批准的生物制剂靶向白细胞介素(IL)-23p19用于治疗中重度斑块状银屑病,包括guselkumab,tildrakizumab,和risankizumab,通常具有良好的安全性。本综述的目的是详细描述这些选择性抑制剂的安全性。从成立到2022年11月1日,使用PubMed进行了文献检索,以使用关键词“guselkumab,\"\"tildrakizumab,\"和\"risankizumab。“总的来说,临床试验中与IL-23p19抑制剂相关的最常见不良事件(AE)是鼻咽炎,头痛,上呼吸道感染.严重不良事件和感兴趣不良事件的比率,包括严重的感染,非黑色素瘤皮肤癌(NMSC),不包括NMSC的恶性肿瘤,主要不良心血管事件,和严重的超敏反应,在临床试验中长期使用并没有增加。选择性靶向IL-23p19也与机会性感染的风险升高无关。结核病再激活,口腔念珠菌病,或者炎症性肠病.现实世界研究的结果相似,支持在更广泛的银屑病患者中安全长期使用这些生物制剂,包括老年患者,多种生物制剂失败的患者,以及那些有肥胖等合并症的人,代谢综合征,心血管疾病,血脂异常,糖尿病,高血压,和银屑病关节炎.由于研究设计和安全性数据报告方法之间的差异,因此缺乏治疗药物之间的直接比较,因此该综述受到限制。总之,IL-23p19抑制剂的良好安全性支持其长期用于中重度银屑病患者的治疗.
The approved biologics targeting interleukin (IL)-23 p19 for the treatment of moderate-to-severe plaque psoriasis, including guselkumab, tildrakizumab, and risankizumab, have generally favorable safety profiles. The aim of the current
review is to describe in detail the safety of these selective inhibitors. A literature search was performed using PubMed from inception to 1 November 2022, to identify clinical trials and real-world evidence publications using the keywords \"guselkumab,\" \"tildrakizumab,\" and \"risankizumab.\" Overall, the most common adverse events (AEs) associated with IL-23 p19 inhibitors in clinical trials were nasopharyngitis, headache, and upper respiratory tract infections. Rates of serious AEs and AEs of interest, including serious infections, nonmelanoma skin cancer (NMSC), malignancies excluding NMSC, major adverse cardiovascular events, and serious hypersensitivity reactions, were not increased with long-term use in clinical trials. Selectively targeting IL-23 p19 was also not associated with elevated risk of opportunistic infections, tuberculosis reactivation, oral candidiasis, or inflammatory bowel disease. Results from real-world studies were similar, supporting the safe long-term use of these biologics in a wider population of patients with psoriasis, including older patients, patients for whom multiple biologics failed, and those with comorbidities such as obesity, metabolic syndrome, cardiovascular disease, dyslipidemia, diabetes, hypertension, and psoriatic arthritis. This
review is limited by the lack of direct comparisons among therapeutic agents due to differences among study designs and safety data reporting methods. In conclusion, the favorable safety profiles of IL-23 p19 inhibitors support their long-term use in the management of patients with moderate-to-severe psoriasis.