PT - JOURNAL ARTICLE AU - Seongman Bae AU - Ye-Jee Kim AU - Min-ju Kim AU - Jwa Hoon Kim AU - Sung-Cheol Yun AU - Jiwon Jung AU - Min Jae Kim AU - Yong Pil Chong AU - Sung-Han Kim AU - Sang-Ho Choi AU - Yang Soo Kim AU - Sang-Oh Lee TI - Risk of tuberculosis in patients with cancer treated with immune checkpoint inhibitors: a nationwide observational study AID - 10.1136/jitc-2021-002960 DP - 2021 Sep 01 TA - Journal for ImmunoTherapy of Cancer PG - e002960 VI - 9 IP - 9 4099 - http://jitc.bmj.com/content/9/9/e002960.short 4100 - http://jitc.bmj.com/content/9/9/e002960.full SO - J Immunother Cancer2021 Sep 01; 9 AB - Background While some recent studies have reported the development of tuberculosis (TB) in patients exposed to immune checkpoint inhibitors (ICIs), there is limited evidence to date. Therefore, we evaluated the risk of TB in patients with cancer exposed to ICIs using the National Health Insurance claims data in South Korea.Methods Patients with diagnostic codes for non-small cell lung cancer, urothelial carcinoma or melanoma between August 2017 and June 2019 were identified. The incidence rate and standardized incidence ratio (SIR) of TB were calculated for both the ICI exposure and non-exposure groups. The risk of TB according to ICI exposure was assessed using a multivariable Cox regression model.Results During the study period, 141 550 patients with cancer and 916 new TB cases were identified. Among the 5037 patients exposed to ICIs, 20 were diagnosed with TB at a median of 2.2 months after the ICI was initiated. The crude incidence rate of TB per 100,000 person-years was 675.8 (95% CI 412.8 to 1043.8) for the ICI exposure group and 599.1 (95% CI 560.5 to 639.6) for the non-exposure group. The SIR for TB was 8.1 (95% CI 8.0 to 8.2) in the ICI exposure group. After adjusting for potential confounding factors, ICI treatment was not significantly associated with an increased risk of TB (HR: 0.73; 95% CI 0.47 to 1.14).Conclusions While the incidence of TB in cancer patients exposed to ICIs was eightfold higher than in the general population, the risk of patients with cancer developing TB did not significantly differ according to ICI exposure.Data are available at https://opendata.hira.or.kr/ with permission from the Health Insurance Review and Assessment Service (HIRA). Data are provided by the HIRA after reviewing the researcher's request for academic purposes. The data used in this article were provided by the Health Insurance Review and Assessment Service of Korea at the request of the authors [https://opendata.hira.or.kr].