接受抗肿瘤坏死因子治疗的患者患结核病的风险：在韩国这个结核病负担中等的国家进行的一项全国性研究。

Risk of tuberculosis in patients treated with anti-tumor necrosis factor therapy: a nationwide study in South Korea, a country with an intermediate tuberculosis burden.

作者信息

Jung Seung Min, Ju Ji Hyeon, Park Mi-Sun, Kwok Seung-Ki, Park Kyung-Su, Kim Ho-Youn, Yim Hyeon Woo, Park Sung-Hwan

机构信息

Division of Rheumatology, Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea.

出版信息

Int J Rheum Dis. 2015 Mar;18(3):323-30. doi: 10.1111/1756-185X.12530. Epub 2015 Jan 3.

DOI:10.1111/1756-185X.12530

PMID:25557144

Abstract

AIM

The aim of this study was to investigate the incidence of tuberculosis (TB) following anti-tumor necrosis factor (TNF) therapy in an intermediate TB burden area and to compare the risk between drugs and diseases.

METHODS

The data were obtained from a nationwide database maintained by the Health Insurance Review and Assessment Service. The study population comprised of patients who were prescribed with TNF inhibitors from 2005 to 2009. TB cases were selected based on prescription of anti-TB medications.

RESULTS

Of 8421 patients in the study population, 1729 patients with latent TB prophylaxis were identified and 102 patients developed TB. The incidence of TB was 1017 per 100 000 person-years. When divided into four groups according to the main diagnosis and using an ankylosing spondylitis group as a reference, the incidence of TB was highest in patients with inflammatory bowel disease (IBD) (incidence rate ratio [IRR] 5.97, 95% confidence interval [CI] 3.34-10.66), followed by patients with rheumatoid arthritis (IRR 1.02, 95% CI 0.57-1.83) and those with psoriatic arthritis (IRR 1.00, 95% CI 0.14-7.30). Comparison between drugs showed a significantly lower incidence of TB in patients treated with etanercept (reference), highest incidence in those treated with infliximab (IRR 6.8, 95% CI 3.74-12.37) and an intermediate incidence in patients treated with adalimumab (IRR 3.45, 95% CI 1.82-6.55).

CONCLUSIONS

The difference in TB risk between TNF inhibitors was similar with countries of low TB burden. This study suggests that particular attention is required for patients treated with TNF monoclonal antibodies.

摘要

目的

本研究旨在调查中度结核病负担地区接受抗肿瘤坏死因子（TNF）治疗后结核病（TB）的发病率，并比较药物与疾病之间的风险。

方法

数据来自健康保险审查与评估服务机构维护的全国性数据库。研究人群包括2005年至2009年期间开具TNF抑制剂处方的患者。根据抗结核药物处方选择结核病病例。

结果

在研究人群的8421名患者中，确定了1729名接受潜伏性结核预防治疗的患者，其中102名患者发生了结核病。结核病发病率为每10万人年1017例。根据主要诊断分为四组，并以强直性脊柱炎组作为对照，炎症性肠病（IBD）患者的结核病发病率最高（发病率比[IRR]5.97，95%置信区间[CI]3.34-10.66），其次是类风湿性关节炎患者（IRR 1.02，95%CI 0.57-1.83）和银屑病关节炎患者（IRR 1.00，95%CI 0.14-7.30）。药物之间的比较显示，接受依那西普治疗的患者结核病发病率显著较低（对照），接受英夫利昔单抗治疗的患者发病率最高（IRR 6.8，95%CI 3.74-12.37），接受阿达木单抗治疗的患者发病率居中（IRR 3.45，95%CI 1.82-6.55）。