Disproportionality analysis of ixekizumab-associated adverse events in the FAERS database: A real-world pharmacovigilance study

Ixekizumab, a monoclonal antibody that neutralizes interleukin-17A, was approved by the Food and Drug Administration in 2016 for the treatment of plaque psoriasis and psoriatic arthritis. This study assesses the postmarketing safety profile of ixekizumab. Data from the Food and Drug Administration Adverse Event Reporting System were analyzed using disproportionate analysis methods, including the reporting odds ratio, the proportional reporting ratio, the Bayesian confidence propagation neural network, and the multi-item gamma Poisson shrinker algorithms. A total of 26,867 reports identified ixekizumab as the "primary suspected" drug. These ixekizumab-related adverse events (AEs) were observed across 27 targeted system organ classes. Notably, upon satisfying the criteria of all 4 algorithms, we identified 23,595 signals spanning 167 preferred terms. The most common signals were injection site reaction (broad), psoriasis, COVID-19, nasopharyngitis, urticaria, and sinusitis. New AEs identified include ear infections, tooth infections, necrotizing fasciitis, lichen planus, and pyoderma gangrenosum. The number of reports exhibited significant monthly fluctuations. There was a noticeable downward trend in reports each May, whereas December consistently showed an increase in reports. In recent report data, a trend of decrease has been observed starting from 2023. While our findings align with clinical trial results and the product label, our data revealed some new AEs. Noteworthy is the decline in reports starting from 2023.