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系统评价与荟萃分析:乌司奴单抗或维得利珠单抗治疗抗肿瘤坏死因子治疗应答不佳的克罗恩病患者的有效性。

Systematic review with meta-analysis: the effectiveness of either ustekinumab or vedolizumab in patients with Crohn's disease refractory to anti-tumour necrosis factor.

机构信息

Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Université Paris-Saclay, Le Kremlin Bicêtre, France.

出版信息

Aliment Pharmacol Ther. 2022 Feb;55(4):380-388. doi: 10.1111/apt.16714. Epub 2021 Dec 1.

Abstract

BACKGROUND

Ustekinumab and vedolizumab are commonly used after anti-tumour necrosis factor (TNF) failure in patients with Crohn's disease (CD). No randomised controlled trial has compared these drugs.

AIMS

To compare the effectiveness of ustekinumab and vedolizumab in CD patients refractory to anti-TNF.

METHODS

From PubMed, EMBASE and the Cochrane Library, through March 27, 2021, we identified studies that compared ustekinumab and vedolizumab in patients with CD refractory to anti-TNF. The main outcomes were clinical remission and steroid-free clinical remission at weeks 14 and 52. Secondary outcomes were biological remission and treatment persistence. We computed pooled odds ratios (OR) and 95% confidence intervals (CI) using random effects meta-analysis.

RESULTS

We identified 1513 reports. Among them, 38 studies were assessed for eligibility and five studies were included. All studies included were of high quality: four were retrospective and one was prospective. Among 1026 patients, 659 received ustekinumab and 367 received vedolizumab. At week 14, clinical remission (OR 1.36; 95%CI: 0.74-2.47; I  = 50%), steroid-free clinical remission (OR 1.24; 95%CI: 0.79-1.92; I  = 52%) and biological remission (OR 0.80; 95%CI: 0.50-1.28; I  = 0%) rates were similar between the two treatments. At week 52, ustekinumab was associated with higher rates of clinical remission (OR 1.87; 95% CI: 1.18-2.98; I  = 0%), steroid-free clinical remission (OR 1.56; 95% CI: 1.23-1.97; I  = 0%), biological remission (OR 1.86; 95% CI: 1.03-3.37; I  = 29%) and treatment persistence (OR 2.37; 95% CI: 1.56-3.62; I  = 0%).

CONCLUSION

In patients with CD refractory to anti-TNF, ustekinumab and vedolizumab are similarly effective in induction, but as maintenance treatment, ustekinumab appears to be more effective than vedolizumab.

摘要

背景

乌司奴单抗和维得利珠单抗常用于治疗对肿瘤坏死因子(TNF)治疗抵抗的克罗恩病(CD)患者。目前尚无随机对照试验比较这两种药物。

目的

比较乌司奴单抗和维得利珠单抗在 CD 患者中的疗效,这些患者对 TNF 拮抗剂治疗抵抗。

方法

我们从 PubMed、EMBASE 和 Cochrane 图书馆检索了截至 2021 年 3 月 27 日发表的比较乌司奴单抗和维得利珠单抗在对 TNF 拮抗剂治疗抵抗的 CD 患者中的疗效的研究。主要结局是治疗第 14 周和第 52 周的临床缓解和无激素临床缓解。次要结局是生物缓解和治疗持续时间。我们采用随机效应荟萃分析计算合并优势比(OR)和 95%置信区间(CI)。

结果

我们共检索到 1513 篇文献,其中 38 项研究符合纳入标准,最终纳入 5 项研究。所有纳入的研究均为高质量研究:4 项为回顾性研究,1 项为前瞻性研究。在 1026 名患者中,659 名接受了乌司奴单抗治疗,367 名接受了维得利珠单抗治疗。在第 14 周时,两种治疗方法的临床缓解率(OR 1.36;95%CI:0.74-2.47;I²=50%)、无激素临床缓解率(OR 1.24;95%CI:0.79-1.92;I²=52%)和生物缓解率(OR 0.80;95%CI:0.50-1.28;I²=0%)相似。在第 52 周时,乌司奴单抗治疗的临床缓解率(OR 1.87;95%CI:1.18-2.98;I²=0%)、无激素临床缓解率(OR 1.56;95%CI:1.23-1.97;I²=0%)、生物缓解率(OR 1.86;95%CI:1.03-3.37;I²=29%)和治疗持续时间(OR 2.37;95%CI:1.56-3.62;I²=0%)均更高。

结论

在对 TNF 拮抗剂治疗抵抗的 CD 患者中,乌司奴单抗和维得利珠单抗在诱导缓解方面同样有效,但作为维持治疗,乌司奴单抗似乎比维得利珠单抗更有效。

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