Tuberculosis with tofacitinib: Analysis of adverse drug reaction reporting trends in the World Health Organisation global drug safety database

Objectives: Tofacitinib, a first-generation Janus Kinase (JAK) inhibitor, was approved in 2012 by the United States Food and Drug Administration for various arthritic disorders. However, it is used for several other indications as well. Tuberculosis (TB) is a listed serious adverse drug reaction of tofacitinib. This study evaluated the global reporting pattern of TB with tofacitinib use in the World Health Organisation global drug safety database (VigiBase). Materials and Methods: We performed a Vigilyze search on 21 January 2025 using the following search criteria: Drug-tofacitinib (active ingredient) and Reaction-TB (Preferred Term). The following outcome data were analysed-total number of reports, reporting countries, dechallenge and rechallenge information, seriousness and fatalities. Information component (IC value) and lower bound (IC025) were noted for signal detection. Results: A total of 234 individual case safety reports with TB as an adverse reaction were noted worldwide, and only four were from India. About 68% were healthcare professional reporters. About 45.3% of the patients were in the 45–64 years age-group with female preponderance (67.9%). There were 228 serious cases with four fatalities. The most common co-administered drug was methotrexate (11.5%). The IC value was 2.3, and IC025 was 2.2, indicating that it could be considered statistically as a ‘signal.’ Conclusion: This study highlights the importance of screening and close monitoring of patients on tofacitinib to ensure the early detection of TB. It also re-emphasises the need for routine screening for TB before initiating therapy, especially in countries like India, where the prevalence of TB is high.