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替拉珠单抗:西班牙安达卢西亚地区三家三级医院的中期(52周)疗效、安全性及生存率研究

Tildrakizumab: Efficacy, Safety and Survival in Mid-Term (52 Weeks) in Three Tertiary Hospitals in Andalucia (Spain).

作者信息

Ruiz-Villaverde Ricardo, Rodriguez Fernandez-Freire Lourdes, Font-Ugalde Pilar, Galan-Gutierrez Manuel

机构信息

Department of Dermatology, Servicio de Dermatología, Hospital Universitario San Cecilio, Avenida de la Investigación s/n, 18016 Granada, Spain.

Spain Biohealth Research Institute in Granada (ibs.GRANADA), 18012 Granada, Spain.

出版信息

J Clin Med. 2022 Aug 30;11(17):5098. doi: 10.3390/jcm11175098.

DOI:10.3390/jcm11175098
PMID:36079026
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9456674/
Abstract

Tildrakizumab (TIL) binds selectively to the p19 subunit of interleukin 23. Its introduction has managed to increase the levels of efficacy, safety (improving that previously presented by the anti-IL-12/23 class) and survival. Retrospective analysis of a multicenter, observational study of real clinical practice including patients with moderate-to-severe plaque psoriasis in treatment with TIL. This cross-sectional analysis includes information of patients between February 2019 to February 2022. A total of three tertiary hospitals in Andalusia (Spain) participated in this study. Analyses were performed "as observed" using IBM SPSS v28 for Windows. A total of 61 patients were included in the analysis. The mean age of our patients was 49.5 years; 50.18% of the patients were female and 34.42% of the patients had a BMI greater than 30. It was notable that 44.26% of our patients had scalp involvement. Almost 35% of the patients had psoriatic arthropathy, although skin involvement was predominant. At week 52 (n = 34), 68% of the patients presented an absolute PASI equal to or less than 1. Regarding the drug survival, eight patients discontinued treatment due to inefficacy: five primary and three secondary failures, and one death due to causes not drug related showing survival of 86% at week 52. In the analysis of subgroups of patients, we found that scalp involvement determined greater survival (94%), as well as a shorter duration of the disease (91.7% vs. 84.4% in those with less than 10 years versus more than 15 years of evolution) and with a lower number of previous biological therapies (100% naïve, 90% in those who have used one line of biological therapy and 82.1% in those who have completed two or more lines of biological treatment. Tildrakizumab showed excellent results in the control of psoriasis in the mid-term with an elevated number of patients maintaining treatment after 52 weeks. There were no statistically significant differences in the efficiency, safety or survival results of TIL between patients coming from previous therapies.

摘要

替拉珠单抗(TIL)选择性结合白细胞介素23的p19亚基。它的引入提高了疗效水平、安全性(改善了先前抗IL-12/23类药物的安全性)以及生存率。对一项多中心、观察性真实临床实践研究进行回顾性分析,该研究纳入了接受TIL治疗的中度至重度斑块状银屑病患者。这项横断面分析纳入了2019年2月至2022年2月期间患者的信息。西班牙安达卢西亚的三家三级医院参与了本研究。使用适用于Windows的IBM SPSS v28进行“观察性”分析。分析共纳入61例患者。我们患者的平均年龄为49.5岁;50.18%的患者为女性,34.42%的患者BMI大于30。值得注意的是,44.26%的患者有头皮受累。近35%的患者患有银屑病关节炎,尽管以皮肤受累为主。在第52周时(n = 34),68%的患者绝对银屑病面积和严重程度指数(PASI)等于或小于1。关于药物生存率,8例患者因无效而停药:5例原发性和3例继发性失败,1例因与药物无关的原因死亡,在第52周时生存率为86%。在患者亚组分析中,我们发现头皮受累患者的生存率更高(94%),疾病持续时间更短(病程小于10年的患者为91.7%,病程超过15年的患者为84.4%),且既往生物治疗次数更少(初治患者为100%,使用过一线生物治疗的患者为90%,完成过两线或更多线生物治疗的患者为82.1%)。替拉珠单抗在中期银屑病控制方面显示出优异结果,52周后维持治疗的患者数量增加。既往接受过不同治疗的患者在替拉珠单抗的疗效、安全性或生存结果方面无统计学显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e08/9456674/34c155e6f4e4/jcm-11-05098-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e08/9456674/34c155e6f4e4/jcm-11-05098-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e08/9456674/34c155e6f4e4/jcm-11-05098-g001.jpg

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Use of biologics during the COVID-19 pandemic: lessons learned from psoriasis.2019冠状病毒病大流行期间生物制剂的使用:从银屑病中吸取的经验教训。
Expert Opin Biol Ther. 2022 Dec;22(12):1521-1529. doi: 10.1080/14712598.2022.2110467. Epub 2022 Aug 8.
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