Sicilian Regional Pharmacovigilance Center, University Hospital of Messina, Messina, Italy.
Department of Biomedical and Dental Sciences and Morpho-Functional Imaging, Section of Pharmacology, University of Messina, Messina, Italy.
Dermatol Ther. 2021 Mar;34(2):e14830. doi: 10.1111/dth.14830. Epub 2021 Feb 11.
The advent of Immune Checkpoint Inhibitors (ICIs) as a standard of care for several cancers, including melanoma and head/neck squamous cell carcinoma has changed the therapeutic approach to these conditions, drawing at the same time the attention on some safety issues related to their use. To assess the incidence of psoriasis as a specific immune-related cutaneous adverse event attributing to ICIs using the Eudravigilance reporting system. All reports of adverse drug reactions (ADRs) concerning either exacerbation of psoriasis or de novo onset of psoriasis/psoriasiform reactions associated to the use of Cytotoxic T-Lymphocyte Antigen-4 (CTLA-4) inhibitors ipilimumab and tremelimumab, and the Programmed cell Death protein 1/Programmed Death-Ligand 1 (PD-1/PD-L1) inhibitors nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, and cemiplimab were identified and extracted from the Eudravigilance reporting system, during the period between the date of market licensing (for each study drug) and 30 October 2020. 8213 reports of cutaneous ADRs associated with at least one of study drug have been recorded, of which 315 (3.8%) reporting psoriasis and/or psoriasiform reactions as ADR. In 70.8% of reports patients had pre-existing disease. ICIs-related skin toxicity is a well-established phenomenon, presenting with several conditions, sustained by an immune background based on the activity of some cells (CD4+/CD8+ T-cells, neutrophils, eosinophils, and plasmocytes), inflammatory mediators, chemokines, and tumor-specific antibodies. In this setting, psoriasis represents probably the most paradigmatic model of these reactions, thus requiring adequate recognition as no guidelines on management are now available.
免疫检查点抑制剂 (ICIs) 的出现作为几种癌症（包括黑色素瘤和头颈部鳞状细胞癌）的标准治疗方法，改变了这些疾病的治疗方法，同时也引起了人们对其使用相关的一些安全问题的关注。使用 Eudravigilance 报告系统评估作为特定免疫相关皮肤不良事件的银屑病的发生率归因于 ICI。与使用细胞毒性 T 淋巴细胞抗原 4 (CTLA-4) 抑制剂伊匹单抗和 tremelimumab 以及程序性细胞死亡蛋白 1/程序性死亡配体 1 (PD-1/PD-L1) 抑制剂 nivolumab、pembrolizumab、atezolizumab、durvalumab、avelumab 和 cemiplimab 相关的所有药物不良反应 (ADR) 报告，包括银屑病恶化或新发生银屑病/类银屑病反应，均从 Eudravigilance 报告系统中识别并提取出来，期间在市场许可日期（对于每种研究药物）和 2020 年 10 月 30 日之间。共记录了 8213 份与至少一种研究药物相关的皮肤 ADR 报告，其中 315 份（3.8%）报告了银屑病和/或类银屑病反应作为 ADR。在 70.8%的报告中，患者存在先前存在的疾病。ICI 相关的皮肤毒性是一种已确立的现象，表现为几种情况，其基础是基于一些细胞（CD4+/CD8+T 细胞、中性粒细胞、嗜酸性粒细胞和浆细胞）、炎症介质、趋化因子和肿瘤特异性抗体的免疫背景。在这种情况下，银屑病可能代表这些反应最典型的模型，因此需要充分认识，因为目前尚无管理指南。
