乌帕替尼与托法替布治疗溃疡性结肠炎的疗效比较：一项美国倾向匹配队列研究。

Comparative Effectiveness of Upadacitinib and Tofacitinib in Ulcerative Colitis: A US Propensity-Matched Cohort Study.

作者信息

Kochhar Gursimran S, Khataniar Himsikhar, Jairath Vipul, Farraye Francis A, Desai Aakash

机构信息

Division of Gastroenterology, Hepatology and Nutrition, Allegheny Health Network, Pittsburgh, Pennsylvania, USA.

Department of Medicine, Allegheny Health Network, Pittsburgh, Pennsylvania, USA.

出版信息

Am J Gastroenterol. 2024 Dec 1;119(12):2471-2479. doi: 10.14309/ajg.0000000000002947. Epub 2024 Jul 5.

DOI:10.14309/ajg.0000000000002947

PMID:38976357

Abstract

INTRODUCTION

There are limited real-world data comparing the effectiveness of upadacitinib and tofacitinib in patients with ulcerative colitis (UC).

METHODS

We conducted a retrospective cohort study using TriNetX, a multi-institutional database, to compare the effectiveness of upadacitinib and tofacitinib in patients with UC. The primary aim was to assess the risk of a composite outcome of hospitalization requiring intravenous steroids and/or colectomy within 6 and 12 months. One-to-one propensity score matching was performed for demographics, comorbid conditions, mean hemoglobin, C-reactive protein, albumin, and calprotectin, and prior UC medications including recent oral or intravenous steroid use between the cohorts. Risk was expressed as adjusted odds ratio (aOR) with 95% confidence intervals (CI).

RESULTS

There were 526 patients in the upadacitinib cohort (mean age 40.4 ± 16.3, 44.8% female sex, 76.6% White race) and 1,149 patients in the tofacitinib cohort (mean age 42 ± 17.1, 41.9% female sex, 76% White race). After propensity score matching, there was no significant difference in the risk of the composite outcome of need for intravenous steroids and/or colectomy within 6 months (aOR 0.75, 95% CI 0.49-1.09). However, there was a lower risk of the composite outcome (aOR 0.63, 95% CI 0.44-0.89) in the upadacitinib cohort compared with the tofacitinib cohort within 12 months. There was no difference in the risk of intravenous steroid use (aOR 0.70, 95% CI 0.48-1.02) but lower risk of colectomy (aOR 0.46, 95% CI 0.27-0.79). In sensitivity analysis, there was also a lower risk of the composite outcome (aOR 0.64, 95% CI 0.44-0.94), including lower risk of intravenous steroid use (aOR 0.67, 95% CI 0.45-0.99) and colectomy (aOR 0.49, 95% CI 0.26-0.92) in the upadacitinib cohort compared with the tofacitinib cohort within 12 months.

DISCUSSION

This study utilizing real-world data showed that upadacitinib was associated with improved disease-specific outcomes at 12 months compared with tofacitinib in patients with UC.

摘要

引言

关于溃疡性结肠炎（UC）患者中乌帕替尼与托法替布疗效对比的真实世界数据有限。

方法

我们使用多机构数据库TriNetX进行了一项回顾性队列研究，以比较乌帕替尼与托法替布在UC患者中的疗效。主要目的是评估6个月和12个月内需要静脉使用类固醇和/或进行结肠切除术这一复合结局的风险。对各队列间的人口统计学特征、合并症、平均血红蛋白、C反应蛋白、白蛋白、钙卫蛋白以及既往UC用药情况（包括近期口服或静脉使用类固醇）进行1:1倾向评分匹配。风险以调整优势比（aOR）及95%置信区间（CI）表示。

结果

乌帕替尼队列中有526例患者（平均年龄40.4±16.3岁，女性占44.8%，白人占76.6%），托法替布队列中有1149例患者（平均年龄42±17.1岁，女性占41.9%，白人占76%）。倾向评分匹配后，6个月内需要静脉使用类固醇和/或进行结肠切除术这一复合结局的风险无显著差异（aOR 0.75，95%CI 0.49 - 1.09）。然而，在12个月内，与托法替布队列相比，乌帕替尼队列中该复合结局的风险更低（aOR 0.63，95%CI 0.44 - 0.89）。静脉使用类固醇的风险无差异（aOR 0.70，95%CI 0.48 - 1.02），但结肠切除术的风险更低（aOR 0.46，95%CI 0.27 - 0.79）。在敏感性分析中，12个月内与托法替布队列相比，乌帕替尼队列中该复合结局的风险也更低（aOR 0.64，95%CI 0.44 - 0.94），包括静脉使用类固醇的风险更低（aOR 0.67，95%CI 0.45 - 0.99）以及结肠切除术的风险更低（aOR 0.49，95%CI 0.26 - 0.92）。