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抗 TNF 治疗与炎症性肠病退伍军人死亡率的相关性。

Association of Anti-Tumor Necrosis Factor Therapy With Mortality Among Veterans With Inflammatory Bowel Disease.

机构信息

Department of Internal Medicine, University of Michigan, Ann Arbor.

Veterans Affairs Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.

出版信息

JAMA Netw Open. 2021 Mar 1;4(3):e210313. doi: 10.1001/jamanetworkopen.2021.0313.

Abstract

IMPORTANCE

Inflammatory bowel disease (IBD) is commonly treated with corticosteroids and anti-tumor necrosis factor (TNF) drugs; however, medications have well-described adverse effects. Prior work suggests that anti-TNF therapy may reduce all-cause mortality compared with prolonged corticosteroid use among Medicare and Medicaid beneficiaries with IBD.

OBJECTIVE

To examine the association between use of anti-TNF or corticosteroids and all-cause mortality in a national cohort of veterans with IBD.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used a well-established Veteran's Health Administration cohort of 2997 patients with IBD treated with prolonged corticosteroids (≥3000-mg prednisone equivalent and/or ≥600 mg of budesonide within a 12-month period) and/or new anti-TNF therapy from January 1, 2006, to October 1, 2015. Data were analyzed between July 1, 2019, and December 31, 2020.

EXPOSURES

Use of corticosteroids or anti-TNF.

MAIN OUTCOMES AND MEASURES

The primary end point was all-cause mortality as defined by the Veterans Health Administration vital status file. Marginal structural modeling was used to compare associations between anti-TNF therapy or corticosteroid use and all-cause mortality.

RESULTS

A total of 2997 patients (2725 men [90.9%]; mean [SD] age, 50.0 [17.4] years) were included in the final analysis, 1734 (57.9%) with Crohn disease (CD) and 1263 (42.1%) with ulcerative colitis (UC). All-cause mortality was 8.5% (n = 256) over a mean (SD) of 3.9 (2.3) years' follow-up. At cohort entry, 1836 patients were new anti-TNF therapy users, and 1161 were prolonged corticosteroid users. Anti-TNF therapy use was associated with a lower likelihood of mortality for CD (odds ratio [OR], 0.54; 95% CI, 0.31-0.93) but not for UC (OR, 0.33; 95% CI, 0.10-1.10). In a sensitivity analysis adjusting prolonged corticosteroid users to include patients receiving corticosteroids within 90 to 270 days after initiation of anti-TNF therapy, the OR for UC was statistically significant, at 0.33 (95% CI, 0.13-0.84), and the OR for CD was 0.55 (95% CI, 0.33-0.92).

CONCLUSIONS AND RELEVANCE

This study suggests that anti-TNF therapy may be associated with reduced mortality compared with long-term corticosteroid use among veterans with CD, and potentially among those with UC.

摘要

重要性

炎症性肠病(IBD)通常采用皮质类固醇和抗肿瘤坏死因子(TNF)药物进行治疗;然而,这些药物具有明确的不良反应。先前的研究表明,与延长皮质类固醇的使用相比,抗 TNF 治疗可能会降低医疗保险和医疗补助受益人的全因死亡率患有 IBD。

目的

在患有 IBD 的全国退伍军人队列中,检查使用抗 TNF 或皮质类固醇与全因死亡率之间的关联。

设计、地点和参与者:这项队列研究使用了退伍军人事务部(VA)一项经过充分证实的队列,该队列纳入了 2997 名接受长期皮质类固醇治疗(≥3000mg 泼尼松等效物和/或 12 个月内≥600mg 布地奈德)和/或新的抗 TNF 治疗的 IBD 患者。数据于 2019 年 7 月 1 日至 2020 年 12 月 31 日之间进行分析。

暴露

皮质类固醇或抗 TNF 的使用。

主要结局和测量指标

主要终点是退伍军人事务部生命状态文件定义的全因死亡率。边缘结构模型用于比较抗 TNF 治疗或皮质类固醇使用与全因死亡率之间的关联。

结果

共纳入 2997 名患者(2725 名男性[90.9%];平均[SD]年龄,50.0[17.4]岁)进行最终分析,其中 1734 名(57.9%)患有克罗恩病(CD),1263 名(42.1%)患有溃疡性结肠炎(UC)。在平均(SD)3.9(2.3)年的随访中,共有 256 人(8.5%)发生全因死亡。在队列入组时,1836 名患者为新的抗 TNF 治疗使用者,1161 名患者为长期皮质类固醇使用者。抗 TNF 治疗与 CD 的死亡率降低相关(比值比[OR],0.54;95%置信区间,0.31-0.93),但与 UC 无关(OR,0.33;95%置信区间,0.10-1.10)。在调整长期皮质类固醇使用者以纳入在开始抗 TNF 治疗后 90 至 270 天内接受皮质类固醇治疗的患者的敏感性分析中,UC 的 OR 具有统计学意义,为 0.33(95%置信区间,0.13-0.84),而 CD 的 OR 为 0.55(95%置信区间,0.33-0.92)。

结论和相关性

本研究表明,与长期皮质类固醇治疗相比,抗 TNF 治疗可能与 CD 退伍军人的死亡率降低相关,并且可能与 UC 退伍军人的死亡率降低相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/febf/7921894/301eb16b5db3/jamanetwopen-e210313-g001.jpg

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