生物制剂初治克罗恩病患者使用维得利珠单抗和乌司奴单抗的临床决策支持工具的特异性。

Specificity of clinical decision support tools for vedolizumab and ustekinumab in biologically naïve patients with Crohn's disease.

机构信息

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Biomedical Statistics Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea.

出版信息

Scand J Gastroenterol. 2022 Apr;57(4):446-448. doi: 10.1080/00365521.2021.2020332. Epub 2021 Dec 30.

DOI:10.1080/00365521.2021.2020332

PMID:34967701

Abstract

BACKGROUND AND AIMS

Clinical decision support tools (CDST) were developed to predict drug response to various biological treatments for Crohn's disease (CD). This study investigated whether CDSTs for vedolizumab (V-CDST) and ustekinumab (U-CDST) can be used as prognostic or drug-specific markers to predict response.

METHODS

A hypothetical scenario involving 872 patients with CD who were exposed to the first biological therapy at Samsung Medical Center between 1995 and 2020 is presented. V-CDST & U-CDST were calculated based on clinical and laboratory data immediately before the first biologic was initiated. The Cumulative Link Mixed Model (CLMM) test, weighted Kappa and plot, and Spearman's correlation was used to determine the degree of agreement and difference between the two tools.

RESULTS

25% of all patients diagnosed with biologically naïve CD were categorized into different probability groups using V-CDST and U-CDST. The difference between the two tools was significantly based on a two-sample paired ordinal test with Cumulative Link Mixed Model (CLMM) (-value < .001). Concordance between the two tools with a total of 654 subjects (75% of all patients) showed a similar probability (weighted Kappa: 0.47, 95% CI: 0.41-0.52).

CONCLUSIONS

V-CDST and U-CDST are useful in selecting vedolizumab or ustekinumab in 25% of biologically naïve CD patients in our hypothetical scenario.

摘要

背景与目的

临床决策支持工具（CDST）旨在预测各种生物治疗克罗恩病（CD）的药物反应。本研究旨在探讨针对维得利珠单抗（V-CDST）和乌司奴单抗（U-CDST）的 CDST 是否可用作预测应答的预后或药物特异性标志物。

方法

提出了一个涉及 1995 年至 2020 年期间在三星医疗中心接受首次生物治疗的 872 例 CD 患者的假设情况。根据首次使用生物制剂前的临床和实验室数据计算 V-CDST 和 U-CDST。采用累积链接混合模型（CLMM）检验、加权 Kappa 和图以及 Spearman 相关系数来确定两种工具之间的一致性和差异程度。

结果

根据 V-CDST 和 U-CDST，所有新诊断为生物初治 CD 的患者中有 25%被分为不同的概率组。两种工具之间的差异具有统计学意义，基于两样本配对有序检验的累积链接混合模型（CLMM）（-值<0.001）。654 例患者（所有患者的 75%）的两种工具之间的一致性显示出相似的概率（加权 Kappa：0.47，95%置信区间：0.41-0.52）。