Murrill Matthew T, Velásquez Gustavo E, Szumowski John D, Phillips Allison, Kim Annie, Yazdany Jinoos, Roberts Eric T, Habib Anand R, Batlle Haiyan Ramirez, Salazar Jorge, Minter Daniel J, Louie Janice K, Ernst Joel D
Division of Hospital Medicine, University of California, San Francisco, San Francisco, CA, USA.
UCSF Center for Tuberculosis, Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.
medRxiv. 2025 Jul 25:2025.07.25.25332013. doi: 10.1101/2025.07.25.25332013.
Targeted immunotherapies have transformed the treatment of many diseases. However, some increase the risk of tuberculosis (TB) disease. We sought to develop a comprehensive list of targeted immunotherapies with TB infection screening recommendations in U.S. Food and Drug Administration (FDA)-approved prescribing information and compare these recommendations to clinical resources and quality measures.
Through a grey literature review, we identified TB clinical resources and U.S. quality measures. We created a list of targeted immunotherapies and TB infection screening recommendations by analyzing four FDA databases. We then evaluated the consistency of screening recommendations in prescribing information, TB clinical resources and quality measures.
We identified six TB clinical resources and one quality measure for TB infection. While TB infection screening recommendations for tumor necrosis factor (TNF) inhibitors were consistently included, recommendations for other therapies were less consistent. Through FDA database analyses, we identified 269 targeted immunotherapies, 35 (13%) of which had TB infection screening recommendations in prescribing information, including all therapies targeting TNF and several interleukins (IL); however, therapies targeting IL-6, Janus-associated kinase and others had variable recommendations. Significant discordance in screening recommendations for immunotherapies were further identified when comparing prescribing information, clinical resources and quality measures.
The number and targets of immunotherapies are rapidly evolving resulting in challenges with creating, up-to-date and consistent TB infection screening recommendations. Inconsistent recommendations in clinical resources may contribute to gaps in TB preventive care. Harmonized recommendations and additional epidemiologic studies of TB disease risk with the use of these agents are needed.
靶向免疫疗法已经改变了许多疾病的治疗方式。然而，一些疗法会增加结核病（TB）发病的风险。我们试图在美国食品药品监督管理局（FDA）批准的处方信息中制定一份包含结核病感染筛查建议的靶向免疫疗法综合清单，并将这些建议与临床资源和质量指标进行比较。
通过灰色文献综述，我们确定了结核病临床资源和美国质量指标。通过分析四个FDA数据库，我们创建了一份靶向免疫疗法和结核病感染筛查建议清单。然后，我们评估了处方信息、结核病临床资源和质量指标中筛查建议的一致性。
我们确定了六种结核病临床资源和一项结核病感染质量指标。虽然肿瘤坏死因子（TNF）抑制剂的结核病感染筛查建议始终被纳入，但其他疗法的建议则不太一致。通过FDA数据库分析，我们确定了269种靶向免疫疗法，其中35种（13%）在处方信息中有结核病感染筛查建议，包括所有靶向TNF的疗法和几种白细胞介素（IL）；然而，靶向IL-6、Janus相关激酶等的疗法的建议各不相同。在比较处方信息、临床资源和质量指标时，进一步发现免疫疗法筛查建议存在显著差异。
免疫疗法的数量和靶点正在迅速演变，这给制定最新且一致的结核病感染筛查建议带来了挑战。临床资源中不一致的建议可能导致结核病预防保健的差距。需要统一的建议以及对使用这些药物的结核病发病风险进行更多的流行病学研究。
