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. 2023 May 5:946:175561.
doi: 10.1016/j.ejphar.2023.175561. Epub 2023 Feb 1.

Immune-related interstitial lung disease induced by different immune checkpoint inhibitors regimens: A real-world study from 2014 to 2022 based on FAERS databases

Chanjuan Cui  1 , Siyu Zhang  2 , Xiayang Ren  3 , Wei Cui  4 , Yanfeng Wang  5
Affiliations

Immune-related interstitial lung disease induced by different immune checkpoint inhibitors regimens: A real-world study from 2014 to 2022 based on FAERS databases

Chanjuan Cui et al. Eur J Pharmacol. .

Abstract

This study further approaches immune-related interstitial lung disease adverse event in patients undergoing immune checkpoint inhibitor (ICI) monotherapy, ICI plus chemotherapy and ICI plus anti-VEGF therapy in the postmarketing period. Reports for ICI-related interstitial lung disease adverse event from the FDA Adverse Event Reporting System (FAERS) database between 2014 and 2022 were analysed in this study. The reporting odds ratio (ROR) and Bayesian confidence propagation neural networks of information components (IC) were computed to identify disproportionate reporting of ICI-related interstitial lung disease. 44,964,609 records were extracted from the FAERS database, with 9150 records for interstitial lung disease after ICI treatment. Men had a slightly higher reporting frequency than women (63.07% vs. 25.69%). The morbidity rate (2.05%) of acute respiratory distress syndrome was low, the fatality rate (67.55%) was the highest, the time to onset was relatively short. Within 3 months, the cumulative proportion of ICI-related interstitial lung disease records was 75.03%. The ICI plus anti-VEGF therapy group had the lowest frequency of interstitial lung disease adverse events compared to the ICI monotherapy group and the ICI plus chemotherapy group (IC025 = 1.72, IC025 = 3.21, IC025 = 3.22). Moreover, ICI plus anti-VEGF therapy group had the narrowest spectrum of interstitial lung disease among these three therapeutic regimens. This study showed substantial characteristics of a spectrum of interstitial lung disease adverse events after different ICI regimens. Notably, ICI plus anti-VEGF therapy might be a treatment method that can to some extent control ICI-related interstitial lung disease. These data provide some important information for clinicians to weigh the risks and benefits of different ICI regimens.

Keywords: Adverse events; Cancer; FAERS; Immune checkpoint inhibitors; Interstitial lung disease.

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Conflict of interest statement

Declaration of competing interest We would like to submit the enclosed manuscript entitled “Immune-related Interstitial Lung Disease Induced by Different Immune Checkpoint Inhibitors Regimens: a Real-world Study from 2014 to 2022 based on FAERS databases”, 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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