vedolizumab 与肿瘤坏死因子拮抗剂治疗炎症性肠病患者的严重感染风险。
Risk of Serious Infections With Vedolizumab Versus Tumor Necrosis Factor Antagonists in Patients With Inflammatory Bowel Disease.
机构信息
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Saint-Antoine, Department of Gastroenterology, Paris, France.
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
出版信息
Clin Gastroenterol Hepatol. 2022 Feb;20(2):314-324.e16. doi: 10.1016/j.cgh.2020.12.030. Epub 2020 Dec 30.
BACKGROUND & AIMS: The risk of serious infections associated with vedolizumab in patients with inflammatory bowel disease (IBD) is uncertain. We assessed the risk of serious infections associated with use of vedolizumab versus anti-TNF in patients with IBD, according to IBD subtype and previous exposure to anti-TNF.
METHODS
Based on two U.S. nationwide commercial insurance databases and the French nationwide health insurance database, anti-TNF naïve and experienced patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC) aged 18 years or older who initiated vedolizumab or an anti-TNF agent after 2010 were identified. Hazard ratios for serious infections comparing vedolizumab and anti-TNF were estimated in propensity score matched cohorts.
RESULTS
Among 8768 vedolizumab and 26,656 anti-TNF initiators included after 1:4 variable ratio propensity score matching, 893 serious infections occurred during 37,725 person-years of follow-up. The risk of serious infections was not different between vedolizumab and anti-TNF in the overall IBD cohort (HR, 0.95; 95% CI, 0·79-1.13), while the risk was decreased for vedolizumab users in patients with UC (HR, 0.68; 95% CI, 0.50-0.93), but not CD (HR, 1.10; 95% CI, 0.87-1.38). In patients with UC, vedolizumab was consistently associated with lower risk of serious infections after exclusion of gastrointestinal infections (HR, 0.59; 95% CI, 0.39-0.90).
CONCLUSIONS
While the risk of serious infections associated with vedolizumab was not different compared to anti-TNF in the overall group of patients with IBD, the risk varied according to IBD subtype, by decreasing in patients with UC, but not CD. These findings may help to clarify the optimal position of vedolizumab in the therapeutic management of IBD.
背景与目的
在炎症性肠病（IBD）患者中，与 vedolizumab 相关的严重感染风险尚不确定。我们评估了在 IBD 患者中，vedolizumab 与抗 TNF 治疗相比，与 IBD 亚型以及先前抗 TNF 暴露相关的严重感染风险。
方法
基于美国两个全国性商业保险数据库和法国全国性医疗保险数据库，纳入了 2010 年后开始接受 vedolizumab 或抗 TNF 药物治疗的年龄在 18 岁及以上的克罗恩病（CD）和溃疡性结肠炎（UC）初治患者。采用倾向评分匹配队列估计比较 vedolizumab 和抗 TNF 治疗的严重感染风险比（HR）。
结果
在经过 1:4 变量比例倾向评分匹配后，共纳入 8768 名 vedolizumab 初治患者和 26656 名抗 TNF 初治患者，在 37725 人年的随访期间共发生 893 例严重感染。在总体 IBD 患者中，vedolizumab 和抗 TNF 治疗的严重感染风险无差异（HR，0.95；95%CI，0.79-1.13），但在 UC 患者中 vedolizumab 治疗组风险降低（HR，0.68；95%CI，0.50-0.93），而在 CD 患者中则无差异（HR，1.10；95%CI，0.87-1.38）。在排除了胃肠道感染后，UC 患者中 vedolizumab 治疗与严重感染风险降低仍相关（HR，0.59；95%CI，0.39-0.90）。
结论
在总体 IBD 患者中，与抗 TNF 治疗相比，vedolizumab 治疗的严重感染风险无差异，但根据 IBD 亚型有所不同，UC 患者中风险降低，而 CD 患者中则无差异。这些发现可能有助于阐明 vedolizumab 在 IBD 治疗管理中的最佳定位。
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