Original Article
[]Eficacia y seguridad del risankizumab en pacientes con psoriasis en el mundo real: un estudio retrospectivo, multicéntrico y no intervencionista
Real-world Safety and Efficacy of Risankizumab in Psoriatic Patients: A Multicenter, Retrospective, and Not-interventional Study
A. Martorell1,
, S. Santos-Alarcón2, A. Sahuquillo-Torralba3, R. Rivera-Díaz4, I. Belinchón-Romero5, D. Ruiz-Genao6, A. Romero-Maté7, R. Ruiz-Villaverde8, M. Ferrán-Farrés9, F. Gallardo-Hernández9, M. Almenara-Blasco10, J. Alonso-Suárez11, Á. González-Cantero12, E. Martínez-Lorenzo13, JM. Fernández-Armenteros14, E. de Alcázar-Viladomiu15, J. García-Latasa16, V. Rocamora-Durant17, M. Ara-Martín18, A. Mateu-Puchades19..., M. Llamas-Velasco20, E. Vilarrasa-Rull21, M. Velasco-Pastor22, P. De la Cueva23, JM. Carrascosa24, J. Magdaleno-Tapial25Ver más
Autor para correspondencia
1 Department of Dermatology, Hospital de Manises, Valencia, Spain
2 Department of Dermatology, Hospital Virgen de los Lirios, Alcoy, Spain
3 Department of Dermatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain
4 Department of Dermatology, Hospital Universitario 12 de Octubre, Madrid, Spain
5 Department of Dermatology, Hospital General Universitario de Alicante, Spain
6 Department of Dermatology, Hospital Universitario de Alcorcón, Madrid, Spain
7 Department of Dermatology, Hospital Universitario de Fuenlabrada, Madrid, Spain
8 Department of Dermatology, Hospital Universitario PTS, Granada, Spain
9 Department of Dermatology, Hospital del Mar, Barcelona, Spain
10 Department of Dermatology, Hospital Universitario Miguel Servet, Zaragoza, Spain
11 Department of Dermatology, Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain
12 Department of Dermatology, Hospital Universitario Ramón y Cajal, Madrid, Spain
13 Department of Dermatology, Hospital Universitario de Toledo, Spain
14 Department of Dermatology, Hospital Arnau de Vilanova de Lleida, Barcelona, Spain
15 Department of Dermatology, Hospital Universitario Trias i Pujol, Barcelona, Spain
16 Department of Dermatology, Hospital Royo Villanova, Zaragoza, Spain
17 Department of Dermatology, Hospital de Manacor, Mallorca, Spain
18 Department of Dermatology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain
19 Department of Dermatology, Hospital Universitario Doctor Peset, Valencia, Spain
20 Department of Dermatology, Hospital de la Princesa, Madrid, Spain
21 Department of Dermatology, Hospital Sant Pau, Barcelona, Spain
22 Department of Dermatology, Arnau de Vilanova, Valencia, Spain
23 Department of Dermatology, Hospital Universitario Infanta Leonor, Madrid, Spain
24 Department of Dermatology Hospital Universitari Germans Trias i Pujol (HUGiT), Spain
25 Department of Dermatology, Hospital General Universitario de Valencia, Valencia, Spain
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y Cajal, Madrid, Spain" "etiqueta" => "12" "identificador" => "aff0060" ] 12 => array:3 [ "entidad" => "Department of Dermatology, Hospital Universitario de Toledo, Spain" "etiqueta" => "13" "identificador" => "aff0065" ] 13 => array:3 [ "entidad" => "Department of Dermatology, Hospital Arnau de Vilanova de Lleida, Barcelona, Spain" "etiqueta" => "14" "identificador" => "aff0070" ] 14 => array:3 [ "entidad" => "Department of Dermatology, Hospital Universitario Trias i Pujol, Barcelona, Spain" "etiqueta" => "15" "identificador" => "aff0075" ] 15 => array:3 [ "entidad" => "Department of Dermatology, Hospital Royo Villanova, Zaragoza, Spain" "etiqueta" => "16" "identificador" => "aff0080" ] 16 => array:3 [ "entidad" => "Department of Dermatology, Hospital de Manacor, Mallorca, Spain" "etiqueta" => "17" "identificador" => "aff0085" ] 17 => array:3 [ "entidad" => "Department of Dermatology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain" "etiqueta" => "18" "identificador" => "aff0090" ] 18 => array:3 [ "entidad" => "Department of Dermatology, Hospital Universitario Doctor Peset, Valencia, Spain" "etiqueta" => "19" "identificador" => "aff0095" ] 19 => array:3 [ "entidad" => "Department of Dermatology, Hospital de la Princesa, Madrid, Spain" "etiqueta" => "20" "identificador" => "aff0100" ] 20 => array:3 [ "entidad" => "Department of Dermatology, Hospital Sant Pau, Barcelona, Spain" "etiqueta" => "21" "identificador" => "aff0105" ] 21 => array:3 [ "entidad" => "Department of Dermatology, Arnau de Vilanova, Valencia, Spain" "etiqueta" => "22" "identificador" => "aff0110" ] 22 => array:3 [ "entidad" => "Department of Dermatology, Hospital Universitario Infanta Leonor, Madrid, Spain" "etiqueta" => "23" "identificador" => "aff0115" ] 23 => array:3 [ "entidad" => "Department of Dermatology Hospital Universitari Germans Trias i Pujol (HUGiT), Spain" "etiqueta" => "24" "identificador" => "aff0120" ] 24 => array:3 [ "entidad" => "Department of Dermatology, Hospital General Universitario de Valencia, Valencia, Spain" "etiqueta" => "25" "identificador" => "aff0125" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author" ] ] ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Real-world Safety and Efficacy of Risankizumab in Psoriatic Patients: A Multicenter, Retrospective, and Not-interventional Study" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2024-01-25" "fechaAceptado" => "2024-02-24" "PalabrasClave" => array:2 [ "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1897791" "palabras" => array:5 [ 0 => "Psoriasis" 1 => "Risankizumab" 2 => "Datos del mundo real" 3 => "anticuerpo monoclonal" 4 => "Índice de Área y Severidad de la Psoriasis (PASI)" ] ] ] "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1897792" "palabras" => array:5 [ 0 => "Psoriasis" 1 => "Risankizumab" 2 => "Real-world data" 3 => "Monoclonal antibody" 4 => "Psoriasis Area and Severity Index (PASI)" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Antecedentes: Risankizumab es un anticuerpo monoclonal humanizado que se dirige a la subunidad p19 de IL-23, recientemente aprobado para el tratamiento de la psoriasis en placas moderada a grave. Actualmente falta datos del mundo real basados en una muestra representativa de pacientes.</p><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Objetivo: Evaluar la eficacia y seguridad a medio y largo plazo del risankizumab en pacientes con psoriasis moderada a grave en la práctica clínica habitual.</p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Métodos: Estudio retrospectivo y multicéntrico realizado en pacientes consecutivos con psoriasis que recibieron tratamiento con risankizumab desde abril de 2020 hasta noviembre de 2022. El criterio de valoración principal fue la proporción de pacientes que alcanzaron una mejora en el Índice de Área y Severidad de la Psoriasis (PASI) del 100% (PASI100) en la semana 52.</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Resultados: Se incluyeron en el estudio un total de 510 pacientes, 198 (38.8%) mujeres y 312 (61.2%) hombres. La edad media fue de 51.7±14.4 años y 227 (44.5%) sujetos eran obesos (índice de masa corporal [IMC]>30kg/m2). La puntuación media del PASI basal fue de 11.4±7.2. La proporción de pacientes que alcanzaron PASI100 en la semana 52 fue del 67.0%. A lo largo del seguimiento del estudio, el 21%, 50.0%, 59.0% y 66% de los pacientes alcanzaron un PASI 100 en la semana 4, semana 16, semana 24 y semana 40, respectivamente. La proporción de pacientes que alcanzaron un PASI≤2 fue mayor en el grupo con un IMC≤30 kg/m2 en la semana 4 (p=0.04), semana 16 (p=0.001) y semana 52 (p=0.002). Una proporción estadísticamente significativa mayor de pacientes alcanzó un PASI100 en el grupo sin tratamiento previo en la semana 16 y semana 52 (p=0.001 en cada una, respectivamente). En la semana 16, una proporción significativamente menor de sujetos alcanzó un PASI100 en el grupo con artropatía psoriásica (p=0.04). Entre la muestra total del estudio, 22 (4.3%) pacientes reportaron algún tipo de evento adverso y 20 (3.9%) abandonaron o se retiraron del tratamiento.</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Conclusiones: Risankizumab fue un tratamiento efectivo y seguro para pacientes con psoriasis moderada a grave en la práctica clínica.</p></span>" ] "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">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.</p><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Objective</p><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">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.</p><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">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.</p><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">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/m<span class="elsevierStyleSup">2</span>). 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<span class="elsevierStyleSup">2</span> on weeks 4 (<span class="elsevierStyleItalic">P</span> = .04), 16 (<span class="elsevierStyleItalic">P</span> = .001), and 52 (<span class="elsevierStyleItalic">P</span> = .002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (<span class="elsevierStyleItalic">P</span> = .001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (<span class="elsevierStyleItalic">P</span> = .04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment.</p><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Conclusions: Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.</p></span>" ] ] ] "idiomaDefecto" => "es" "url" => "/00017310/unassign/S0001731024008548/v1_202410240442/es/main.assets" "Apartado" => null "PDF" => "https://static.elsevier.es/multimedia/00017310/unassign/S0001731024008548/v1_202410240442/es/main.pdf?idApp=UINPBA000044&text.app=https://actasdermo.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0001731024008548?idApp=UINPBA000044" ]
| año/Mes | Html | Total | |
|---|---|---|---|
| 2024 Octubre | 25 | 42 | 67 |
