ORIGINAL RESEARCH article
Front. Med.
Sec. Dermatology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1694688
This article is part of the Research TopicExploring Cutaneous Drug-Related and Drug-Associated Adverse Events: From Clinical Insight to Therapeutic ManagementView all 4 articles
Association Between Oral JAK-1 Inhibitors and Infection Risks in Atopic Dermatitis: A Retrospective Analysis of the FAERS Database
Provisionally accepted
- Peking University People's Hospital, Beijing, China
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Background: Janus kinase (JAK)-1 inhibitors have been approved for moderate-to-severe atopic dermatitis (AD). Despite favorable efficacy, their real-world infection risk profile require further investigation. Methods: We conducted a retrospective disproportionality analysis using the U.S. FDA Adverse Event Reporting System (FAERS) database. Reports identifying upadacitinib or abrocitinib as primary suspect drugs for "Infections and Infestations" adverse events (AEs) in AD treatment (from Q3 2019 to Q1 2025) were included. Four disproportionality methods were employed to detect infection-related safety signals. Result: 18 infection-related positive safety signals associated with abrocitinib were identified, which including known AEs (herpes zoster, eczema herpeticum, and herpes simplex) and unexpected signals (sepsis, appendicitis, septic shock). Upadacitinib showed 64 infection-related signals, encompassing known AEs (herpes zoster, pneumonia, influenza) and unexpected signals (sepsis, appendicitis, septic shock). Herpes zoster was the most frequent infection-related AE for both drugs. Conclusion: This study confirms established infection risks of JAK-1 inhibitors in AD (particularly herpes zoster) and identified novel potential safety signals (sepsis, appendicitis, septic shock). These findings provide real-world insights into the risk of infections associated with JAK inhibitors
Keywords: Janus kinase inhibitors, atopic dermatitis, adverse events, FAERS database, Infection
Received: 28 Aug 2025; Accepted: 13 Oct 2025.
Copyright: © 2025 Tang, Mu, Wang and Zhao. 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: Yan Zhao, zhaoyan377@hotmail.com
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