A pharmacovigilance analysis of post-marketing safety of tezepelumab.

Abstract

Background: Tezepelumab has shown promising efficacy for adult patients with severe asthma since its approval. However, the post-marketing safety evaluation of tezepelumab is currently lacking.

Objective: The present study aims to investigate the post-marketing safety of tezepelumab based on the FDA Adverse Event Reporting System (FAERS) database.

Methods: Adverse events (AEs) reports from January 2022 to December 2023 were extracted from the FAERS database. Disproportionality analysis by reporting odds ratio (ROR) and empirical Bayesian geometric mean (EBGM) was performed to detect potential AEs related to tezepelumab. Clinical characteristics and time to onset of AEs were also assessed.

Results: A total of 1,699 tezepelumab-related AE reports were identified during the study period. Thirty tezepelumab-related AE signals were detected by simultaneously applying the two algorithms. At the system organ class (SOC) level, the most common SOC related to tezepelumab was respiratory, thoracic and mediastinal disorders. At the preferred term (PT) level, common AEs including arthralgia and back pain were detected which were also documented in the label of tezepelumab and clinical trials. New unexpected AEs such as chest pain and myalgia were also identified. The median time to onset of tezepelumab-related AEs was 7.5 days, and the majority of AEs occurred within the first 1 month after tezepelumab initiation.

Conclusion: The present study presents a comprehensive evaluation of the post-marketing safety of tezepelumab in the real-world setting. Our findings will provide valuable evidence for future clinical studies and management of safety issues of tezepelumab.