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Pulmonary tuberculosis associated with immune checkpoint inhibitors: a pharmacovigilance study
  1. Jianhong Zhu1,2,
  2. Zhichao He1,2,
  3. Dan Liang1,2,
  4. Xiaoxia Yu1,2,
  5. Kaifeng Qiu1,2,
  6. Junyan Wu1,2
  1. 1 Department of Pharmacy, Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China
  2. 2 Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, People's Republic of China
  1. Correspondence to Dr Junyan Wu, Sun Yat-Sen Memorial Hospital, Guangzhou 510123, Guangdong, China; wujunyan{at}


We examined case reports of immune checkpoint inhibitors (ICIs) associated pulmonary tuberculosis (PT) using data from the Food and Drug Administration Adverse Event Reporting System database. Disproportionality analysis was performed by using the reporting OR (ROR) with relevant 95% CI. A total of 74 cases of PT related to ICIs therapy were identified. ICIs were significantly associated with over-reporting frequencies of PT (ROR=3.16, 95% CI: 2.51 to 3.98), while the signal was differed between anti-programmed death-1/ligand-1 and anti-cytotoxic T lymphocyte antigen-4 agents. Most indications were lung cancer (64.9%), the median onset age was 70 years, the median time to onset of PT was 70 days, ICIs were discontinued in most cases (85.2%).

  • tuberculosis

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  • JZ, ZH and DL contributed equally.

  • Contributors JW had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. JZ and JW contributed to study concept and design. JZ, DL and ZH contributed to acquisition of data. JZ, DL, ZH, XY, KQ, JW contributed to analysis and interpretation of data. JZ, DL, ZH, XY, KQ, JW contributed to drafting of the manuscript. JZ, ZH contributed to statistical analysis.

  • Funding Research Fund of Guangdong Pharmaceutical Association (2021ZX01).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.