A pharmacovigilance analysis of post-marketing safety of tezepelumab

Published online November 7, 2024

Tezepelumab has shown promising efficacy for adult patients with severe asthma without phenotypic or biomarker restrictions since its approval. However, the post-marketing safety evaluation of tezepelumab is currently lacking.

In research published in The Journal of Allergy and Clinical Immunology: In Practice, Li et al. extracted adverse events (AEs) reports from January 2022 to December 2023 from the FDA Adverse Event Reporting System (FAERS) database and conducted a disproportionality analysis to detect potential AEs related to tezepelumab. The time to onset of AEs was also assessed.

During the study period, Li et al. identified 1,699 tezepelumab-related AE reports from the FAERS database, among which 64 tezepelumab-related AE signals across 15 system organ classes (SOCs) were detected. The most common SOC related to tezepelumab was respiratory, thoracic and mediastinal disorders, followed by musculoskeletal and connective tissue disorders and general disorders and administration site conditions. Common labeled AEs including arthralgia and back pain were confirmed, and new unexpected AEs such as chest pain and myalgia were also identified. In addition, the median time to onset of tezepelumab-related AEs was 7.5 days, and most AEs occurred within the first month after tezepelumab initiation. These findings will provide clinicians and readers with valuable information for therapy decisions, early detection, and prompt management of tezepelumab related AEs to promote the rational use of tezepelumab in clinical practice.

The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.

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