托法替尼治疗的溃疡性结肠炎患者基线心血管风险的主要不良心血管事件:来自OCTAVE临床项目的数据

IF 8.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Journal of Crohns & Colitis Pub Date : 2023-11-24 DOI:10.1093/ecco-jcc/jjad104
Stefan Schreiber, David T Rubin, Siew C Ng, Laurent Peyrin-Biroulet, Silvio Danese, Irene Modesto, Xiang Guo, Chinyu Su, Kenneth K Kwok, Hyejin Jo, Yan Chen, Arne Yndestad, Walter Reinisch, Marla C Dubinsky
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引用次数: 1

摘要

背景和目的:炎症性肠病患者发生动脉粥样硬化性心血管疾病(ASCVD)的风险增加。托法替尼是一种用于治疗溃疡性结肠炎的口服Janus激酶抑制剂[UC]。我们报告了UC OCTAVE项目中的主要不良CV事件(MACE),并按基线CV风险分层。方法:通过基线[首次托法替尼暴露]CV风险概况、既往ASCVD或10年ASCVD风险分类[低、临界、中、高]分析MACE发生率。结果:1157例患者[2814.4患者-年]暴露;≤7.8年托法替尼治疗],4%有ASCVD病史,83%没有ASCVD病史,10年基线ASCVD风险低。8例(0.7%)患者发生MACE;1例既往有ASCVD。发病率[有事件的独特患者/100患者-年暴露;既往ASCVD患者MACE的95%置信区间为:0.95 [0.02-5.27];无ASCVD、基线10年ASCVD高、中、临界和低风险的患者分别为1.81[0.05-10.07]、1.54[0.42-3.95]、0.00[0.00-2.85]和0.09[0.01-0.32]。对于5/7的MACE患者,既往无ASCVD, MACE前的10年ASCVD风险评分比基线时高[>1%],主要是由于年龄的增加。结论:大多数在UC OCTAVE项目中接受托法替尼治疗的患者基线10年ASCVD风险较低。MACE在既往ASCVD和基线CV风险较高的患者中更为常见。该分析表明UC患者基线CV风险与MACE之间存在潜在关联,提示在临床实践中应单独评估CV风险。NCT01465763;NCT01458951;NCT01458574;NCT01470612。
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Major Adverse Cardiovascular Events by Baseline Cardiovascular Risk in Patients with Ulcerative Colitis Treated with Tofacitinib: Data from the OCTAVE Clinical Programme.

Background and aims: Patients with inflammatory bowel disease have increased risk of atherosclerotic cardiovascular [CV] disease [ASCVD]. Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis [UC]. We report major adverse CV events [MACE] in the UC OCTAVE programme, stratified by baseline CV risk.

Methods: Rates of MACE were analysed by baseline [first tofacitinib exposure] CV risk profile: prior ASCVD, or 10-year ASCVD risk categories [low, borderline, intermediate, high].

Results: Of 1157 patients [2814.4 patient-years of exposure; ≤7.8 years' tofacitinib treatment], 4% had prior ASCVD and 83% had no prior ASCVD and low-borderline baseline 10-year ASCVD risk. Eight [0.7%] patients developed MACE; one had prior ASCVD. Incidence rates [unique patients with events/100 patient-years of exposure; 95% confidence intervals] for MACE were: 0.95 [0.02-5.27] in patients with prior ASCVD; and 1.81 [0.05-10.07], 1.54 [0.42-3.95], 0.00 [0.00-2.85], and 0.09 [0.01-0.32] in patients without prior ASCVD and with high, intermediate, -borderline, and low baseline 10-year ASCVD risk, respectively. For the 5/7 patients with MACE and without prior ASCVD, 10-year ASCVD risk scores were numerically higher [>1%] prior to MACE versus at baseline, primarily due to increasing age.

Conclusions: Most patients receiving tofacitinib in the UC OCTAVE programme had low baseline 10-year ASCVD risk. MACE were more frequent in patients with prior ASCVD and higher baseline CV risk. This analysis demonstrates potential associations between baseline CV risk and MACE in patients with UC, suggesting CV risk should be assessed individually in clinical practice.

Clinicaltrials.gov: NCT00787202; NCT01465763; NCT01458951; NCT01458574; NCT01470612.

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来源期刊
Journal of Crohns & Colitis
Journal of Crohns & Colitis 医学-胃肠肝病学
CiteScore
15.50
自引率
7.50%
发文量
1048
审稿时长
1 months
期刊介绍: Journal of Crohns and Colitis is concerned with the dissemination of knowledge on clinical, basic science and innovative methods related to inflammatory bowel diseases. The journal publishes original articles, review papers, editorials, leading articles, viewpoints, case reports, innovative methods and letters to the editor.
期刊最新文献
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