolizumab (VDZ) and infliximab (IFX) in patients with ulcerative colitis (UC) who were naïve to biologic therapy.
Objectives: We aimed to compare the clinical and endoscopic effectiveness of VDZ and IFX in biologic-naïve patients with UC in real-world settings.
Design: It was a multicenter, observational, real-world cohort study conducted at five centers.
Methods: Patients diagnosed with UC and treated with either IFX or VDZ as their first-line biologic therapy were retrospectively enrolled. Steroid-free remission, clinical response, clinical remission, and endoscopic healing at week 14 and week 52 were compared between the two groups after propensity score weighting.
Results: A total of 199 patients (117 VDZ and 82 IFX) were included in the study. There were no significant differences in steroid-free remission (64.6% vs 56.1%, p = 0.224), clinical response (83.4% vs 73.4%, p = 0.086), or clinical remission (69.4% vs 60.1%, p = 0.174) at week 14. However, VDZ showed better results in steroid-free remission (67.5% vs 44.4%, p = 0.004), clinical response (69.7% vs 47.1%, p = 0.005), and clinical remission (67.5% vs 44.4%, p = 0.004) at week 52. In terms of endoscopic healing, VDZ was similar to IFX at week 14 (25.7% vs 17.4%, p = 0.185), but VDZ had a significantly higher rate at week 52 (29.5% vs 11.8%, p = 0.027). VDZ was found to be superior to IFX in therapeutic continuation (hazard ratio = 0.339, 95% CI: 0.187-0.614, p < 0.001). The rate of adverse events was similar between the two groups (6.8% vs 8.5%, p = 0.655).
Conclusion: VDZ demonstrated similar clinical and endoscopic effectiveness to IFX at week 14 in biologic-naïve patients with UC, but appeared to be superior at week 52. The safety outcomes were comparable between the groups.
背景:目前还没有头对头试验直接比较维多珠单抗(VDZ)和英夫利昔单抗(IFX)对接受过生物治疗的溃疡性结肠炎(UC)患者的疗效:我们旨在比较VDZ和IFX在现实世界中对生物制剂治疗无效的UC患者的临床和内镜疗效:这是一项多中心、观察性、真实世界队列研究,在五个中心进行:方法:回顾性纳入被诊断为UC并接受IFX或VDZ作为一线生物治疗的患者。经过倾向得分加权后,比较了两组患者在第14周和第52周的无类固醇缓解、临床反应、临床缓解和内镜愈合情况:研究共纳入199名患者(117名VDZ患者和82名IFX患者)。第14周时,无类固醇缓解率(64.6% vs 56.1%,P = 0.224)、临床反应率(83.4% vs 73.4%,P = 0.086)或临床缓解率(69.4% vs 60.1%,P = 0.174)均无明显差异。然而,在第52周时,VDZ在无类固醇缓解(67.5% vs 44.4%,p = 0.004)、临床反应(69.7% vs 47.1%,p = 0.005)和临床缓解(67.5% vs 44.4%,p = 0.004)方面显示出更好的效果。在内镜愈合方面,第14周时VDZ与IFX相似(25.7% vs 17.4%,p = 0.185),但第52周时VDZ的愈合率明显更高(29.5% vs 11.8%,p = 0.027)。VDZ在继续治疗方面优于IFX(危险比=0.339,95% CI:0.187-0.614,P=0.655):结论:在第14周时,VDZ对生物制剂无效的UC患者的临床和内镜疗效与IFX相似,但在第52周时似乎更胜一筹。两组的安全性结果相当。