Original article
Clinical Outcomes in Patients With Psoriasis Following Discontinuation of Efalizumab Due to Suspension of Marketing Authorization
Evolución clínica de los pacientes psoriásicos tratados con efalizumab al suspender el fármaco
O. Baniandrés
, A. Pulido, C. Silvente, R. Suárez, P. Lázaro
Autor para correspondencia
Servicio de Dermatología, Hospital General Universitario Gregorio Marañón, Madrid, Spain
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Experiencia en 7 casos" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "R.M. Martel, P. Melwani, D. Islas, Y. Peñate, L. Borrego" "autores" => array:5 [ 0 => array:2 [ "nombre" => "R.M." "apellidos" => "Martel" ] 1 => array:2 [ "nombre" => "P." "apellidos" => "Melwani" ] 2 => array:2 [ "nombre" => "D." "apellidos" => "Islas" ] 3 => array:2 [ "nombre" => "Y." "apellidos" => "Peñate" ] 4 => array:2 [ "nombre" => "L." "apellidos" => "Borrego" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1578219010706648?idApp=UINPBA000044" "url" => "/15782190/0000010100000005/v1_201304241523/S1578219010706648/v1_201304241523/en/main.assets" ] "en" => array:15 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Original article</span>" "titulo" => "Clinical Outcomes in Patients With Psoriasis Following Discontinuation of Efalizumab Due to Suspension of Marketing Authorization" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "421" "paginaFinal" => "427" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "O. Baniandrés, A. Pulido, C. Silvente, R. Suárez, P. Lázaro" "autores" => array:5 [ 0 => array:4 [ "nombre" => "O." "apellidos" => "Baniandrés" "email" => array:1 [ 0 => "ofelia_baniandres@yahoo.es" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">¿</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "A." "apellidos" => "Pulido" ] 2 => array:2 [ "nombre" => "C." "apellidos" => "Silvente" ] 3 => array:2 [ "nombre" => "R." "apellidos" => "Suárez" ] 4 => array:2 [ "nombre" => "P." "apellidos" => "Lázaro" ] ] "afiliaciones" => array:1 [ 0 => array:1 [ "entidad" => "Servicio de Dermatología, Hospital General Universitario Gregorio Marañón, Madrid, Spain" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Evolución clínica de los pacientes psoriásicos tratados con efalizumab al suspender el fármaco" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2009-09-07" "fechaAceptado" => "2009-12-16" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec84761" "palabras" => array:6 [ 0 => "Efalizumab" 1 => "Progressive multifocal leukoencephalopathy" 2 => "Psoriasis" 3 => "Rebound" 4 => "Relapse" 5 => "Treatment discontinuation" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec84760" "palabras" => array:6 [ 0 => "Efalizumab" 1 => "Leucoencefalopatía multifocal progresiva" 2 => "Psoriasis" 3 => "Rebote" 4 => "Recaída" 5 => "Suspensión" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span class="elsevierStyleSectionTitle">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">In February 2009, the European Medicines Agency suspended the marketing authorization for efalizumab after 3 confirmed cases of progressive multifocal leukoencephalopathy were reported. To assess the consequences of this decision, we performed a prospective follow-up study of patients in our department who were being treated with efalizumab at the time and compared clinical outcomes with data from the literature.</p> <span class="elsevierStyleSectionTitle">Patients and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Thirty-two patients (28 with plaque psoriasis and 4 with palmoplantar psoriasis) were enrolled between February and March 2009. We recorded psoriasis area and severity index (PASI) scores at the moment of efalizumab discontinuation, at 6 weeks post-discontinuation, and at 3-monthly intervals thereafter. PASI scores prior to treatment with efalizumab were also noted. For patients who experienced rebounds with generalized psoriasis, we noted the time that had elapsed since efalizumab discontinuation and the treatment they were receiving.</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Even though 92.8% of the patients were considered good responders (>75% reduction in PASI score), 25% of the group (8/32) experienced rebound and 15.7% (5/32) experienced relapse. The percentage of patients in whom rebound was observed on transition therapy was 18% (2/11) for cyclosporin, 50% (1/2) for methotrexate, 50% (1/2) for adalimumab, 50% (1/2) for etanercept, and 27% (3/11) for topical treatment.</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">We observed a very high rate of rebound and generalized inflammation in patients whose disease had previously been well controlled for several years.</p>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span class="elsevierStyleSectionTitle">Introducción</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">En febrero de 2009 la Agencia Europea de Evaluación de Medicamentos (EMEA) suspendió la comercialización de efalizumab por la notificación de tres casos confirmados de leucoencefalopatía multifocal progresiva (LMP). Nos planteamos realizar un estudio prospectivo de seguimiento de los pacientes tratados en nuestro Servicio con efalizumab en el momento de la suspensión y comparar la evolución con las perspectivas publicadas en la literatura.</p> <span class="elsevierStyleSectionTitle">Pacientes y métodos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 32 pacientes (28 con psoriasis en placas y 4 con psoriasis palmoplantar) entre febrero y marzo de 2009. Se recogió el Psoriasis Area and Severity Index (PASI) previo al comienzo del tratamiento con efalizumab, en el momento de la suspensión, a las 6 semanas y posteriormente cada tres meses. En el caso de los pacientes que presentaron brotes generalizados se recogió el tiempo transcurrido desde la suspensión y el manejo terapéutico que se realizó.</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">A pesar de que el 92,8% de los pacientes correspondían a buenos respondedores (mejoría PASI > 75), presentaron rebote un 25% de los sujetos (8/32) y recaídas un 15,7% (5/32). Con respecto a la terapia de transición presentaron rebote un 18% de los pacientes (2/11) con ciclosporina, un 50% (1/2) con metotrexato, un 50% (1/2) con adalimumab, un 50% (1/2) con etanercept y un 27% (3/11) de los que recibieron tratamiento tópico.</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Hemos encontrado un porcentaje muy alto de rebote y formas generalizadas inflamatorias en pacientes que habían conseguido un buen control de la psoriasis durante varios años.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:23 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "A novel targeted T-cell modulator, efalizumab, for plaque psoriasis" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "M. 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| año/Mes | Html | Total | |
|---|---|---|---|
| 2024 Noviembre | 10 | 14 | 24 |
| 2024 Octubre | 61 | 40 | 101 |
| 2024 Septiembre | 51 | 28 | 79 |
| 2024 Agosto | 93 | 53 | 146 |
| 2024 Julio | 57 | 39 | 96 |
| 2024 Junio | 68 | 40 | 108 |
| 2024 Mayo | 49 | 32 | 81 |
| 2024 Abril | 50 | 27 | 77 |
| 2024 Marzo | 46 | 34 | 80 |
| 2024 Febrero | 46 | 37 | 83 |
| 2024 Enero | 45 | 40 | 85 |
| 2023 Diciembre | 51 | 33 | 84 |
| 2023 Noviembre | 52 | 26 | 78 |
| 2023 Octubre | 44 | 33 | 77 |
| 2023 Septiembre | 54 | 26 | 80 |
| 2023 Agosto | 28 | 22 | 50 |
| 2023 Julio | 64 | 63 | 127 |
| 2023 Junio | 59 | 30 | 89 |
| 2023 Mayo | 45 | 25 | 70 |
| 2023 Abril | 31 | 34 | 65 |
| 2023 Marzo | 27 | 14 | 41 |
| 2023 Febrero | 23 | 18 | 41 |
| 2023 Enero | 27 | 27 | 54 |
| 2022 Diciembre | 33 | 44 | 77 |
| 2022 Noviembre | 15 | 23 | 38 |
| 2022 Octubre | 18 | 19 | 37 |
| 2022 Septiembre | 14 | 40 | 54 |
| 2022 Agosto | 17 | 42 | 59 |
| 2022 Julio | 15 | 34 | 49 |
| 2022 Junio | 14 | 27 | 41 |
| 2022 Mayo | 20 | 39 | 59 |
| 2022 Abril | 28 | 39 | 67 |
| 2022 Marzo | 26 | 58 | 84 |
| 2022 Febrero | 19 | 22 | 41 |
| 2022 Enero | 27 | 47 | 74 |
| 2021 Diciembre | 28 | 39 | 67 |
| 2021 Noviembre | 25 | 45 | 70 |
| 2021 Octubre | 24 | 59 | 83 |
| 2021 Septiembre | 28 | 48 | 76 |
| 2021 Agosto | 14 | 23 | 37 |
| 2021 Julio | 20 | 37 | 57 |
| 2021 Junio | 24 | 23 | 47 |
| 2021 Mayo | 23 | 33 | 56 |
| 2021 Abril | 40 | 48 | 88 |
| 2021 Marzo | 51 | 30 | 81 |
| 2021 Febrero | 41 | 26 | 67 |
| 2021 Enero | 22 | 13 | 35 |
| 2020 Diciembre | 20 | 17 | 37 |
| 2020 Noviembre | 28 | 21 | 49 |
| 2020 Octubre | 18 | 8 | 26 |
| 2020 Septiembre | 30 | 7 | 37 |
| 2020 Agosto | 21 | 33 | 54 |
| 2020 Julio | 13 | 8 | 21 |
| 2020 Junio | 21 | 22 | 43 |
| 2020 Mayo | 26 | 19 | 45 |
| 2020 Abril | 25 | 19 | 44 |
| 2020 Marzo | 25 | 20 | 45 |
| 2020 Febrero | 3 | 3 | 6 |
| 2020 Enero | 0 | 5 | 5 |
| 2019 Diciembre | 0 | 6 | 6 |
| 2019 Noviembre | 0 | 5 | 5 |
| 2019 Octubre | 0 | 3 | 3 |
| 2019 Agosto | 0 | 4 | 4 |
| 2019 Julio | 0 | 2 | 2 |
| 2019 Junio | 0 | 2 | 2 |
| 2019 Mayo | 1 | 36 | 37 |
| 2019 Abril | 0 | 2 | 2 |
| 2019 Marzo | 0 | 24 | 24 |
| 2019 Febrero | 0 | 3 | 3 |
| 2018 Marzo | 0 | 2 | 2 |
| 2018 Febrero | 12 | 2 | 14 |
| 2018 Enero | 16 | 5 | 21 |
| 2017 Diciembre | 12 | 6 | 18 |
| 2017 Noviembre | 14 | 5 | 19 |
| 2017 Octubre | 15 | 7 | 22 |
| 2017 Septiembre | 13 | 8 | 21 |
| 2017 Agosto | 16 | 7 | 23 |
| 2017 Julio | 15 | 0 | 15 |
| 2017 Junio | 39 | 5 | 44 |
| 2017 Mayo | 17 | 7 | 24 |
| 2017 Abril | 12 | 15 | 27 |
| 2017 Marzo | 17 | 8 | 25 |
| 2017 Febrero | 19 | 8 | 27 |
| 2017 Enero | 8 | 4 | 12 |
| 2016 Diciembre | 21 | 8 | 29 |
| 2016 Noviembre | 17 | 6 | 23 |
| 2016 Octubre | 21 | 5 | 26 |
| 2016 Septiembre | 31 | 8 | 39 |
| 2016 Agosto | 29 | 6 | 35 |
| 2016 Julio | 31 | 7 | 38 |
| 2016 Junio | 13 | 7 | 20 |
| 2016 Mayo | 9 | 7 | 16 |
| 2016 Abril | 3 | 1 | 4 |
| 2016 Marzo | 6 | 0 | 6 |
| 2016 Febrero | 5 | 2 | 7 |
| 2016 Enero | 9 | 5 | 14 |
| 2015 Diciembre | 8 | 1 | 9 |
| 2015 Noviembre | 7 | 0 | 7 |
| 2015 Octubre | 11 | 3 | 14 |
| 2015 Septiembre | 12 | 0 | 12 |
| 2015 Agosto | 20 | 3 | 23 |
| 2015 Julio | 38 | 4 | 42 |
| 2015 Junio | 25 | 9 | 34 |
| 2015 Mayo | 50 | 14 | 64 |
| 2015 Abril | 29 | 4 | 33 |
| 2015 Marzo | 27 | 7 | 34 |
| 2015 Febrero | 26 | 11 | 37 |
| 2015 Enero | 11 | 12 | 23 |
| 2014 Diciembre | 23 | 24 | 47 |
| 2014 Noviembre | 14 | 10 | 24 |
| 2014 Octubre | 21 | 16 | 37 |
| 2014 Septiembre | 16 | 11 | 27 |
| 2014 Agosto | 36 | 17 | 53 |
| 2014 Julio | 27 | 18 | 45 |
| 2014 Junio | 38 | 10 | 48 |
| 2014 Mayo | 33 | 10 | 43 |
| 2014 Abril | 38 | 6 | 44 |
| 2014 Marzo | 37 | 14 | 51 |
| 2014 Febrero | 26 | 12 | 38 |
| 2014 Enero | 31 | 16 | 47 |
| 2013 Diciembre | 31 | 9 | 40 |
| 2013 Noviembre | 27 | 12 | 39 |
| 2013 Octubre | 26 | 15 | 41 |
| 2013 Septiembre | 33 | 11 | 44 |
| 2013 Agosto | 15 | 24 | 39 |
| 2013 Julio | 30 | 52 | 82 |
| 2013 Junio | 20 | 27 | 47 |
| 2013 Mayo | 23 | 18 | 41 |
| 2013 Abril | 19 | 21 | 40 |
| 2013 Marzo | 20 | 18 | 38 |
| 2013 Febrero | 10 | 13 | 23 |
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