Caldarola Giacomo, Galluzzo Marco, Bernardini Nicoletta, Calabrese Laura, Grimaldi Marta, Moretta Gaia, Pagnanelli Gianluca, Shumak Ruslana Gaeta, Talamonti Marina, Tofani Lorenzo, Pallotta Sabatino, Peris Ketty, Potenza Concetta, De Simone Clara, Campione Elena
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):e15488. doi: 10.1111/dth.15488. Epub 2022 Apr 11.
New biologic agents targeting interleukin (IL)23/T-helper17 axis, such as tildrakizumab, have been developed for the treatment of plaque psoriasis. To analyze the efficacy and safety of tildrakizumab in a real life setting of patients affected by moderate-to-severe psoriasis over a 28-week treatment period. A multicentric retrospective study was conducted in patients who initiated tildrakizumab between February 2020 and March 2021. Psoriasis Area and Severity Index-PASI was measured at baseline and after 4, 16 and 28 weeks. The percentage change in PASI value from baseline to the considered time-points, proportion of patients with absolute PASI <3 at week 28 and the percentages of achieving a PASI75 or PASI90 response were assessed. Data about potential safety issues and adverse events (AEs) were collected. Statistical analysis were performed for establish clinical efficacy and for variables predicting clinical response. Fifty nine patients with psoriasis were included. Overall mean PASI percentage reduction was of 88% from baseline to week 28 and 47 out of 59 patients (79.7%) at week 28 had an absolute PASI <3. PASI75 and PASI90 responses at week 28 were achieved by 48 (81.40%) patients and 38 (64.4.0%) patients, respectively. No substantial associations between gender, body mass index - BMI, PASI at baseline and prior exposition to biological therapies and the efficacy endpoints were retrieved. No serious safety issues or discontinuations related to adverse events were reported. In our real-life study, tildrakizumab showed high efficacy and a favorable safety profile, regardless of patient- and disease-related factors.
已研发出新型生物制剂靶向白细胞介素（IL）-23/T辅助细胞17轴，如替拉珠单抗，用于治疗斑块状银屑病。为分析替拉珠单抗在中度至重度银屑病患者28周治疗期的实际应用中的疗效和安全性。对2020年2月至2021年3月开始使用替拉珠单抗的患者进行了一项多中心回顾性研究。在基线以及4周、16周和28周后测量银屑病面积和严重程度指数（PASI）。评估从基线到各时间点PASI值的百分比变化、第28周时绝对PASI<3的患者比例以及达到PASI75或PASI90缓解的患者百分比。收集有关潜在安全问题和不良事件（AE）的数据。进行统计分析以确定临床疗效和预测临床反应的变量。纳入了59例银屑病患者。从基线到第28周，PASI总体平均降低百分比为88%，59例患者中有47例（79.7%）在第28周时绝对PASI<3。第28周时，分别有48例（81.40%）患者和38例（64.40%）患者达到PASI75和PASI90缓解。未发现性别、体重指数（BMI）、基线PASI以及既往生物治疗暴露与疗效终点之间存在显著关联。未报告与不良事件相关的严重安全问题或停药情况。在我们的实际研究中，无论患者和疾病相关因素如何，替拉珠单抗均显示出高效和良好的安全性。
