Real-world Safety and Efficacy of Risankizumab in Psoriatic Patients: A Multicenter, Retrospective, and Not-interventional Study.

IF 3.8 Q1 DERMATOLOGY

Actas dermo-sifiliograficas Pub Date : 2024-10-23 DOI:10.1016/j.ad.2024.10.042

A Martorell, S Santos-Alarcón, A Sahuquillo-Torralba, R Rivera-Díaz, I Belinchón-Romero, D Ruiz-Genao, A Romero-Maté, R Ruiz-Villaverde, M Ferrán-Farrés, F Gallardo-Hernández, M Almenara-Blasco, J Alonso-Suárez, Á González-Cantero, E Martínez-Lorenzo, J M Fernández-Armenteros, E de Alcázar-Viladomiu, J García-Latasa, V Rocamora-Durant, M Ara-Martín, A Mateu-Puchades, M Llamas-Velasco, E Vilarrasa-Rull, M Velasco-Pastor, P De la Cueva, J M Carrascosa, J Magdaleno-Tapial

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引用次数: 0

Abstract

Background and objective: risankizumab-a humanized monoclonal antibody that targets the p19 subunit of IL-23-has been recently approved to treat moderate-to-severe plaque psoriasis. Real-world data based on a representative pool of patients are currently lacking. Objective To assess the mid- and long-term safety and efficacy profile of risankizumab in patients with moderate-to-severe psoriasis in the routine clinical practice.

Methods: This was a retrospective and multicenter study of consecutive psoriatic patients on risankizumab from April 2020 through November 2022. The primary endpoint was the number of patients who achieved a 100% improvement in their Psoriasis Area and Severity Index (PASI) (PASI100) on week 52.

Results: A total of 510 patients, 198 (38.8%) women and 312 (61.2%) men were included in the study. The mean age was 51.7 ± 14.4 years. A total of 227 (44.5%) study participants were obese (body mass index [BMI] > 30kg/m²). The mean baseline PASI score was 11.4 ± 7.2, and the rate of patients who achieved PASI100 on week 52, 67.0%. Throughout the study follow-up, 21%, 50.0%, 59.0%, and 66% of the patients achieved PASI100 on weeks 4, 16, 24, and 40, respectively. The number of patients who achieved a PASI ≤ 2 was greater in the group with a BMI ≤ 30 kg/m² on weeks 4 (P = .04), 16 (P = .001), and 52 (P = .002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (P = .001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (P = .04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment.

Conclusions: Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.

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利桑珠单抗对银屑病患者的实际安全性和疗效：一项多中心、回顾性、非干预性研究

背景和目的：利桑珠单抗--一种靶向 IL-23 的 p19 亚基的人源化单克隆抗体--最近被批准用于治疗中重度斑块状银屑病。目前尚缺乏基于代表性患者的真实世界数据。目的在常规临床实践中评估利桑珠单抗对中重度银屑病患者的中长期安全性和疗效：这是一项回顾性多中心研究，研究对象为 2020 年 4 月至 2022 年 11 月期间连续使用利坦珠单抗的银屑病患者。主要终点是第52周银屑病面积和严重程度指数（PASI）（PASI100）改善100%的患者人数：研究共纳入了 510 名患者，其中女性 198 人（38.8%），男性 312 人（61.2%）。平均年龄为 51.7 ± 14.4 岁。共有 227 人（44.5%）为肥胖者（体重指数 [BMI] > 30kg/m2）。基线 PASI 平均得分为 11.4 ± 7.2，第 52 周达到 PASI100 的患者比例为 67.0%。在整个研究随访期间，分别有 21%、50.0%、59.0% 和 66% 的患者在第 4、16、24 和 40 周达到了 PASI100。在第 4 周（P = .04）、第 16 周（P = .001）和第 52 周（P = .002），体重指数≤ 30 kg/m2 组中达到 PASI ≤ 2 的患者人数更多。在第 16 周和第 52 周，未经治疗组达到 PASI100 的患者人数明显增加（分别为 0.001 和 0.002）。在第 16 周，银屑病关节病组达到 PASI100 的人数明显较少（P = .04）。在所有研究样本中，22 名（4.3%）患者报告了某种类型的不良事件，20 名（3.9%）患者中断了治疗：在常规临床实践中，利桑珠单抗对中重度银屑病患者是一种安全有效的治疗方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Actas dermo-sifiliograficas DERMATOLOGY-

CiteScore

1.90

自引率

9.40%

发文量

473

审稿时长

56 weeks

期刊介绍： Actas Dermo-Sifiliográficas, publicación Oficial de la Academia Española de Dermatología y Venereología, es una revista de prestigio consolidado. Creada en 1909, es la revista mensual más antigua editada en España.En 2006 entró en Medline, y hoy resulta imprescindible para estar al día sobre la dermatología española y mundial.