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. 2025 Nov 5:1006:178156.
doi: 10.1016/j.ejphar.2025.178156. Epub 2025 Sep 12.

Analysis of pulmonary adverse events associated with immune checkpoint inhibitors based on FAERS and VigiBase database

Zi-Mu Li  1 , Yi-Fan Zheng  2 , Pei-Hang Xu  3 , Ji-Yu Wang  3 , Rong-Ling He  3 , Hui-Xia Li  3 , Yu-Kun Kuang  3 , Li-Hong Bai  3 , Ke-Jing Tang  4
Affiliations

Analysis of pulmonary adverse events associated with immune checkpoint inhibitors based on FAERS and VigiBase database

Zi-Mu Li et al. Eur J Pharmacol. .

Abstract

This study investigates pulmonary immune-related adverse events (pirAEs) in patients undergoing immune checkpoint inhibitors (ICIs), including anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies. Reports for pirAEs from the Food and Drug Administration Adverse Event Reporting System (FAERS) and the World Health Organization Global Database on Case Safety Reporting (VigiBase) between the first quarter of 2015 and the second quarter of 2020 were analyzed.16,372 and 7,943 individual case safety reports (ICSRs)were collected using FAERS database and VigiBase database, respectively. More than 50 % of pirAEs occurred within 60 days after treatment with ICIs, and their mortality was higher than that after 60 days. In each period after the use of ICIs, pirAEs with the highest incidence were interstitial lung disease, dyspnoea, and pneumonitis. The all-cause mortality of respiratory failure, pulmonary hemorrhage, acute interstitial pneumonitis, and stridor was over 25 %. The mortality of respiratory failure remained stable at a high level in each period after initiation of immunotherapy, of which the mortality was still 40 % after one year of initiation of immunotherapy. This study can better help physicians understand the types and mortality rate of pirAEs at each period after using such drugs, particularly during the initial 60 days of ICI therapy, so as to achieve early identification and treatment.

Keywords: FAERS; Immune checkpoint inhibitors; Pulmonary immune-related adverse events; VigiBase.

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Conflict of interest statement

Declaration of competing interest We would like to submit the enclosed manuscript entitled “Analysis of pulmonary adverse events associated with immune checkpoint inhibitors based on FAERS and VigiBase database”, which we wish to be considered for publication in “European journal of pharmacology”. No conflict of interest exits in the submission of this manuscript, and manuscript is approved by all authors for publication. I would like to declare on behalf of my co-authors that the work described was original research that has not been published previously, and not under consideration for publication elsewhere, in whole or in part. All the authors listed have approved the manuscript that is enclosed.

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