Therapeutic Drug Monitoring for Improving Tuberculosis Treatment Outcomes: A Scoping Review of Clinical Studies

Therapeutic drug monitoring (TDM) is a tool used for dose optimization to achieve therapeutic concentrations associated with improved outcomes. However, evidence supporting its benefits for tuberculosis (TB) treatment remains limited. This scoping review evaluated clinical studies on TDM and its impact on TB treatment outcomes.

A scoping review was performed using a systematic search in PubMed, Embase, Web of Science, ClinicalTrials.gov, and the World Health Organization (WHO) Clinical Trials Registry for interventional and observational studies published until 3 May 2025. We included studies evaluating TDM in adults or children treated for drug-susceptible or drug-resistant TB at any setting worldwide, which reported treatment outcomes, adverse events, or clinical/microbiological surrogate markers. The PRISMA guidelines for scoping reviews were followed to report the findings.

Of the 5820 studies screened by title and abstract, 31 studies from 10 countries were eligible for inclusion in this review. No published clinical trials on the implementation of TDM were identified, although two are currently ongoing. Overall, compared with the non-TDM group, TDM was associated with faster culture conversion (mean 34 versus 49 days), shorter treatment duration (mean 32 versus 36 weeks) and fewer adverse events. Although all included studies reported high treatment success rates (ranging from 67% to 100%), no statistically significant differences were observed in end-of-treatment outcomes between TDM and non-TDM groups. Dose adjustments guided by TDM were recommended by all included studies, despite variability in results.

Observational data suggest that TDM in TB treatment was associated with improved effectiveness and fewer adverse events. However, further investigation through well-controlled studies is needed to minimize potential bias and justify its routine use.