Yang Yixuan, Xie Hanzhang, Li Dongtao, Jia Ying, Cui Bingnan, Zou Jianhua, Xiao Zhanshuo
Department of Dermatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5, Beixiange, Xicheng District, Beijing, 100053, China.
Beijing University of Chinese Medicine, Beijing, 100029, China.
Sci Rep. 2025 Jul 2;15(1):22733. doi: 10.1038/s41598-025-06314-0.
Vitiligo, a depigmentation disorder, significantly impacts the well-being of affected individuals. The induction of vitiligo by pharmacological agents is a critical concern, with prior research establishing a link between antineoplastic medications and the onset of vitiligo. This study aims to assess the reported association between vitiligo and antineoplastic drugs using the FAERS. The study encompassed FAERS reports spanning the years 2004 to 2024. Medical Dictionary for Regulatory Activities (MedDRA) was used to identify cases of vitiligo. The Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical Bayes Geometric Mean were calculated to assess the reported associations between available drugs and vitiligo. A significant statistical association was considered when a drug signal met the criteria of all four algorithms. Our analysis of the FAERS database revealed 533 adverse event (AE) reports implicating antineoplastic drugs in the development of vitiligo, with a higher prevalence among females compared to males. The 18-65 age group accounted for the majority of cases, with the United States contributing the most reports. Malignant melanoma was the most frequently reported underlying condition. Nivolumab and Pembrolizumab were the most commonly implicated drugs, with 147 and 126 reports, respectively. Disproportionality analysis identified 14 antineoplastic drugs with a significant association with vitiligo-related AEs, including the monoclonal antibody Mogamulizumab, immune checkpoint inhibitor Ipilimumab, and oncolytic virus Talimogene Laherparepvec, with Mogamulizumab exhibiting the highest correlation. These findings underscore the necessity for heightened clinical vigilance regarding the safety profiles of specific medications. This study represents the inaugural investigation into the real-world incidence of antineoplastic drug-induced vitiligo utilizing the FAERS database. Our findings reveal a strong association between vitiligo and immunomodulatory therapies, including immune checkpoint inhibitors and monoclonal antibodies. There is an imperative need for vigilant patient monitoring during the clinical administration of these agents to promptly identify and address potential AEs such as vitiligo.
白癜风是一种色素脱失性疾病，严重影响患者的身心健康。药物诱发白癜风是一个关键问题，先前的研究已证实抗肿瘤药物与白癜风的发病之间存在关联。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）评估所报道的白癜风与抗肿瘤药物之间的关联。该研究涵盖了2004年至2024年的FAERS报告。使用《医学监管活动医学词典》（MedDRA）来识别白癜风病例。计算报告比值比、比例报告比值比、贝叶斯置信传播神经网络和经验贝叶斯几何均值，以评估现有药物与白癜风之间所报道的关联。当药物信号符合所有四种算法的标准时，则认为存在显著的统计学关联。我们对FAERS数据库的分析显示，有533份不良事件（AE）报告表明抗肿瘤药物与白癜风的发生有关，女性的患病率高于男性。18 - 65岁年龄组的病例占大多数，美国的报告数量最多。恶性黑色素瘤是最常报告的基础疾病。纳武单抗和帕博利珠单抗是最常涉及的药物，分别有147份和126份报告。不成比例分析确定了14种与白癜风相关不良事件有显著关联的抗肿瘤药物，包括单克隆抗体莫格利珠单抗、免疫检查点抑制剂伊匹木单抗和溶瘤病毒talimogene laherparepvec，其中莫格利珠单抗的相关性最高。这些发现强调了提高对特定药物安全性概况临床警惕性的必要性。本研究是利用FAERS数据库对抗肿瘤药物诱发白癜风的真实世界发病率进行的首次调查。我们的研究结果揭示了白癜风与免疫调节疗法之间的紧密关联，包括免疫检查点抑制剂和单克隆抗体。在临床使用这些药物期间，迫切需要对患者进行密切监测，以便及时识别和处理诸如白癜风等潜在的不良事件。
