合并症而非患者年龄与 vedolizumab 和 ustekinumab 治疗的炎症性肠病患者安全性结局受损相关:一项前瞻性多中心队列研究。

Comorbidity, not patient age, is associated with impaired safety outcomes in vedolizumab- and ustekinumab-treated patients with inflammatory bowel disease-a prospective multicentre cohort study.

机构信息

Leiden, the Netherlands.

Nijmegen, the Netherlands.

出版信息

Aliment Pharmacol Ther. 2020 Oct;52(8):1366-1376. doi: 10.1111/apt.16073. Epub 2020 Sep 9.

Abstract

BACKGROUND

Few data are available on the effects of age and comorbidity on treatment outcomes of vedolizumab and ustekinumab in inflammatory bowel disease (IBD).

AIMS

To evaluate the association between age and comorbidity with safety and effectiveness outcomes of vedolizumab and ustekinumab in IBD.

METHODS

IBD patients initiating vedolizumab or ustekinumab in regular care were enrolled prospectively. Comorbidity prevalence was assessed using the Charlson Comorbidity Index (CCI). Association between age and CCI, both continuously assessed, with safety outcomes (any infection, hospitalisation, adverse events) during treatment, and effectiveness outcomes (clinical response and remission, corticosteroid-free remission, clinical remission combined with biochemical remission) after 52 weeks of treatment were evaluated. Multivariable logistic regression was used to adjust for confounders.

RESULTS

We included 203 vedolizumab- and 207 ustekinumab-treated IBD patients, mean age 42.2 (SD 16.0) and 41.6 (SD 14.4). Median treatment duration 54.0 (IQR 19.9-104.0) and 48.4 (IQR 24.4-55.1) weeks, median follow-up time 104.0 (IQR 103.1-104.0) and 52.0 weeks (IQR 49.3-100.4). On vedolizumab, CCI associated independently with any infection (OR 1.387, 95% CI 1.022-1.883, P = 0.036) and hospitalisation (OR 1.586, 95% CI 1.127-2.231, P = 0.008). On ustekinumab, CCI associated independently with hospitalisation (OR 1.621, 95% CI 1.034-2.541, P = 0.035). CCI was not associated with effectiveness, and age was not associated with any outcomes.

CONCLUSIONS

Comorbidity - but not age - is associated with an increased risk of hospitalisations on either treatment, and with any infection on vedolizumab. This underlines the importance of comorbidity assessment and safety monitoring of IBD patients.

摘要

背景

关于年龄和合并症对炎症性肠病(IBD)患者接受维得利珠单抗和乌司奴单抗治疗结局的影响,目前仅有少量数据。

目的

评估年龄和合并症与 IBD 患者接受维得利珠单抗和乌司奴单抗治疗的安全性和有效性结局之间的关联。

方法

前瞻性纳入在常规治疗中开始接受维得利珠单抗或乌司奴单抗治疗的 IBD 患者。使用 Charlson 合并症指数(CCI)评估合并症的患病率。连续评估年龄和 CCI 与治疗期间安全性结局(任何感染、住院、不良事件),以及治疗 52 周后的有效性结局(临床缓解和缓解、无皮质类固醇缓解、临床缓解伴生化缓解)之间的关联。采用多变量逻辑回归来调整混杂因素。

结果

共纳入 203 例接受维得利珠单抗治疗和 207 例接受乌司奴单抗治疗的 IBD 患者,平均年龄为 42.2(16.0)岁和 41.6(14.4)岁。中位治疗持续时间分别为 54.0(IQR 19.9-104.0)和 48.4(IQR 24.4-55.1)周,中位随访时间分别为 104.0(IQR 103.1-104.0)和 52.0(IQR 49.3-100.4)周。在维得利珠单抗组,CCI 与任何感染(OR 1.387,95%CI 1.022-1.883,P = 0.036)和住院(OR 1.586,95%CI 1.127-2.231,P = 0.008)独立相关。在乌司奴单抗组,CCI 与住院(OR 1.621,95%CI 1.034-2.541,P = 0.035)独立相关。CCI 与有效性无关,年龄与任何结局均无关。

结论

合并症(而非年龄)与两种治疗方案的住院风险增加相关,与维得利珠单抗的任何感染相关。这突显了评估 IBD 患者合并症和监测安全性的重要性。

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