Department of Education, National Taiwan University Hospital, Taipei, Taiwan.
Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan.
Expert Opin Drug Saf. 2020 Apr;19(4):395-402. doi: 10.1080/14740338.2020.1736034. Epub 2020 Mar 5.
: Risankizumab is a fully human monoclonal antibody that selectively targets interleukin (IL)-23A, interfering with the IL-23/17 axis that plays a crucial role in keratinocyte proliferation. In 2019, risankizumab was approved globally for the treatment of moderate-to-severe psoriasis.: The safety profile of risankizumab for the treatment of psoriasis is assessed in this review. A literature search was performed on 18 October 2019, and additional data from pooled safety analyses were evaluated.: Drugs blocking the IL-23 pathway are the most recently approved treatment for psoriasis, and risankizumab seems to be the most effective one among the three IL-23 blockers approved. Risankizumab was generally well tolerated in the clinical trials and was found to be relatively safe. The safety profile of risankizumab is generally similar in clinical trials compared to adalimumab and ustekinumab. In a subset of patients with latent tuberculosis, no active tuberculosis developed after risankizumab treatment for 55 weeks without tuberculosis prophylaxis. The combination of safety, efficacy and less frequent injection (every 12 weeks) make risankizumab an attractive new choice for individuals with moderate-to-severe psoriasis. However, the long-term impact of anti-drug antibodies (24%) observed in pivotal studies as well as safety concerns in those with viral infections, hepatitis, malignancies and those in endemic tuberculosis areas, await further studies.
里莎鲁单抗是一种全人源单克隆抗体，能选择性地靶向白细胞介素（IL）-23A，从而干扰起关键作用的 IL-23/17 轴，后者能促进角质形成细胞增殖。2019 年，里莎鲁单抗在全球范围内获批用于治疗中重度斑块状银屑病。
本综述评估了里莎鲁单抗治疗银屑病的安全性概况。检索日期为 2019 年 10 月 18 日，还评估了汇总安全性分析中的额外数据。
阻断 IL-23 通路的药物是最近获批用于治疗银屑病的药物，而里莎鲁单抗似乎是三种获批的 IL-23 抑制剂中最有效的一种。临床试验中，里莎鲁单抗总体耐受良好，且被认为相对安全。临床试验中，里莎鲁单抗的安全性概况与阿达木单抗和乌司奴单抗相似。在潜伏性结核病患者亚组中，55 周无结核病预防的情况下，接受里莎鲁单抗治疗后未发生活动性结核病。里莎鲁单抗具有安全性、疗效和较低注射频率（每 12 周 1 次）的优势，是中重度斑块状银屑病患者的一种有吸引力的新选择。但是，在关键性研究中观察到的抗药物抗体（24%）的长期影响以及在病毒感染、肝炎、恶性肿瘤和结核病流行地区患者中的安全性问题，仍有待进一步研究。
