Assessment of safety profile of secukinumab in real-world scenario using United States food and drug administration adverse event reporting system database.

ABSTRACT: Secukinumab is an anti-IL-17 monoclonal antibody approved for treating psoriasis and various arthritides. A comprehensive evaluation of its safety, especially in a real-world setting, is necessary. This study aimed to describe the adverse events (AE) associated with secukinumab use using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. FAERS data files containing AE reports from 2015 to 2021 were downloaded for data mining. Primary or secondary suspect medications indicated for psoriasis were identified and analyzed. Medical dictionary for regulatory activities (MedDRA version 24.1) was used to analyze the AE terms. To detect potential safety signals of AE from secukinumab use, disproportionality analysis was used. A total of 365,590 adverse e

SUBMITTER: Eshwar V 

PROVIDER: S-EPMC10786882 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature