Department of Gastroenterology, Xiasha Branch of Sir Run Run Shaw Hospital, College of Medicine Zhejiang University, Hangzhou, China.
Translational Gastroenterology Unit, NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK.
Aliment Pharmacol Ther. 2021 Feb;53(3):390-399. doi: 10.1111/apt.16130. Epub 2020 Dec 12.
Anti-tumour necrosis factor (anti-TNF) therapy increases the risk of tuberculosis (TB). Given limitations of screening techniques, it remains uncertain if patients receiving anti-TNF in TB endemic regions should be screened for latent infection with chemoprophylaxis restricted to those with proven infection, or if all patients should receive chemoprophylaxis.
To compare the incidence of active TB with infliximab (IFX) following targeted and universal TB chemoprophylaxis, and to determine the rates of adverse events (AE) related to TB chemoprophylaxis METHODS: A multi-centre retrospective cohort study was performed at 18 hospitals in China of 1968 adult patients with IBD receiving IFX from 2009 to 2017. TB screening prior to IFX was performed with chest X-ray and/or computed tomography [CT] and immune reactivity testing (interferon-γ release assay and/or tuberculin skin test). Patients were followed-up for a minimum of 3 months after IFX discontinuation, or until last hospital visit if IFX therapy was ongoing. Targeted strategy was defined as TB chemoprophylaxis only for patients with a positive latent TB screen, with universal strategy defined as TB chemoprophylaxis for all patients.
Mean follow-up was 1.07 ± 0.87 years with a total follow-up of 2102 patient-years. There were 1433 patients in the targeted and 483 patients in the universal TB chemoprophylaxis groups, with no significant difference in the incidence rates of active TB between groups (673.3 per 100 000 population per year vs 891.5 per 100 000 population per year, P = 0.60). In the targeted group, 55/1433 patients received TB chemoprophylaxis compared with 483/483 in the universal group, with significantly fewer AEs related to TB chemoprophylaxis in the targeted compared to the universal group (0.35% (5/1433) vs 6.8% (33/483), P < 0.05).
In this study of patients receiving IFX in a TB endemic area, universal chemoprophylaxis was not associated with a reduced risk of active TB when compared to a targeted chemoprophylaxis strategy, and AEs were more common. This supports the use of targeted TB chemoprophylaxis when anti-TNF therapy is initiated in TB endemic regions.
抗肿瘤坏死因子(anti-TNF)治疗会增加结核(TB)的风险。鉴于筛查技术的局限性,目前仍不确定在结核病流行地区接受抗 TNF 治疗的患者是否应进行潜伏性感染筛查,并对确证感染的患者进行化学预防,还是应所有患者都接受化学预防。
比较目标性和普遍性 TB 化学预防后英夫利昔单抗(IFX)治疗后活动性 TB 的发生率,并确定与 TB 化学预防相关的不良事件(AE)的发生率。
本研究为在中国 18 家医院开展的一项多中心回顾性队列研究,共纳入 1968 例于 2009 年至 2017 年接受 IFX 治疗的 IBD 成年患者。在开始 IFX 治疗前,通过 X 线胸片和/或计算机断层扫描[CT]和免疫反应性检测(干扰素-γ释放试验和/或结核菌素皮肤试验)进行 TB 筛查。患者在 IFX 停药后至少随访 3 个月,或 IFX 治疗持续进行时随访至最后一次医院就诊。目标策略定义为仅对潜伏性 TB 筛查阳性的患者进行 TB 化学预防,而普遍策略定义为对所有患者进行 TB 化学预防。
中位随访时间为 1.07±0.87 年,总随访时间为 2102 患者-年。目标性 TB 化学预防组有 1433 例患者,普遍性 TB 化学预防组有 483 例患者,两组的活动性 TB 发生率无显著差异(每年每 100000 人口 673.3 例 vs 每年每 100000 人口 891.5 例,P=0.60)。在目标性 TB 化学预防组,有 55/1433 例患者接受了 TB 化学预防,而在普遍性 TB 化学预防组有 483/483 例患者接受了 TB 化学预防,与普遍性 TB 化学预防组相比,目标性 TB 化学预防组与 TB 化学预防相关的 AE 明显较少(0.35%(5/1433)vs 6.8%(33/483),P<0.05)。
在这项对结核病流行地区接受 IFX 治疗的患者进行的研究中,与目标性化学预防策略相比,普遍性化学预防策略并未降低活动性 TB 的风险,且 AE 更为常见。这支持在结核病流行地区开始抗 TNF 治疗时使用目标性 TB 化学预防。