A Pharmacovigilance Analysis of Post-Marketing Safety of Tezepelumab.

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

To investigate the post-marketing safety of tezepelumab based on the US Food and Drug Administration Adverse Event Reporting System database.

METHODS

Adverse events (AEs) reported from January 2022 to December 2023 were extracted from the US Food and Drug Administration Adverse Event Reporting System database. Disproportionality analysis by reporting odds ratio and empirical Bayesian geometric mean was performed to detect potential AEs related to tezepelumab. We also assessed clinical characteristics and time to onset of AEs.

RESULTS

A total of 1,699 tezepelumab-related AE reports were identified during the study period. We detected 30 tezepelumab-related AE signals by simultaneously applying the two algorithms. At the system organ class level, the most common system organ class related to tezepelumab was respiratory, thoracic, and mediastinal disorders. At the preferred term 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. Median time to onset of tezepelumab-related AEs was 7.5 days and most AEs occurred within the first 1 month after tezepelumab initiation.

CONCLUSIONS

This 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.