Vitiligo is a common depigmenting disorder ensuing the loss of epidermal melanocytes. It is a multifactorial disease with immunological, genetic and environmental factors including drug exposure. The purpose of the study was to investigate the drugs and therapeutic subclasses associated with vitiligo occurrence reported in VigiBase^®, the WHO pharmacovigilance database. A case/non‐case study was carried out by defining cases as vitiligo reports and non‐cases as all other reports. The reporting odds ratio (ROR) was calculated for the ‘suspected’ drugs and drug classes according to ATC level 4. During the study period, 741 cases of vitiligo were registered. Mean age was 49 ± 20 years. The disproportionality analysis showed an association between vitiligo and pembrolizumab (ROR 116.9, 95% Confidence Interval (CI) 94.8, 144.3), nivolumab (ROR 22.6, 95% CI 15.8, 32.4), ipilimumab (ROR 41.7, 95% CI 25.0, 69.7), imiquimod (ROR 152.8, 95% CI 103.0, 226.7), adalimumab (ROR 3.8, 95% CI 2.5,5.8), infliximab (ROR 2.6, 95% CI 1.65, 4.01), alemtuzumab (ROR 27.8, 95% CI 17.6, 43.9), and ustekinumab (ROR 9.3, 95% CI 5.6, 15.6). Concerning the pharmacological classes ATC level 4, a significant association was found with monoclonal antibodies, interferons, selective immunosuppressants, TNF‐alpha inhibitors, interleukin inhibitors, and topical antivirals. This study confirmed the expected associations between vitiligo and immune checkpoint inhibitors and strengthened the emerging signal about the association between vitiligo and imiquimod, TNF‐alpha inhibitors and interferons. New signals were shown with selective immunosuppressants including alemtuzumab and interleukin inhibitors.

中文翻译：

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药物诱发的白癜风：世卫组织药物警戒数据库Vigibase®中的病例/非病例研究。

白癜风是导致表皮黑素细胞丢失的常见脱色素障碍。它是一种多因素疾病，具有免疫，遗传和环境因素，包括药物接触。这项研究的目的是调查与VigiBase报道白癜风的发生有关的药物和治疗亚^®，WHO药物警戒数据库。通过将案例定义为白癜风报告，将非案例定义为所有其他报告来进​​行案例/非案例研究。根据ATC 4级，针对“可疑”药物和药物类别计算了报告比值比（ROR）。在研究期间，登记了741例白癜风病例。平均年龄为49±20岁。比例失调分析显示白癜风和派姆单抗（ROR 116.9，95％置信区间（CI）94.8，144.3），nivolumab（ROR 22.6，95％CI 15.8，32.4），伊匹单抗（ROR 41.7，95％CI 25.0，69.7）之间存在关联），咪喹莫特（ROR 152.8、95％CI 103.0、226.7），阿达木单抗（ROR 3.8、95％CI 2.5、5.8），英夫利昔单抗（ROR 2.6、95％CI 1.65、4.01），阿仑单抗（ROR 27.8、95％CI 17.6） ，43.9）和乌斯他单抗（ROR 9.3，95％CI 5.6，15.6）。关于ATC的药理等级4，发现与单克隆抗体，干扰素，选择性免疫抑制剂，TNF-α抑制剂，白介素抑制剂和局部抗病毒药物之间存在显着关联。这项研究证实了白癜风和免疫检查点抑制剂之间的预期联系，并加强了有关白癜风与咪喹莫特，TNF-α抑制剂和干扰素之间联系的新信号。选择性免疫抑制剂包括alemtuzumab和白介素抑制剂显示出新信号。这项研究证实了白癜风和免疫检查点抑制剂之间的预期联系，并加强了有关白癜风与咪喹莫特，TNF-α抑制剂和干扰素之间联系的新信号。选择性免疫抑制剂包括alemtuzumab和白介素抑制剂显示出新信号。这项研究证实了白癜风和免疫检查点抑制剂之间的预期联系，并加强了有关白癜风与咪喹莫特，TNF-α抑制剂和干扰素之间联系的新信号。选择性免疫抑制剂包括alemtuzumab和白介素抑制剂显示出新信号。