Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome.
UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome.
Dermatol Ther. 2022 Jun;35(6):e15489. doi: 10.1111/dth.15489. Epub 2022 Apr 13.
Several new biologic agents targeting IL23/Th17 axis, such as risankizumab, have been developed for the treatment of psoriasis. The aim of the present study was to analyze the efficacy and safety of risankizumab in patients with moderate-to-severe psoriasis over a 52-week period. A multicentric retrospective study was conducted in patients who initiated risankizumab between July 2019 and December 2020. Psoriasis Area and Severity Index-PASI was measured at baseline and after 4, 16, 28 and 52 weeks. Clinical responses were evaluated by PASI75, PASI90 and PASI100 at the same timepoints. Potential safety issues and adverse events (AEs) were collected. Univariable and multivariable logistic regressions were performed for variables predicting clinical response. One hundred and twelve patients with psoriasis were included. PASI90 response was achieved by 17.86% of patients at week 4, 72.22% at week 16, 91.0% at week 28 and 95.24% at week 52 (as observed analysis). No associations between the considered variables and the efficacy endpoints were retrieved, influence of variables such as Body Mass Index (BMI), baseline PASI or previous biologics were not shown. No serious safety issues or discontinuations related to adverse events were reported. Risankizumab showed high efficacy and a favorable safety profile, regardless of patient- and disease-related factors.
几种针对 IL23/Th17 轴的新型生物制剂,如 risankizumab,已被开发用于治疗银屑病。本研究旨在分析 risankizumab 在中重度银屑病患者中 52 周的疗效和安全性。在 2019 年 7 月至 2020 年 12 月期间开始接受 risankizumab 治疗的患者中进行了一项多中心回顾性研究。在基线和第 4、16、28 和 52 周时测量银屑病面积和严重程度指数(PASI)。在相同时间点通过 PASI75、PASI90 和 PASI100 评估临床反应。收集了潜在的安全问题和不良反应(AE)。对预测临床反应的变量进行了单变量和多变量逻辑回归分析。共纳入 112 例银屑病患者。第 4 周时 17.86%的患者达到 PASI90 反应,第 16 周时 72.22%,第 28 周时 91.0%,第 52 周时 95.24%(观察分析)。未发现考虑的变量与疗效终点之间存在相关性,体重指数(BMI)、基线 PASI 或先前生物制剂等变量的影响并未显示。未报告与不良反应相关的严重安全问题或停药。无论患者和疾病相关因素如何,risankizumab 均显示出较高的疗效和良好的安全性。