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Assessing safety concerns of interstitial lung disease associated with antibody-drug conjugates: a real-world pharmacovigilance evaluation of the FDA adverse event reporting system

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An Author Correction to this article was published on 17 April 2024

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Abstract

Background

Antibody-drug conjugates have revolutionized cancer therapy due to their selectivity and efficacy. However, concerns have been raised regarding the potential effects of trastuzumab deruxtecan in interstitial lung diseases.

Aim

This study aimed to investigate the safety signals and time to onset of antibody-drug conjugates induced interstitial lung disease.

Method

We utilized the FDA Adverse Event Reporting System database (2004–2022) to identify interstitial lung disease safety signals in 13 FDA-approved antibody-drug conjugates. Disproportionality analysis was conducted to estimate the reporting odds ratios for interstitial lung disease.

Results

Seven antibody-drug conjugates exhibited safety signals of interstitial lung disease: trastuzumab deruxtecan [reporting odds ratio, ROR (95% confidence intervals, CI) = 64.15 (57.07–72.10)], enfortumab vedotin [ROR (95% CI) = 5.24 (3.25–8.43)], trastuzumab emtansine [ROR (95% CI) = 3.62 (2.90–4.53)], brentuximab vedotin [ROR (95% CI) = 3.22 (2.49–4.17)], polatuzumab vedotin [ROR (95% CI) = 2.56 (1.59–4.12)], gemtuzumab ozogamicin [ROR (95% CI) = 2.53 (1.70–3.78)], and inotuzumab ozogamicin [ROR (95% CI) = 2.33 (1.21–4.49)]. Five antibody-drug conjugates with limited reports were excluded from further analysis: belantamab mafodotin, loncastuximab tesirine, mirvetuximab sorafenib, tisotumab vedotin, and moxetumomab pasudotox. Japan and the United States were the primary reporting countries.

Conclusion

This real-world study highlights high safety signals of interstitial lung disease associated with antibody-drug conjugates. Clinicians should be aware of these safety concerns and risk factors and implement early identification measures for their patients. Future research should prioritize comprehensively exploring the relationship between antibody-drug conjugates and lung diseases.

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Funding

This work was supported by the National Natural Science Foundation of China [grant number 82304629], and the Natural Science Foundation of Xiamen, China [Grant Numbers 3502Z202371048, 3502Z20227143].

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Authors and Affiliations

  1. Department of Pharmacy, Women and Children’s Hospital, School of Medicine, Xiamen University, 10# Zhenhai Road, Xiamen, China

    Wanlong Lin, Yufang Liao, Xiuxian Lin, Jianhui Yang & Wei Zhuang

  2. School of Pharmaceutical, Fujian University of Traditional Chinese Medicine, Fuzhou, China

    Jiabing Xu

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  1. Wanlong Lin
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Correspondence to Wei Zhuang.

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The original online version of this article was revised: The corresponding author Prof. Wei Zhuang’s e-mail address is corrected from 'zhuangw8@mail.sysu.edu.cn' to 'zhuangwei1333@gmail.com'.

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Lin, W., Xu, J., Liao, Y. et al. Assessing safety concerns of interstitial lung disease associated with antibody-drug conjugates: a real-world pharmacovigilance evaluation of the FDA adverse event reporting system. Int J Clin Pharm (2023). https://doi.org/10.1007/s11096-023-01673-y

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