Abstract 16751: Novel Psoriasis Agents Associated Cardiotoxicity: Analysis of FAERS

Introduction: Psoriasis is a chronic skin condition characterised by hyper-proliferation of epidermal keratinocytes, resulting in erythematous and scaling lesions. The US Food and Drug Administration (FDA) has approved nine biological agents to address the burden of psoriasis, but their cardiovascular risks remain poorly studied.

Methods: This retrospective pharmacovigilance study utilised the FDA Adverse Event Reporting System database to analyse adverse events associated with newly approved therapeutic agents for psoriasis. We employed disproportionally signal analysis, calculating the reporting odds ratio (ROR) with a 95% confidence interval.

Results: Among the vast FAERS database, which contained more than 25 million adverse events, a total of 334,399 events were associated with newly approved therapeutic agents for psoriasis. Cardiac adverse events accounted for 3,852 cases, including pericarditis, atrial fibrillation, and coronary artery disease. Secukinumab had the highest number of reported adverse events, followed by brodalumab, while tildrakizumab had the lowest. Coronary artery disease was the most reported adverse event (1,438 cases), followed by pericarditis (572 cases) and atrial fibrillation (384 cases). Secukinumab had the highest incidence of coronary artery disease, pericarditis, and atrial fibrillation. Risankizumab showed a significant association with an increased risk of coronary artery disease and atrial fibrillation, while tildrakizumab and Ixekizumab were associated with atrial fibrillation. Secukinumab was associated with an elevated risk of pericarditis.

Conclusions: The study uncovers unknown cardiovascular adverse effects related to biologic agents used in psoriasis treatment. These findings emphasise the importance of monitoring and evaluating the cardiovascular safety profiles of biologic agents used in psoriasis treatment.