Tuberculosis Risk in Patients Treated with Non-Anti-Tumor Necrosis Factor-α (TNF-α) Targeted Biologics and Recently Licensed TNF-α Inhibitors: Data from Clinical Trials and National Registries
Tuberculosis Risk in Patients Treated with Non-Anti-Tumor Necrosis Factor-α (TNF-α) Targeted Biologics and Recently Licensed TNF-α Inhibitors: Data from Clinical Trials and National Registries
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DOI：
10.3899/jrheum.140103
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发表时间：
2014-05-01
影响因子：
3.9
通讯作者：
Goletti, Delia
中科院分区：
文献类型：
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作者：
Cantini, Fabrizio;Niccoli, Laura;Goletti, Delia
本综述旨在评估接受非抗肿瘤坏死因子（TNF）靶向生物制剂阿那白滞素（ANK）、托珠单抗（TCZ）、利妥昔单抗（RTX）、阿巴西普（阿坝）和最近批准的抗TNF戈利木单抗（GOL）和聚乙二醇赛妥珠单抗（CTP）的风湿性疾病患者发生活动性结核（TB）的风险。在最近的研究结果中，在接受抗CD 20 + RTX和抗CD 28阿坝治疗的类风湿性关节炎（RA）和其他风湿性疾病患者中没有记录活动性TB病例。没有接受抗白细胞介素1（IL-1）ANK的患者发生活动性结核病，加拿大数据库中排除了增加的风险。相比之下，在21项RA患者接受抗IL-6 TCZ治疗的试验中观察到8例活动性TB病例，而日本上市后监测未导致TB风险增加。在GOL治疗和CTP治疗的患者中，分别发生了8例和10例活动性结核病例，而登记研究中没有数据。然而，除了1例在接受TCZ、GOL和CTP治疗的患者中记录的TB病例外，所有病例都发生在TB流行国家。ANK、RTX和阿坝均未导致TB风险，表明用于潜伏性TB感染检测的预处理筛查程序是不必要的。由于所有结核病病例都发生在结核病高风险国家，在这些国家，结核病暴露可能发生在治疗期间，因此无法得出TCZ、GOL和CTP的明确结论。
This review aimed to evaluate the risk of active tuberculosis (TB) occurrence in patients with rheumatic disorders receiving non-anti-tumor necrosis factor (TNF) targeted biologics anakinra (ANK), tocilizumab (TCZ), rituximab (RTX), abatacept (ABA), and recently approved anti-TNF golimumab (GOL), and certolizumab pegol (CTP). In recent findings, no cases of active TB were recorded in patients with rheumatoid arthritis (RA) and other rheumatic conditions treated with anti-CD20+ RTX and anti-CD28 ABA. No patient receiving anti-interleukin 1 (IL-1) ANK developed active TB, and an increased risk was excluded in a Canadian database. In contrast, 8 active TB cases were observed in 21 trials of patients with RA receiving anti-IL-6 TCZ, while no increased TB risk resulted from Japanese postmarketing surveillance. Among GOL-treated and CTP-treated patients, 8 and 10 active TB cases occurred, respectively, while no data are available from registries. However, all but 1 TB case recorded in patients treated with TCZ, GOL, and CTP occurred in TB-endemic countries. No TB risk resulted for ANK, RTX, and ABA, suggesting pretreatment screening procedures for latent TB infection detection are unnecessary. Because all TB cases occurred in countries at high risk for TB, where TB exposure could have occurred during treatment, no definitive conclusions can be drawn for TCZ, GOL, and CTP.