Martorell-Calatayud A, Santos-Alarcón S, Sahuquillo-Torralba A, Rivera-Díaz R, Belinchón-Romero I, Ruiz-Genao D, Romero-Maté A, Ruiz-Villaverde R, Ferran-Farrés M, Gallardo-Hernández F, Almenara-Blasco M, Suarez-Perez J A, González-Cantero Á, Martínez-Lorenzo E, Fernández-Armenteros J M, Del Alcázar-Viladomiu E, García-Latasa J, Rocamora-Durant V, Ara-Martín M, Mateu-Puchades A, Llamas-Velasco M, Vilarrasa E, Velasco-Pastor M, De la Cueva P, Carrascosa J M, Magdaleno-Tapial J
Department of Dermatology, Hospital de Manises, Valencia, Spain.
Department of Dermatology, Hospital Virgen de los Lirios, Alcoy, Alicante, Spain.
Actas Dermosifiliogr. 2025 Feb;116(2):125-133. doi: 10.1016/j.ad.2024.02.030. Epub 2024 Mar 6.
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.
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.
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.
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/m). 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 ≤30kg/m 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.
Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.
司库奇尤单抗——一种靶向白细胞介素-23 p19亚基的人源化单克隆抗体——最近已被批准用于治疗中度至重度斑块状银屑病。目前缺乏基于具有代表性患者群体的真实世界数据。
评估司库奇尤单抗在常规临床实践中治疗中度至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，纳入了2020年4月至2022年11月连续接受司库奇尤单抗治疗的银屑病患者。主要终点是在第52周达到银屑病面积和严重程度指数（PASI）改善100%（PASI100）的患者数量。
共纳入510例患者，其中女性198例（38.8%），男性312例（61.2%）。平均年龄为51.7±14.4岁。共有227例（44.5%）研究参与者肥胖（体重指数[BMI]>30kg/m）。平均基线PASI评分为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PASI100。在第4周（P=0.04）、16周（P=0.001）和52周（P=0.002），BMI≤30kg/m组达到PASI≤2的患者数量更多。在初治组中，第16周和52周达到PASI100的患者数量在统计学上显著更多（分别为P=0.001）。在第16周，银屑病关节炎组达到PASI100的参与者数量显著更低（P=0.04）。在整个研究样本中，22例（4.3%）患者报告了某种类型的不良事件，20例（3.9%）患者停止治疗。
在常规临床实践中，司库奇尤单抗被证明是治疗中度至重度银屑病患者的一种安全有效的疗法。
