Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2020 Aug;80(12):1235-1245. doi: 10.1007/s40265-020-01357-1.
Risankizumab (Skyrizi; risankizumab-rzaa) is a humanized immunoglobulin (Ig) G1 monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23, thereby inhibiting IL-23-dependent cell signaling. Subcutaneous risankizumab is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy (in the EU), those who are candidates for systemic therapy or phototherapy (in the USA) and those who have an inadequate response to conventional therapies (in Japan). In pivotal phase III trials (UltIMMa-1, UltIMMa-2, IMMvent and IMMhance), risankizumab was more effective than placebo, ustekinumab and adalimumab with regard to the proportion of patients achieving ≥ 90% improvement from baseline in Psoriasis Area and Severity Index score (PASI 90) and a static Physician's Global Assessment score of 0 or 1 at week 16, with these benefits maintained over the longer term. In supportive head-to-head trials, risankizumab was also superior to secukinumab and fumaric acid esters in terms of PASI 90 response rate. In an ongoing open-label extension study (LIMMitless), risankizumab was associated with durable and improved efficacy after switching from ustekinumab or adalimumab, as well as durable maintenance of efficacy through > 2.5 years of continuous exposure. Treatment with risankizumab improved health-related quality of life and was generally well tolerated, both in the short- and longer-term. In conclusion, risankizumab represents a useful new treatment option for patients with moderate to severe plaque psoriasis.
里莎鲁单抗（Skyrizi；里莎鲁单抗-rzaa）是一种人源化 IgG1 单克隆抗体，特异性靶向白细胞介素（IL）-23 的 p19 亚单位，从而抑制 IL-23 依赖性细胞信号转导。皮下注射用里莎鲁单抗已获批准用于治疗适合全身治疗（在欧盟）、适合全身治疗或光疗（在美国）以及对常规治疗反应不足（在日本）的中度至重度斑块型银屑病成人患者。在关键性 III 期试验（UltIMMa-1、UltIMMa-2、IMMVent 和 IMMhance）中，与安慰剂、乌司奴单抗和阿达木单抗相比，里莎鲁单抗在第 16 周时达到从基线 Psoriasis Area and Severity Index 评分（PASI 90）改善≥90%和静态医师整体评估评分 0 或 1 的患者比例方面更有效，并且这些益处长期维持。在支持性头对头试验中，与司库奇尤单抗和富马酸酯类药物相比，里莎鲁单抗在 PASI 90 应答率方面也具有优势。在一项正在进行的开放性扩展研究（LIMMitless）中，与乌司奴单抗或阿达木单抗转换后，里莎鲁单抗具有持久和改善的疗效，并且在超过 2.5 年的连续暴露后持续保持疗效。里莎鲁单抗治疗改善了健康相关生活质量，并且在短期和长期均具有良好的耐受性。总之，里莎鲁单抗为中度至重度斑块型银屑病患者提供了一种有用的新治疗选择。
