Confusion over TB screening for targeted immunotherapies

Targeted immunotherapies have transformed treatment for many conditions, but some of these drugs raise the risk of tuberculosis (TB) disease. To understand how clinicians are being guided about TB prevention, a team led by Matthew Murrill set out to compile a comprehensive list of targeted immunotherapies that include TB infection screening recommendations in U.S. Food and Drug Administration (FDA)-approved prescribing information. The group wanted not only to see what drug labels say, but to compare those recommendations against clinical reference resources and formal quality measures used in the United States. The work responds to a practical problem: new immunotherapies are being developed and prescribed rapidly, and clinicians need clear, consistent guidance on when to screen patients for TB infection before starting these drugs. By focusing on what is included in official prescribing information and consulting clinical resources and quality measures, the researchers aimed to reveal gaps or inconsistencies that could lead to missed opportunities for TB prevention.

The researchers performed a grey literature review to identify TB clinical resources and U.S. quality measures, and they analyzed four FDA databases to build their list of targeted immunotherapies and their TB infection screening recommendations. From the clinical resources and quality measure search they identified six TB clinical resources and one quality measure addressing TB infection screening. Their FDA database analysis found 269 targeted immunotherapies overall. Of those, 35 (13%) had TB infection screening recommendations in their prescribing information. The findings showed that TB infection screening recommendations were consistently included for tumor necrosis factor (TNF) inhibitors, and that several therapies targeting interleukins (IL) also included guidance. However, therapies targeting IL-6, Janus-associated kinase and other targets showed variable or absent recommendations. When the team compared prescribing information to clinical resources and the single quality measure they found significant discordance in screening recommendations across these sources.

These results highlight a practical challenge for clinicians and health systems: the number and molecular targets of immunotherapies are evolving quickly, and guidance about TB infection screening is not keeping pace in a consistent way. Inconsistent recommendations across FDA prescribing information, clinical resources and quality measures may contribute to gaps in TB preventive care, meaning some patients who would benefit from screening and treatment for TB infection before starting certain immunotherapies might be missed. The authors conclude that harmonized screening recommendations and additional epidemiologic studies to clarify the risk of TB disease associated with use of these agents are needed. Better alignment of prescribing information, respected clinical resources and quality measures would help clinicians make safer choices for patients starting targeted immunotherapies.