Shen Nonger, Fang Qingxia, Wu Yue, Lan Lan, Ma Fangfang
Center for Clinical Pharmacy, Cancer Center, Department of Pharmacy, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, Zhejiang, China.
Geriatric Medicine Center, Department of Nursing, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, Zhejiang, China.
PLoS One. 2025 Sep 8;20(9):e0332079. doi: 10.1371/journal.pone.0332079. eCollection 2025.
In recent years, with the expanding use of novel therapeutics such as immune checkpoint inhibitors and monoclonal antibodies, reports of drug-induced vitiligo have been increasing. This study aimed to identify drugs associated with vitiligo using the FDA Adverse Event Reporting System (FAERS).
A retrospective disproportionality analysis was performed on FAERS reports from the first quarter of 2004 to the fourth quarter of 2024. Disproportionality signals were assessed using the Reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN).
The present study identified 1,910 cases of vitiligo, with a median age of 54 years (interquartile range [IQR]: 40.0-66.0). The gender distribution among these cases was 45.9% female, 35.9% male, and 18.3% with undetermined gender. The three most frequently reported drugs were nivolumab (152 cases), pembrolizumab (132 cases), and dupilumab (77 cases). Forty-six drugs showed significant positive vitiligo signals. The three strongest signals (based on ROR) were mogamulizumab (ROR 73.93, 95% confidence interval [CI] 39.62-137.94; the lower 95% CI for the information component [IC025] 2.40), imiquimod (ROR 72.00, 95% CI 43.24-119.89; IC025 3.00) and chloroquine (ROR 53.33, 95% CI 17.13-166.02; IC025 0.47). Notably, 80.4% (37/46) of these drugs lacked vitiligo warnings in their FDA-approved labels.
This study has uncovered an extensive catalog of drugs with the potential to induce vitiligo. While these findings are based on pharmacovigilance signals and require further validation, patients receiving these medications should be closely monitored for the development of vitiligo.
近年来，随着免疫检查点抑制剂和单克隆抗体等新型疗法的使用不断增加，药物性白癜风的报告也在增多。本研究旨在利用美国食品药品监督管理局不良事件报告系统（FAERS）确定与白癜风相关的药物。
对2004年第一季度至2024年第四季度的FAERS报告进行回顾性不成比例分析。使用报告比值比（ROR）和贝叶斯置信传播神经网络（BCPNN）评估不成比例信号。
本研究共识别出1910例白癜风病例，中位年龄为54岁（四分位间距[IQR]：40.0 - 66.0）。这些病例的性别分布为女性45.9%，男性35.9%，性别未确定者18.3%。报告频率最高的三种药物为纳武单抗（152例）、帕博利珠单抗（132例）和度普利尤单抗（77例）。46种药物显示出显著的白癜风阳性信号。信号最强的三种药物（基于ROR）为莫格利珠单抗（ROR 73.93，95%置信区间[CI] 39.62 - 137.94；信息成分[IC025]的95%置信区间下限2.40）、咪喹莫特（ROR 72.00，95% CI 43.24 - 119.89；IC025 3.00）和氯喹（ROR 53.33，95% CI 17.13 - 166.02；IC025 0.47）。值得注意的是，这些药物中有80.4%（37/46）在其美国食品药品监督管理局批准的标签中没有白癜风警告。
本研究发现了大量具有诱发白癜风潜力的药物目录。虽然这些发现基于药物警戒信号且需要进一步验证，但接受这些药物治疗的患者应密切监测是否出现白癜风。
