a Dermatology, Department of "Medicina dei Sistemi" , University of Rome Tor Vergata , Rome , Italy.
b Institute of Dermatology , Catholic University of the Sacred Heart , Rome , Italy.
Expert Opin Biol Ther. 2018 Jul;18(7):727-735. doi: 10.1080/14712598.2018.1481503. Epub 2018 Jun 6.
To evaluate efficacy and safety of the anti-IL-17 drug secukinumab in a real-life large cohort of patients with moderate-to-severe plaque psoriasis in Central Italy.
Multicenter, retrospective study with an observation period of up to 52 weeks. Efficacy was assessed by Psoriasis Area and Severity Index (PASI) score; clinical and laboratory examinations were performed at baseline and at weeks 4, 12, 24, 36, and 52.
A 90% and a 100% PASI score reduction (PASI90 and PASI100) were reported in 67.5% and 55% of patients at week 12, respectively. A rapid improvement of skin lesions was observed particularly in young patients and in patients naïve to biologics: at week 4, the achievement of PASI90 and PASI100 was higher in younger patients (odds ratio [OR] 0.95, and 0.95; p = 0.003, and 0.005, respectively); PASI90 was achieved by 42.0% of patients naïve to biologics and by 17.0% of patients with prior exposure to biologics (PBT) (OR 0.24; p = 0.001); and PASI100 was reached by 25.5% of naïve patients and 9.8% of PBT (OR 0.28; p = 0.015).The drug was well tolerated.
Secukinumab was effective in this real-life analysis, with rapid clinical improvement and long-term maintenance of results.
评估抗 IL-17 药物司库奇尤单抗在意大利中部地区中度至重度斑块型银屑病大样本真实世界患者中的疗效和安全性。
多中心、回顾性研究,观察期最长达 52 周。采用银屑病面积和严重程度指数(PASI)评分评估疗效;在基线和第 4、12、24、36 和 52 周进行临床和实验室检查。
第 12 周时,分别有 67.5%和 55%的患者达到 PASI90 和 PASI100 缓解(PASI90 和 PASI100)。皮肤病变迅速改善,尤其在年轻患者和未接受过生物制剂治疗的患者中更为明显:第 4 周时,年轻患者达到 PASI90 和 PASI100 的比例更高(优势比[OR]分别为 0.95 和 0.95;p 值分别为 0.003 和 0.005);未接受过生物制剂治疗的患者中有 42.0%达到 PASI90 缓解,而有过生物制剂治疗史的患者中只有 17.0%达到(OR 0.24;p=0.001);未接受过生物制剂治疗的患者中有 25.5%达到 PASI100 缓解,而有过生物制剂治疗史的患者中只有 9.8%达到(OR 0.28;p=0.015)。药物耐受性良好。
在这项真实世界研究中,司库奇尤单抗疗效显著,临床改善迅速,疗效持久。