Risk of Alopecia Areata Induced by Biologic Therapy in Psoriasis and Psoriatic Arthritis: A 20-Year Real-World Pharmacovigilance Analysis Using the FAERS Database

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.

本研究旨在探讨患有银屑病及其关节炎（PsA）的患者在接受生物治疗过程中，斑秃（AA）可能产生的潜在不良影响。研究旨在通过分析美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库中2004年第一季度至2024年第三季度的真实世界数据，评估AA与生物制剂之间的关联及风险。研究通过进行差异分析，计算报告优势比（ROR），以识别接受生物制剂治疗的患者中AA报告频率异常高的现象。

主要发现包括：
- 在银屑病或PsA治疗背景下，共检索到108例AA报告，其中92例归因于生物制剂。
- 生物制剂的整体ROR为2.12（95% CI：1.33–3.38），表明存在显著关联。
- 某些生物制剂与AA表现出显著的关联，包括TNF-α抑制剂阿达木单抗（ROR = 1.65）和英夫利昔单抗（ROR = 2.64），IL-23抑制剂瑞沙珠单抗（ROR = 2.30），以及IL-12/23抑制剂乌司奴单抗（ROR = 2.88）。
- 其他生物制剂如依那西普、依克西单抗和司库奇单抗并未显示出显著的ROR。

研究强调，临床医生应将AA视为与特定生物制剂相关的一种潜在不良事件，并重视个性化治疗策略，以降低矛盾反应的影响。然而，研究也承认了若干局限，包括因AA报告数量低而排除某些生物制剂，自愿向FAERS报告可能存在的偏差，以及ROR方法固有的局限性，例如依赖于报告数据以及潜在的混杂因素。