Comprehensive pharmacovigilance analysis of lebrikizumab: a real-world safety assessment based on the FDA Adverse Event Reporting System (FAERS) database.

Abstract

Background: Lebrikizumab is an interleukin-13 antagonist that has been approved for use in adults and pediatric patients aged 12 years and over who weigh at least 40 kg, for the treatment of moderate-to-severe atopic dermatitis (AD) that is inadequately controlled with topical prescription therapies, or for whom such therapies are not suitable. Due to the relatively short duration of existing clinical trials and the absence of real-world postmarketing evidence involving AD patients receiving lebrikizumab, it is crucial to comprehensively characterize its safety profile, including the potential delayed adverse events (AEs).

Methods: AE signals were identified using disproportionality analysis with four algorithms: the reporting odds ratio (ROR), the proportional reporting ratio, the information component, and the empirical Bayesian geometric mean. Data were analyzed from the FDA Adverse Event Reporting System, covering the period from the fourth quarter of 2024 to the third quarter of 2025.

Results: A total of 791 AEs associated with lebrikizumab were identified. Lebrikizumab was documented in a lower proportion of serious AEs, accounting for 15.68% of cases. The three most frequently reported AEs associated with lebrikizumab were injection site pain, conjunctivitis, and rash. The top three AE signals with ROR values were conjunctivitis, eyelid irritation and dermatitis exfoliative generalized. Specific AEs of lebrikizumab included hypersensitivity, eosinophilia, and injection site reactions.

Conclusion: This study provides a comprehensive overview of the safety of lebrikizumab and confirms that it has a favorable and manageable safety profile, supporting its suitability for long-term use in clinical practice.