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.
JAMA Netw Open. 2021 Mar 1;4(3):e210313. doi: 10.1001/jamanetworkopen.2021.0313.
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.
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.
Use of corticosteroids or anti-TNF.
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.
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).
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.
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。
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。
皮质类固醇或抗 TNF 的使用。
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。
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)。
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。