A. Martorell-Calatayud , S. Santos-Alarcón , A. Sahuquillo-Torralba , R. Rivera-Díaz , I. Belinchón-Romero , D. Ruiz-Genao , A. Romero-Maté , R. Ruiz-Villaverde , M. Ferran-Farrés , F. Gallardo-Hernández , M. Almenara-Blasco , J.A. Suarez-Perez , Á. González-Cantero , E. Martínez-Lorenzo , J.M. Fernández-Armenteros , E. del Alcázar-Viladomiu , J. García-Latasa , V. Rocamora-Durant , M. Ara-Martín , A. Mateu-Puchades , J. Magdaleno-Tapial
{"title":"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","authors":"A. Martorell-Calatayud , S. Santos-Alarcón , A. Sahuquillo-Torralba , R. Rivera-Díaz , I. Belinchón-Romero , D. Ruiz-Genao , A. Romero-Maté , R. Ruiz-Villaverde , M. Ferran-Farrés , F. Gallardo-Hernández , M. Almenara-Blasco , J.A. Suarez-Perez , Á. González-Cantero , E. Martínez-Lorenzo , J.M. Fernández-Armenteros , E. del Alcázar-Viladomiu , J. García-Latasa , V. Rocamora-Durant , M. Ara-Martín , A. Mateu-Puchades , J. Magdaleno-Tapial","doi":"10.1016/j.ad.2024.10.042","DOIUrl":null,"url":null,"abstract":"<div><h3>Background and objective</h3><div>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.</div></div><div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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] >30<!--> <!-->kg/m<sup>2</sup>). 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/m<sup>2</sup> on weeks 4 (<em>P</em> <!-->=<!--> <!-->.04), 16 (<em>P</em> <!-->=<!--> <!-->.001), and 52 (<em>P</em> <!-->=<!--> <!-->.002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (<em>P</em> <!-->=<!--> <!-->.001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (<em>P</em> <!-->=<!--> <!-->.04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment.</div></div><div><h3>Conclusions</h3><div>Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.</div></div>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"116 2","pages":"Pages T125-T133"},"PeriodicalIF":3.8000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Artículo traducido] Eficacia y seguridad del risankizumab en pacientes con psoriasis en el mundo real: un estudio retrospectivo, multicéntrico y no intervencionista\",\"authors\":\"A. Martorell-Calatayud , S. Santos-Alarcón , A. Sahuquillo-Torralba , R. Rivera-Díaz , I. Belinchón-Romero , D. Ruiz-Genao , A. Romero-Maté , R. Ruiz-Villaverde , M. Ferran-Farrés , F. Gallardo-Hernández , M. Almenara-Blasco , J.A. Suarez-Perez , Á. González-Cantero , E. Martínez-Lorenzo , J.M. Fernández-Armenteros , E. del Alcázar-Viladomiu , J. García-Latasa , V. Rocamora-Durant , M. Ara-Martín , A. Mateu-Puchades , J. Magdaleno-Tapial\",\"doi\":\"10.1016/j.ad.2024.10.042\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background and objective</h3><div>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.</div></div><div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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] >30<!--> <!-->kg/m<sup>2</sup>). 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/m<sup>2</sup> on weeks 4 (<em>P</em> <!-->=<!--> <!-->.04), 16 (<em>P</em> <!-->=<!--> <!-->.001), and 52 (<em>P</em> <!-->=<!--> <!-->.002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (<em>P</em> <!-->=<!--> <!-->.001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (<em>P</em> <!-->=<!--> <!-->.04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment.</div></div><div><h3>Conclusions</h3><div>Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.</div></div>\",\"PeriodicalId\":7173,\"journal\":{\"name\":\"Actas dermo-sifiliograficas\",\"volume\":\"116 2\",\"pages\":\"Pages T125-T133\"},\"PeriodicalIF\":3.8000,\"publicationDate\":\"2025-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Actas dermo-sifiliograficas\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0001731024008548\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Actas dermo-sifiliograficas","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0001731024008548","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
[Artículo traducido] Eficacia y seguridad del risankizumab en pacientes con psoriasis en el mundo real: un estudio retrospectivo, multicéntrico y no intervencionista
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] >30 kg/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.
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.
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