Postmarketing adverse events of biologics and Janus kinase inhibitors in patients with atopic dermatitis.

BACKGROUND: New targeted drugs, including biologics and Janus kinase inhibitors (JAKi), have been approved for the treatment of atopic dermatitis (AD). Given their widespread clinical use, a comprehensive real-world study of their adverse events (AEs) is warranted.

OBJECTIVES: This study aims to characterize of new targeted drugs related AEs, and to compare the AE profiles of biologics and JAKi.

METHODS: Disproportionality metrics, including the reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean, were employed to determine AE signals. The most recent case reports were all included, and data was included until third quarter of 2024.

RESULTS: A total of 99,043 biologics-related and 3,897 JAKi-related AEs were identified. Biologics-specific AEs, including injection reaction and eye disorders, were worthy noted. Several JAKi specific AEs also need to be noticed, including infection, gastrointestinal perforation, precancerous condition, pulmonary thrombosis, embolism venous, and pulmonary tuberculosis. Biologics exhibited more number of positive AE signals compared to JAKi, but the serious AEs are more frequently reported in JAKi than biologics (P&#x2009;<&#x2009;0.01).

CONCLUSION: Our study could provide a comprehensive safety overview of biologics and JAKi during AD treatment, and provide valued evidence for healthcare professionals to select these drugs for AD patients.