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老年炎症性肠病患者抗 TNF 治疗的停药率增加。

Increased Discontinuation Rates of Anti-TNF Therapy in Elderly Inflammatory Bowel Disease Patients.

机构信息

Inflammatory Bowel Disease Centre, Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands.

Department of Gastroenterology and Hepatology, Medical Spectrum Twente, Enschede, The Netherlands.

出版信息

J Crohns Colitis. 2020 Jul 30;14(7):888-895. doi: 10.1093/ecco-jcc/jjaa012.

Abstract

BACKGROUND AND AIMS

There is paucity of data on safety and efficacy of anti-tumour necrosis factor [TNF] in elderly inflammatory bowel disease [IBD] patients. We aimed to compare the long-term treatment failure rates and safety of a first anti-TNF agent in IBD patients between different age groups [<40 years/40-59 years/≥60 years].

METHODS

IBD patients who started a first anti-TNF agent were identified through IBDREAM, a multicentre prospective IBD registry. Competing risk regression was used to study treatment failure, defined as time to drug discontinuation due to adverse events [AEs] or lack of effectiveness, with discontinuation due to remission as a competing risk.

RESULTS

A total of 895 IBD patients were included; 546 started anti-TNF at age <40 [61.0%], 268 at age 40-59 [29.9%], and 81 at age ≥60 [9.1%]. Treatment failure rate was higher in the two older groups (subhazard rate [SHR] age ≥60 1.46, SHR age 40-59 1.21; p = 0.03). The SHR in the elderly [>60] was 1.52 for discontinuation due to AEs and 1.11 for lack of effectiveness. Concomitant thiopurine use was associated with a lower treatment failure rate (SHR 0.78, 95% confidence interval [CI] 0.62-0.98, p = 0.031). Serious adverse event [SAE] rate, as well as serious infection rate, were significantly higher in elderly IBD patients [61.2 versus 16.0 and 12.4 per 1000 patient-years, respectively] whereas the malignancy rate was low in all age groups.

CONCLUSIONS

Elderly IBD patients starting a first anti-TNF agent showed higher treatment failure rates, but concomitant thiopurine use at baseline was associated with lower failure rates. Elderly IBD patients demonstrated higher rates of SAEs and serious infections.

摘要

背景和目的

关于老年炎症性肠病(IBD)患者使用抗肿瘤坏死因子 [TNF] 的安全性和疗效的数据很少。我们旨在比较不同年龄组 [<40 岁/40-59 岁/≥60 岁] 的 IBD 患者使用首种抗 TNF 药物的长期治疗失败率和安全性。

方法

通过多中心前瞻性 IBD 登记处 IBDREAM,确定开始使用首种抗 TNF 药物的 IBD 患者。使用竞争风险回归研究治疗失败,定义为因不良事件 [AE] 或无效而停药的时间,以缓解为竞争风险。

结果

共纳入 895 名 IBD 患者;546 名在<40 岁时开始使用抗 TNF [61.0%],268 名在 40-59 岁时开始 [29.9%],81 名在≥60 岁时开始 [9.1%]。两个较年长组的治疗失败率较高(年龄≥60 岁的亚危险比 [SHR] 为 1.46,年龄 40-59 岁的 SHR 为 1.21;p=0.03)。老年人 [>60 岁] 的 SHR 因 AE 停药为 1.52,因疗效不佳而停药为 1.11。同时使用硫嘌呤与较低的治疗失败率相关(SHR 0.78,95%置信区间 [CI] 0.62-0.98,p=0.031)。老年 IBD 患者的严重不良事件 [SAE] 发生率和严重感染率明显较高[分别为每 1000 患者年 61.2、16.0 和 12.4 例],而所有年龄组的恶性肿瘤发生率均较低。

结论

开始使用首种抗 TNF 药物的老年 IBD 患者的治疗失败率较高,但基线时同时使用硫嘌呤与较低的失败率相关。老年 IBD 患者的 SAE 和严重感染发生率较高。

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