研究动态
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EudraVigilance中与白细胞介素-23抑制剂相关的疑似肿瘤性不良反应:比较研究及性别分布。

Suspected oncologic adverse reactions associated with interleukin-23 inhibitors in EudraVigilance: Comparative study and gender distribution.

发表日期:2023 Oct
作者: Fabrizio Calapai, Carmen Mannucci, Luigi Cardia, Mariaconcetta Currò, Gioacchino Calapai, Emanuela Esposito, Ilaria Ammendolia
来源: CYTOKINE & GROWTH FACTOR REVIEWS

摘要:

银屑病是一种以斑块形成为特征的慢性炎症性皮肤病。银屑病病变中白细胞介素(IL)-23的上调被认为是银屑病发病过程中Th17通路的主要调节因子。已经批准了三种针对IL-23p19亚基的单克隆抗体,分别是guselkumab、tildrakizumab和risankizumab,用于治疗银屑病。细胞因子IL-23和IL-12之间的平衡可能影响抗肿瘤和促肿瘤的免疫活性,而银屑病患者可能比一般人群更容易患癌症。此外,典型的银屑病慢性炎症状态可能诱导促肿瘤效应,但目前对于患者服用这些药物可能导致的恶性肿瘤风险了解甚少。本研究通过分析欧洲EudraVigilance数据库中的真实世界数据,调查了作为可能与IL-23抑制剂相关的疑似不良反应(SARs)发生的恶性肿瘤情况。尽管是推测性的,这些真实世界数据似乎证实了IL-23抑制剂risankizumab和tildrakizumab与银屑病患者中的癌症相关的SARs的潜在关联,并且从性别的角度来看,它们显示了这种关联在女性和男性之间是不对称分布的,男性中明显优势的癌症相关SARs。© 2023 The Authors. Pharmacology Research & Perspectives由英国药理学学会和美国药理学和实验治疗学会和约翰威利和儿子有限公司出版。
Psoriasis is a chronic inflammatory skin disease characterized by plaque formation. Interleukin (IL)-23 is upregulated in psoriatic lesions and is thought to be a major regulator of the Th17 pathway in psoriasis pathogenesis. Three monoclonal antibodies targeting the IL-23p19 subunit, guselkumab, tildrakizumab, and risankizumab, have been approved for psoriasis therapy. The balance between cytokines IL-23 and IL-12 can affect antitumor and pro-tumor immune activities, and patients with psoriasis may have higher rates of cancer than the general population. Moreover, a chronic inflammatory state typical of psoriasis may induce protumorigenic effects, however, the potential risk of malignancy in patients taking these drugs remains largely unknown. This study investigated the occurrence of malignancies as suspected adverse reactions (SARs) potentially associated with IL-23 inhibitors by analyzing real-world data from the European EudraVigilance database. Although indicatory, these real-world data seem to confirm the potential association between the IL-23 inhibitors risankizumab and tildrakizumab, and the occurrence of SARs linked to cancer in patients with psoriasis and, according to a gender perspective, they show that this relationship is asymmetrically distributed between women and men, with a clear prevalence of oncologic SARs in men.© 2023 The Authors. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd.