Cheng Yuzhe, Ma Jingyi, Niu Jun
Department of Dermatology, General Hospital of Northern Theater Command, Shenyang, China.
Graduate School, China Medical University, Shenyang, China.
PLoS One. 2025 May 23;20(5):e0323973. doi: 10.1371/journal.pone.0323973. eCollection 2025.
Ixekizumab, a monoclonal antibody targeting IL-17A, is approved for psoriasis (PsO) and psoriatic arthritis (PsA). While clinical trials demonstrate its efficacy, real-world safety insights remain critical due to limitations in detecting rare or delayed adverse events (AEs).
This study analyzed 28,889 ixekizumab-associated AE reports from the first quarter of 2016 to the third quarter of 2024 in the FDA Adverse Event Reporting System (FAERS) using disproportionality methods (ROR, PRR, MGPS, BCPNN) and Weibull distribution modeling. Subgroup and sensitivity analyses were conducted to evaluate demographic variations and confounding factors.
Common AEs included injection site reaction, fungal infections, and upper respiratory infections. Novel signals included myocardial infarction, herpes zoster, and inflammatory bowel disease. Subgroup analyses revealed male-predominant cardiac risks and age-dependent patterns (pediatric injection reactions vs elderly herpes zoster). Median time-to-onset was 56 days (IQR:12-205), with early risk escalation (Weibull β = 0.60).
This FAERS analysis confirms ixekizumab's established safety profile while identifying critical demographic-specific and delayed-onset signals. Continuous pharmacovigilance is warranted to optimize risk management, particularly for cardiovascular monitoring in high-risk males and antiviral prophylaxis in elderly patients.
司库奇尤单抗是一种靶向白细胞介素-17A的单克隆抗体，已被批准用于治疗银屑病（PsO）和银屑病关节炎（PsA）。虽然临床试验证明了其疗效，但由于在检测罕见或延迟不良事件（AE）方面存在局限性，实际应用中的安全性见解仍然至关重要。
本研究使用不成比例法（ROR、PRR、MGPS、BCPNN）和威布尔分布模型，分析了2016年第一季度至2024年第三季度美国食品药品监督管理局不良事件报告系统（FAERS）中28889份与司库奇尤单抗相关的AE报告。进行了亚组分析和敏感性分析，以评估人口统计学差异和混杂因素。
常见的AE包括注射部位反应、真菌感染和上呼吸道感染。新发现的信号包括心肌梗死、带状疱疹和炎症性肠病。亚组分析揭示了男性为主的心脏风险和年龄依赖性模式（儿科注射反应与老年带状疱疹）。中位发病时间为56天（IQR：12-205），早期风险呈上升趋势（威布尔β=0.60）。
这项FAERS分析证实了司库奇尤单抗已有的安全性特征，同时识别出关键的人口统计学特异性和延迟发病信号。有必要持续进行药物警戒以优化风险管理，特别是对高危男性的心血管监测和老年患者的抗病毒预防。
