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维得利珠单抗在老年炎症性肠病患者中有效且安全:一项国际性、多中心、回顾性队列研究。

Vedolizumab is effective and safe in elderly inflammatory bowel disease patients: a binational, multicenter, retrospective cohort study.

机构信息

Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center, Tel-Aviv, Israel.

The Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK.

出版信息

United European Gastroenterol J. 2020 Nov;8(9):1076-1085. doi: 10.1177/2050640620951400. Epub 2020 Aug 17.

Abstract

BACKGROUND

Immune modulating therapies are associated with an increased risk of infections and malignancies. This is of particular concern in elderly inflammatory bowel disease patients. This study aims to compare the safety and efficacy of vedolizumab between young and elderly inflammatory bowel disease patients.

METHODS

A binational, multicentre, retrospective, cohort study was performed from 2015 to 2019. Patients who underwent treatment with vedolizumab and were followed for at least 14 weeks were studied. They were divided according to age into groups: 40 years or less or 60 years or older. Clinical and endoscopic responses at weeks 14 and 52 and infection development were compared between young and elderly inflammatory bowel disease patient groups.

RESULTS

There were 144 patients (82 Crohn's disease and 62 ulcerative colitis) in the elderly cohort and 140 patients (83 Crohn's disease and 57 ulcerative colitis) in the young cohort. The average age was 70.2 ± 7.3 years and 29.6 ± 5.7 years, respectively. Clinical and endoscopic responses were comparable between the groups (week 52 remission of Crohn's disease: 40% vs. 35%,  = 0.7; week 52 remission of ulcerative colitis: 48% vs. 51%,  = 0.84). Previous anti-tumour necrosis factor biological therapy was independently associated with poor clinical remission rates at week 52 (Crohn's disease: odds ratio 0.23, 95% confidence interval 0.06-0.79;  = 0.02 and ulcerative colitis: odds ratio 0.10 95% confidence interval 0.01-0.74;  = 0.024). There were significantly more infections in the elderly cohort (2% vs. 12%,  = 0.002), none of which were fatal.

CONCLUSIONS

Vedolizumab is equally effective in elderly and young inflammatory bowel disease patients. The findings of this study demonstrate an increased risk of infections among the elderly treated with vedolizumab, which may be related to their age and underlying diseases.

摘要

背景

免疫调节疗法与感染和恶性肿瘤的风险增加有关。这在老年炎症性肠病患者中尤为重要。本研究旨在比较年轻和老年炎症性肠病患者使用维得利珠单抗的安全性和疗效。

方法

本研究为 2015 年至 2019 年进行的一项双边、多中心、回顾性队列研究。研究对象为接受维得利珠单抗治疗且至少随访 14 周的患者。根据年龄将其分为两组:40 岁或以下或 60 岁或以上。比较年轻和老年炎症性肠病患者组在第 14 周和第 52 周的临床和内镜反应以及感染的发生情况。

结果

老年组有 144 例患者(82 例克罗恩病和 62 例溃疡性结肠炎),年轻组有 140 例患者(83 例克罗恩病和 57 例溃疡性结肠炎)。平均年龄分别为 70.2±7.3 岁和 29.6±5.7 岁。两组之间的临床和内镜反应相似(第 52 周克罗恩病缓解率:40% vs. 35%,  = 0.7;第 52 周溃疡性结肠炎缓解率:48% vs. 51%,  = 0.84)。先前使用抗肿瘤坏死因子生物治疗与第 52 周临床缓解率差独立相关(克罗恩病:比值比 0.23,95%置信区间 0.06-0.79;  = 0.02;溃疡性结肠炎:比值比 0.10,95%置信区间 0.01-0.74;  = 0.024)。老年组感染明显更多(2% vs. 12%,  = 0.002),但无致命感染。

结论

维得利珠单抗在老年和年轻炎症性肠病患者中同样有效。本研究结果表明,接受维得利珠单抗治疗的老年患者感染风险增加,这可能与他们的年龄和基础疾病有关。

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