Risk of Alopecia Areata Induced by Biologic Therapy in Psoriasis and Psoriatic Arthritis: A 20-Year Real-World Pharmacovigilance Analysis Using the FAERS Database
Description
The study investigates the potential adverse effect of alopecia areata (AA) in patients with psoriasis and psoriatic arthritis (PsA) undergoing biologic therapy. The research aims to evaluate the association and risk of AA with biologics using real-world data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from Q1 2004 to Q3 2024. The study conducted a disproportionality analysis, calculating the reporting odds ratio (ROR) to identify unusually high reporting frequencies of AA among patients treated with biologics. Key findings include: - A total of 108 reports of AA in the context of psoriasis or PsA treatment were retrieved, with 92 attributed to biologics. - The overall ROR of biologics was 2.12 (95% CI: 1.33–3.38), indicating a significant association. - Certain biologics showed significant associations with AA, including TNF-α inhibitors adalimumab (ROR = 1.65) and infliximab (ROR = 2.64), IL-23 inhibitor risankizumab (ROR = 2.30), and IL-12/23 inhibitor ustekinumab (ROR = 2.88). - Other biologics such as etanercept, ixekizumab, and secukinumab did not show significant RORs. The study emphasizes the need for clinicians to recognize AA as a potential adverse event associated with specific biologics and the importance of personalized treatment strategies to minimize the impact of paradoxical reactions. However, the study acknowledges several limitations, including the exclusion of some biologics due to low AA report numbers, potential biases in voluntary reporting to FAERS, and the inherent limitations of the ROR method, such as dependency on reported data and potential confounding factors.