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ORIGINAL RESEARCH article

Front. Med.
Sec. Pulmonary Medicine
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1390083
This article is part of the Research Topic Reviews in: Pulmonary Medicine 2023 View all 9 articles

Regional diversity in drug-induced lung diseases among the USA, European Union, and Japan

Provisionally accepted
Jun Sato Jun Sato 1*Ryo Sadachi Ryo Sadachi 2Takafumi Koyama Takafumi Koyama 3Yuki Katsuya Yuki Katsuya 3Mao Okada Mao Okada 3Noboru Yamamoto Noboru Yamamoto 3
  • 1 Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan
  • 2 Biostatistics Division, Center for Research Administration and Support, National Cancer Centre (Japan), Tokyo, Japan
  • 3 Department of Experimental Therapeutics, National Cancer Centre (Japan), Tokyo, Japan

The final, formatted version of the article will be published soon.

    Background: Drug-induced lung disease (DILD) is a considerable and potentially fatal adverse event with poorly understood risk factors. Large-scale, data-driven analyses investigating regional discrepancies in DILD incidence are lacking. The aim of this study was to investigate the potential association among DILD prevalence, regional differences and other factors based on large-scale data base. Methods: This retrospective observational study analyzed spontaneous adverse event reports from the FDA Adverse Event Reporting System (FAERS) database between January 2010 and December 2020. Regional disparities in DILD incidence were assessed among reports from the United States of America (USA), the European Union (EU), and Japan (JP). Using multivariate logistic regression accounting for age, sex, and reporting years, we calculated the reporting odds ratios (RORs) with 95% confidence intervals. Subgroup analyses were performed for different types of anticancer agents, including tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), antibody-drug conjugates (ADCs), and cytotoxic agents. Results: Regional differences in RORs were observed for anticancer drugs in reports from JP and the EU compared with those from the USA (JP, ROR 4.432; EU, ROR 1.291) and for non-anticancer drugs (JP, ROR 3.481; EU, ROR 1.086). Significantly higher RORs were observed for all anticancer drug regimens reported in JP than in the USA (TKIs, ROR 3.274; ICIs, ROR 2.170; ADCs, ROR 2.335; cytotoxic agents, ROR 3.989). The EU reports exhibited higher RORs for TKIs and cytotoxic agents than the USA reports, with no significant differences in ICIs or ADCs (TKIs, ROR 1.679; ICIs, ROR 1.041; ADCs, ROR 1.046; cytotoxic agents, ROR 1.418). Conclusions: The prevalence of DILD in JP, the EU, and the USA differed. These findings have important implications in evaluating the safety profiles of drugs and patient safety in drug development and clinical practice. This study is the first to identify regional differences in DILDs using a large global database.

    Keywords: Drug-induced lung disease, FDA Adverse Event Reporting System, ethnic diversity, Interstitial Lung Disease, Real-world data

    Received: 22 Feb 2024; Accepted: 13 Sep 2024.

    Copyright: © 2024 Sato, Sadachi, Koyama, Katsuya, Okada and Yamamoto. 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: Jun Sato, Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.