ArticlemedRxiv : the preprint server for health sciences2025
Tuberculosis infection screening recommendations for targeted immunotherapies: comparison of U.S. prescribing information, clinical resources and quality measures.
Article in medRxiv : the preprint server for health sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: 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. Methods: 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. Results: 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. Conclusions: 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.
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