Background: Clinical trials of ustekinumab in western countries rarely reported active tuberculosis. South Korea, however, is a nation with high tuberculosis burden unlike western countries. The real-world risk of active tuberculosis for ustekinumab users in high tuberculosis burden area has not been evaluated.
Objectives: This study aims to identify the incidence of active TB in patients using ustekinumab in Korea and to compare it with the incidence of TB in Korea general population.
Methods: The claim data of patients who received ustekinumab from January 2012 to December 2018, from National Health Insurance Service in Korea was analyzed. Patients prescribed triple or quadruple anti-TB medications with diagnosis codes of tuberculosis were defined as active TB in this study.
Results: Total 2,803 patients (M/F: 1,904/899) received ustekinumab. Ustekinumab treatment was started at average 45.25±12.99 (mean±standard deviation) years old and was performed for an average of 691.09±647.22 days. Our study found three cases of active tuberculosis associated with ustekinumab. The incidence of ustekinumab associated tuberculosis was low comparted to the sex and age-adjusted expected tuberculosis incidence estimation (3.945 cases) based on the 2016 annual reports from Korean Centers for Disease Control and Prevention.
Conclusion: Our study showed that the risk of TB is not increased by ustekinumab even in a high tuberculosis burden area