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比较维得利珠单抗与阿达木单抗在克罗恩病中应用的倾向评分加权分析。

A propensity score weighted comparison of vedolizumab and adalimumab in Crohn's disease.

机构信息

Inflammatory Bowel Disease Unit, A.O.O.R. "Villa Sofia-Cervello", Palermo, Italy.

Inflammatory Bowel Disease Unit, A.O.U. Policlinico "G. Martino", Messina, Italy.

出版信息

J Gastroenterol Hepatol. 2021 Jan;36(1):105-111. doi: 10.1111/jgh.15107. Epub 2020 Jun 8.

Abstract

BACKGROUND AND AIM

There are no head-to-head randomized controlled trials between biologics in Crohn's disease (CD). We aimed to perform a multicenter, real-life comparison of the effectiveness of vedolizumab (VDZ) and adalimumab (ADA) in CD.

METHODS

Data of consecutive patients with CD treated with VDZ and ADA from January 2016 to April 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. The effectiveness was evaluated at 12, 52 weeks, and as failure-free survival at the end of follow up. Propensity score analysis was performed using the inverse probability of treatment weighting method.

RESULTS

Five hundred eighty-five treatments (VDZ: n = 277; ADA: n = 308) were included (median follow-up: 56.0 weeks). After 12 weeks, a clinical response was achieved in 64.3% patients treated with VDZ and in 83.1% patients treated with ADA (odds ratio [OR] 0.65, 95% confidence interval [CI] 0.38-1.10, P = 0.107), while at 52 weeks, a clinical response was observed in 54.0% patients treated with VDZ and in 69.1% patients treated with ADA (OR 0.77, 95% CI 0.45-1.31, P = 0.336). Cox survival analysis weighted for propensity score showed no significant difference in the probability of failure-free survival between the two drugs (hazard ratio = 1.20, 95% CI 0.83-1.74, P = 0.340). Post-treatment endoscopic response and mucosal healing rates were similar between the two groups (endoscopic response: 35.3% for VDZ and 25.5% for ADA, P = 0.15; mucosal healing: 31.8% for VDZ and 33.8% for ADA, P = 0.85).

CONCLUSIONS

In the first study comparing VDZ and ADA in CD via propensity score analysis, the drugs showed comparable effectiveness and a similar safety profile.

摘要

背景与目的

目前尚无克罗恩病(CD)生物制剂头对头随机对照试验。我们旨在进行一项多中心、真实世界的 CD 中维得利珠单抗(VDZ)和阿达木单抗(ADA)疗效比较。

方法

本研究从西西里炎症性肠病网络的队列中提取了 2016 年 1 月至 2019 年 4 月接受 VDZ 和 ADA 治疗的连续 CD 患者的数据。分别在第 12 周、第 52 周评估疗效,在随访结束时评估无失败生存。采用逆概率治疗加权法进行倾向评分分析。

结果

共纳入 585 例治疗(VDZ:n=277;ADA:n=308)(中位随访时间:56.0 周)。第 12 周时,VDZ 组和 ADA 组分别有 64.3%和 83.1%的患者达到临床缓解(优势比[OR]0.65,95%置信区间[CI]0.38-1.10,P=0.107),第 52 周时,VDZ 组和 ADA 组分别有 54.0%和 69.1%的患者达到临床缓解(OR 0.77,95%CI 0.45-1.31,P=0.336)。经倾向评分加权的 Cox 生存分析显示,两种药物无失败生存的概率无显著差异(风险比=1.20,95%CI 0.83-1.74,P=0.340)。两组治疗后的内镜缓解率和黏膜愈合率相似(内镜缓解:VDZ 组为 35.3%,ADA 组为 25.5%,P=0.15;黏膜愈合:VDZ 组为 31.8%,ADA 组为 33.8%,P=0.85)。

结论

本研究通过倾向评分分析比较了 VDZ 和 ADA 在 CD 中的疗效,结果显示两种药物疗效相当,安全性相似。

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