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老年炎症性肠病患者肿瘤坏死因子 α 拮抗剂与维得利珠单抗的比较安全性和有效性:一项多中心研究。

Comparative safety and effectiveness of tumor necrosis factor α antagonists and vedolizumab in elderly IBD patients: a multicentre study.

机构信息

Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts.

Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, New York.

出版信息

Aliment Pharmacol Ther. 2019 Apr;49(7):873-879. doi: 10.1111/apt.15177. Epub 2019 Feb 17.

Abstract

BACKGROUND

The older patient group with inflammatory bowel diseases (IBD) is particularly vulnerable to consequences of disease and therapy-related side effects but little is known about the best treatment options in this population.

AIM

To compare safety and efficacy of tumor necrosis factor α antagonist (anti-TNF) or vedolizumab (VDZ) in patients with IBD >60 years of age.

METHODS

This retrospective study included patients with Crohn's disease (CD) or ulcerative colitis (UC) initiating anti-TNF or VDZ therapy ≥60 years of age at three study sites. We examined occurrence of infection or malignancy within 1 year after therapy as our primary outcome. Our efficacy outcomes included clinical remission at 3, 6 and 12 months. Multivariable logistic regression models adjusting for relevant confounders estimated odds ratios (OR) and 95% confidence intervals.

RESULTS

The study included 131 anti-TNF and 103 VDZ initiated patients (age range 60-88 years). Approximately half had CD. At 1 year, there were no significant differences in safety profile between the two therapeutic classes. Infections were observed in 20% of anti-TNF-treated and 17% of VDZ-treated patients (P = 0.54). Pneumonia was the most common infection in both groups. While more anti-TNF-treated CD patients were in remission at 3 months compared to VDZ (OR 2.82, 95% CI 1.18-6.76), this difference was not maintained at 6 and 12 months suggesting similar efficacy of both classes.

CONCLUSIONS

Both anti-TNF and VDZ therapy were similarly effective and safe in elderly IBD patients.

摘要

背景

炎症性肠病(IBD)的老年患者群体特别容易受到疾病和治疗相关副作用的影响,但对于该人群的最佳治疗选择知之甚少。

目的

比较肿瘤坏死因子 α 拮抗剂(抗 TNF)或 vedolizumab(VDZ)在年龄>60 岁的 IBD 患者中的安全性和疗效。

方法

这项回顾性研究纳入了在三个研究地点接受抗 TNF 或 VDZ 治疗≥60 岁的克罗恩病(CD)或溃疡性结肠炎(UC)患者。我们将治疗后 1 年内发生感染或恶性肿瘤作为主要观察终点。我们的疗效终点包括治疗后 3、6 和 12 个月的临床缓解。使用多变量逻辑回归模型调整相关混杂因素后,估计比值比(OR)及其 95%置信区间。

结果

研究纳入了 131 例接受抗 TNF 和 103 例接受 VDZ 治疗的患者(年龄范围为 60-88 岁)。大约一半患者患有 CD。在 1 年时,两种治疗方法的安全性特征无显著差异。抗 TNF 治疗组中 20%的患者和 VDZ 治疗组中 17%的患者发生感染(P=0.54)。两组中最常见的感染是肺炎。虽然在治疗 3 个月时,接受抗 TNF 治疗的 CD 患者缓解率高于 VDZ(OR 2.82,95%CI 1.18-6.76),但这种差异在 6 个月和 12 个月时并未维持,提示两种药物的疗效相当。

结论

在老年 IBD 患者中,抗 TNF 和 VDZ 治疗均具有相似的疗效和安全性。

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