Abrouk M, Gandy J, Nakamura M, Lee K, Brodsky M, Singh R, Zhu H, Farahnik B, Bhutani T, Koo J
Irvine School of Medicine, University of California, CA, USA.
Department of Dermatology, Psoriasis and Skin Treatment Center, University of California - San Francisco, San Francisco, CA, USA.
Skin Therapy Lett. 2017 Jul;22(4):1-6.
While there are several commercially available treatment options for psoriasis and psoriatic arthritis, there remains a large number of individuals who are refractory to current modalities. In the recent past, there has been increasing evidence that interleukin (IL)-17 plays a vital role in the pathophysiology of psoriasis. Preclinical, phase II, and phase III studies of secukinumab (Cosentyx®) targeting IL-17 and its receptor have thus far proved to be promising. We reviewed the results of phase II and phase III clinical trials for secukinumab in the treatment of psoriasis and psoriatic arthritis. Only published studies were considered in the present review. We also performed an English language literature search from January 2003 to September 2015 using PubMed with any of the following key words: (secukinumab OR AIN457) AND (psoriasis OR psoriatic arthritis). In our review of the literature, seven phase III and five phase II clinical trials, as well as open-label extension studies with unpublished findings were found. Results from phase III clinical trials indicated secukinumab to be efficacious and safe for the treatment of psoriasis and psoriatic arthritis according to Psoriasis Area and Severity Index (PASI) and American College of Rheumatology (ACR) scores. The safety profile of this agent was similar across all studies, with the most frequently reported adverse events of nasopharyngitis, upper respiratory infections, headache, and injection site reaction. Secukinumab demonstrates rapid and robust clinical improvement accompanied by a favorable short- term safety profile. The results of the phase III trials continue to reinforce the theory that the IL-17 pathway is an essential target in psoriasis and psoriatic arthritis treatment. Additional extension studies of lower level evidence are needed to further understand the safety profile of the drug.
虽然有几种用于治疗银屑病和银屑病关节炎的商业可用治疗方案,但仍有大量个体对当前治疗方式无效。最近,越来越多的证据表明白细胞介素(IL)-17在银屑病的病理生理学中起着至关重要的作用。迄今为止,针对IL-17及其受体的司库奇尤单抗(可善挺®)的临床前、II期和III期研究已证明颇具前景。我们回顾了司库奇尤单抗治疗银屑病和银屑病关节炎的II期和III期临床试验结果。本综述仅考虑已发表的研究。我们还使用PubMed对2003年1月至2015年9月的英文文献进行了检索,关键词为:(司库奇尤单抗或AIN457)以及(银屑病或银屑病关节炎)。在我们的文献综述中,发现了7项III期和5项II期临床试验,以及未发表结果的开放标签扩展研究。III期临床试验结果表明,根据银屑病面积和严重程度指数(PASI)以及美国风湿病学会(ACR)评分,司库奇尤单抗治疗银屑病和银屑病关节炎有效且安全。在所有研究中,该药物的安全性概况相似,最常报告的不良事件为鼻咽炎、上呼吸道感染、头痛和注射部位反应。司库奇尤单抗显示出快速且显著的临床改善,同时具有良好的短期安全性概况。III期试验结果继续强化了IL-17通路是银屑病和银屑病关节炎治疗中重要靶点的理论。需要更多低级别证据的扩展研究来进一步了解该药物的安全性概况。