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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
Corresponding author
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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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 8 | 14 | 22 |
| 2024 October | 61 | 40 | 101 |
| 2024 September | 51 | 28 | 79 |
| 2024 August | 93 | 53 | 146 |
| 2024 July | 57 | 39 | 96 |
| 2024 June | 68 | 40 | 108 |
| 2024 May | 49 | 32 | 81 |
| 2024 April | 50 | 27 | 77 |
| 2024 March | 46 | 34 | 80 |
| 2024 February | 46 | 37 | 83 |
| 2024 January | 45 | 40 | 85 |
| 2023 December | 51 | 33 | 84 |
| 2023 November | 52 | 26 | 78 |
| 2023 October | 44 | 33 | 77 |
| 2023 September | 54 | 26 | 80 |
| 2023 August | 28 | 22 | 50 |
| 2023 July | 64 | 63 | 127 |
| 2023 June | 59 | 30 | 89 |
| 2023 May | 45 | 25 | 70 |
| 2023 April | 31 | 34 | 65 |
| 2023 March | 27 | 14 | 41 |
| 2023 February | 23 | 18 | 41 |
| 2023 January | 27 | 27 | 54 |
| 2022 December | 33 | 44 | 77 |
| 2022 November | 15 | 23 | 38 |
| 2022 October | 18 | 19 | 37 |
| 2022 September | 14 | 40 | 54 |
| 2022 August | 17 | 42 | 59 |
| 2022 July | 15 | 34 | 49 |
| 2022 June | 14 | 27 | 41 |
| 2022 May | 20 | 39 | 59 |
| 2022 April | 28 | 39 | 67 |
| 2022 March | 26 | 58 | 84 |
| 2022 February | 19 | 22 | 41 |
| 2022 January | 27 | 47 | 74 |
| 2021 December | 28 | 39 | 67 |
| 2021 November | 25 | 45 | 70 |
| 2021 October | 24 | 59 | 83 |
| 2021 September | 28 | 48 | 76 |
| 2021 August | 14 | 23 | 37 |
| 2021 July | 20 | 37 | 57 |
| 2021 June | 24 | 23 | 47 |
| 2021 May | 23 | 33 | 56 |
| 2021 April | 40 | 48 | 88 |
| 2021 March | 51 | 30 | 81 |
| 2021 February | 41 | 26 | 67 |
| 2021 January | 22 | 13 | 35 |
| 2020 December | 20 | 17 | 37 |
| 2020 November | 28 | 21 | 49 |
| 2020 October | 18 | 8 | 26 |
| 2020 September | 30 | 7 | 37 |
| 2020 August | 21 | 33 | 54 |
| 2020 July | 13 | 8 | 21 |
| 2020 June | 21 | 22 | 43 |
| 2020 May | 26 | 19 | 45 |
| 2020 April | 25 | 19 | 44 |
| 2020 March | 25 | 20 | 45 |
| 2020 February | 3 | 3 | 6 |
| 2020 January | 0 | 5 | 5 |
| 2019 December | 0 | 6 | 6 |
| 2019 November | 0 | 5 | 5 |
| 2019 October | 0 | 3 | 3 |
| 2019 August | 0 | 4 | 4 |
| 2019 July | 0 | 2 | 2 |
| 2019 June | 0 | 2 | 2 |
| 2019 May | 1 | 36 | 37 |
| 2019 April | 0 | 2 | 2 |
| 2019 March | 0 | 24 | 24 |
| 2019 February | 0 | 3 | 3 |
| 2018 March | 0 | 2 | 2 |
| 2018 February | 12 | 2 | 14 |
| 2018 January | 16 | 5 | 21 |
| 2017 December | 12 | 6 | 18 |
| 2017 November | 14 | 5 | 19 |
| 2017 October | 15 | 7 | 22 |
| 2017 September | 13 | 8 | 21 |
| 2017 August | 16 | 7 | 23 |
| 2017 July | 15 | 0 | 15 |
| 2017 June | 39 | 5 | 44 |
| 2017 May | 17 | 7 | 24 |
| 2017 April | 12 | 15 | 27 |
| 2017 March | 17 | 8 | 25 |
| 2017 February | 19 | 8 | 27 |
| 2017 January | 8 | 4 | 12 |
| 2016 December | 21 | 8 | 29 |
| 2016 November | 17 | 6 | 23 |
| 2016 October | 21 | 5 | 26 |
| 2016 September | 31 | 8 | 39 |
| 2016 August | 29 | 6 | 35 |
| 2016 July | 31 | 7 | 38 |
| 2016 June | 13 | 7 | 20 |
| 2016 May | 9 | 7 | 16 |
| 2016 April | 3 | 1 | 4 |
| 2016 March | 6 | 0 | 6 |
| 2016 February | 5 | 2 | 7 |
| 2016 January | 9 | 5 | 14 |
| 2015 December | 8 | 1 | 9 |
| 2015 November | 7 | 0 | 7 |
| 2015 October | 11 | 3 | 14 |
| 2015 September | 12 | 0 | 12 |
| 2015 August | 20 | 3 | 23 |
| 2015 July | 38 | 4 | 42 |
| 2015 June | 25 | 9 | 34 |
| 2015 May | 50 | 14 | 64 |
| 2015 April | 29 | 4 | 33 |
| 2015 March | 27 | 7 | 34 |
| 2015 February | 26 | 11 | 37 |
| 2015 January | 11 | 12 | 23 |
| 2014 December | 23 | 24 | 47 |
| 2014 November | 14 | 10 | 24 |
| 2014 October | 21 | 16 | 37 |
| 2014 September | 16 | 11 | 27 |
| 2014 August | 36 | 17 | 53 |
| 2014 July | 27 | 18 | 45 |
| 2014 June | 38 | 10 | 48 |
| 2014 May | 33 | 10 | 43 |
| 2014 April | 38 | 6 | 44 |
| 2014 March | 37 | 14 | 51 |
| 2014 February | 26 | 12 | 38 |
| 2014 January | 31 | 16 | 47 |
| 2013 December | 31 | 9 | 40 |
| 2013 November | 27 | 12 | 39 |
| 2013 October | 26 | 15 | 41 |
| 2013 September | 33 | 11 | 44 |
| 2013 August | 15 | 24 | 39 |
| 2013 July | 30 | 52 | 82 |
| 2013 June | 20 | 27 | 47 |
| 2013 May | 23 | 18 | 41 |
| 2013 April | 19 | 21 | 40 |
| 2013 March | 20 | 18 | 38 |
| 2013 February | 10 | 13 | 23 |
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