使用生物制剂治疗的普利亚风湿病患者中结核感染的患病率及管理:一项来自BIOPURE注册研究的10年观察性队列研究

Prevalence and management of tuberculosis infection in Apulian rheumatologic patients treated with biologics: An observational cohort 10-year study from the BIOPURE registry.

作者信息

Fornaro Marco, Stano Stefano, Goletti Delia, Semeraro Angelo, Cantatore Francesco Paolo, Maruotti Nicola, Colella Sergio, Abbruzzese Anna, Santo Leonardo, Praino Emanuela, Iannone Florenzo

机构信息

Rheumatology Unit, Department of Emergence Medicine and Transplantation (DETO), University of Bari, Bari, Italy.

Translational Research Unit, National Institute for Infectious Diseases "Lazzaro Spallanzani"- IRCCS, Rome, Italy.

出版信息

Eur J Clin Invest. 2023 Apr;53(4):e13913. doi: 10.1111/eci.13913. Epub 2022 Dec 12.

Abstract

INTRODUCTION

The objective of this study was to assess the 10-year prevalence of latent tuberculosis infection (LTBI) among Apulian patients with rheumatic diseases (RDs). Secondary endpoint was to record new cases of active TB disease and LTBI among patients treated with biologic disease-modifying antirheumatic drugs (bDMARDs).

METHODS

We analysed the results from the patients included in the BIOPURE registry from 2009 to 2018, who underwent QuantiFERON-TB Gold In-tube (QFT-GIT) test as screening before bDMARDs treatment. Demographic and clinical data were recorded at the time of the first QFT-GIT test. Administration of preventive therapy and bDMARD treatments were recorded for patients with positive QFT-GIT test. All new tuberculosis infections were recorded during the follow-up.

RESULTS

The final study population included 3028 patients (855 rheumatoid arthritis, 1001 psoriatic arthritis, 833 spondyloarthritis, 130 connective tissue diseases, 33 systemic vasculitis and 176 other inflammatory rheumatic conditions), more frequently female (67.2%), with a mean age of 52 ± 18 years. Patients with QFT-GIT-positive test were elderly people, predominantly male with higher prevalence of diabetes as comorbidity. The 10-year prevalence of LTBI was 10.8%. Of note, no cases of TB reactivation were recorded in patients who completed preventive therapy treatment. Three thousand and sixteen patients were followed over time (42.6 ± 30 months), and five (.2%) developed active TB, which corresponds to .47 cases per 1000 person-years.

CONCLUSIONS

In the 10-year observation, the use of bDMARDs seems to be safe in rheumatologic patients with positive QFT-GIT test treated according to current recommendations. Nevertheless, cases of primary TB disease did occur during treatment with biologicals.

摘要

引言

本研究的目的是评估普利亚地区风湿性疾病(RD)患者中潜伏性结核感染(LTBI)的10年患病率。次要终点是记录接受生物改善病情抗风湿药物(bDMARDs)治疗的患者中活动性结核病和LTBI的新发病例。

方法

我们分析了2009年至2018年纳入BIOPURE注册研究的患者的结果,这些患者在接受bDMARDs治疗前接受了QuantiFERON-TB Gold In-tube(QFT-GIT)检测作为筛查。在首次进行QFT-GIT检测时记录人口统计学和临床数据。对QFT-GIT检测呈阳性的患者记录预防性治疗和bDMARDs治疗的情况。在随访期间记录所有新的结核感染情况。

结果

最终研究人群包括3028名患者(855例类风湿性关节炎、1001例银屑病关节炎、833例脊柱关节炎、130例结缔组织病、33例系统性血管炎和176例其他炎性风湿性疾病),女性更为常见(67.2%),平均年龄为52±18岁。QFT-GIT检测呈阳性的患者为老年人,男性居多,合并糖尿病的患病率较高。LTBI的10年患病率为10.8%。值得注意的是,完成预防性治疗的患者中未记录到结核复发病例。3016名患者接受了长期随访(42.6±30个月),5例(0.2%)发生了活动性结核病,相当于每1000人年0.47例。

结论

在10年的观察中,对于QFT-GIT检测呈阳性的风湿性疾病患者,按照当前建议使用bDMARDs似乎是安全的。然而,在生物制剂治疗期间确实发生了原发性结核病病例。

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