ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
This article is part of the Research TopicPharmacist and patient safety: Focus on drug safetyView all 12 articles
Tuberculosis infection following administration of immune checkpoint inhibitors: a real world observational study
Provisionally accepted
- 1Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China
- 2West China Hospital of Sichuan University, Chengdu, China
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Background: This study aims to investigate the incidence of tuberculosis (TB) infection following administration of immune checkpoint inhibitors (ICI) and to explore the risk factors for developing TB in patients treated with ICIs. Research design and methods: We conducted a retrospective review of patients who had ICI until June 2023. Patient follow-up was extended until death or on July, 2025. The primary outcome was the incidence of TB infection in patients treated with ICIs. Logistic regression was used to investigate the associations between clinical characteristics and TB infection after ICI initiation. Results: Of the 8,199 patients analyzed, 2.65% had a pre-existing TB diagnosis. The incidence of TB following ICI initiation was 1.96%, with pulmonary TB being the most frequent presentation. Logistic regression revealed that pre-existing TB (OR 3.277; [95% CI, 1.822–5.895]; p<0.001) and male sex (OR 1.798; [95% CI, 1.173–2.756]; p=0.007) were significantly associated with TB following ICI initiation. Conclusions: In this large, real-world cohort of cancer patients receiving ICI therapy, we observed a notable incidence of tuberculosis. These findings suggest that enhanced clinical vigilance may be warranted for these high-risk populations, and they highlight the need for prospective, controlled studies to definitively quantify the excess TB risk attributable to ICI therapy.
Keywords: immune checkpoint inhibitors, Tuberculosis, Retrospective study, Immune-related adverse events, Risk factors
Received: 12 Sep 2025; Accepted: 03 Nov 2025.
Copyright: © 2025 Zhan, Zhou, Liu, Long, Huang, Xu and Fu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Mei Zhan, mandyzhanmei@163.com
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