Shobha Vineeta, Chandrashekara S, Rao Vijay, Desai Anu, Jois Ramesh, Dharmanand Balebail G, Kumar Sharath, Kumar Pradeep, Dharmapalaiah Chethana, Mahendranath Kurugodu Mathada, Prasad Shiva, Daware Manisha Ashwin, Singh Yogesh, Karjigi Uma, Nagaraj S, Anupama K R
St. John's Medical College Hospital, Bangalore, India.
ChanRe Rheumatology and Immunology Center and Research, Bangalore, India.
Int J Rheum Dis. 2019 Feb;22(2):280-287. doi: 10.1111/1756-185X.13376. Epub 2018 Aug 30.
Tuberculosis (TB) is one of the major adverse events of concern associated with the use of biologics for managing autoimmune inflammatory rheumatic diseases (AIRDs). The study presents the data on incidence of TB in relation to biologic used, screening test and TB prophylaxis in a real-world setting.
The cross-sectional, observational, retrospective study was conducted across 12 centres in Karnataka, India. The study included patients receiving biologics therapy for AIRDs, established based on the respective diagnostic criteria. The development of TB after receiving biologic therapy and other clinical variables and the predictability of the test performed for latent TB were evaluated.
One hundred and ninety-five AIRDs patients with an average age of 41 years were initiated on biologic therapy. Twenty-one patients were latent TB positive and were given antitubercular prophylaxis, prior to biologics treatment. During follow-up, seven patients belonging to the negative test group (n = 174) developed TB. The negative predictive values noted for Mantoux test (n = 120) and quantiFERON TB gold test (n = 178) were 96.52% and 96.25%, respectively. Patients on anti-tumor necrosis factor were more likely to develop TB. Presence of comorbidities and steroid use increased the likelihood of developing TB by 1.5 and 4.6 times, respectively.
Close monitoring of patients receiving biologics is essential for early identification of adverse events, especially in test negative patients. Prophylaxis can effectively reduce the risk of developing TB in patients positive for screening.
结核病（TB）是使用生物制剂治疗自身免疫性炎性风湿性疾病（AIRD）时主要关注的不良事件之一。本研究呈现了在真实世界中，与所用生物制剂、筛查试验及结核病预防相关的结核病发病率数据。
在印度卡纳塔克邦的12个中心开展了一项横断面、观察性、回顾性研究。该研究纳入了根据各自诊断标准确诊为AIRD并接受生物制剂治疗的患者。评估了接受生物制剂治疗后结核病的发生情况、其他临床变量以及针对潜伏性结核病所做检测的可预测性。
195例平均年龄为41岁的AIRD患者开始接受生物制剂治疗。21例患者潜伏性结核呈阳性，在接受生物制剂治疗前接受了抗结核预防治疗。在随访期间，阴性检测组（n = 174）中有7例患者发生了结核病。结核菌素试验（n = 120）和结核感染T细胞检测（n = 178）的阴性预测值分别为96.52%和96.25%。接受抗肿瘤坏死因子治疗的患者更易发生结核病。合并症的存在和使用类固醇分别使发生结核病的可能性增加了1.5倍和4.6倍。
密切监测接受生物制剂治疗的患者对于早期识别不良事件至关重要，尤其是检测结果为阴性的患者。预防措施可有效降低筛查呈阳性患者发生结核病的风险。
