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"apellidos" => "Santos-Juanesc" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1578219011708198?idApp=UINPBA000044" "url" => "/15782190/0000010200000005/v1_201304241545/S1578219011708198/v1_201304241545/en/main.assets" ] "itemAnterior" => array:18 [ "pii" => "S1578219011708174" "issn" => "15782190" "doi" => "10.1016/S1578-2190(11)70817-4" "estado" => "S300" "fechaPublicacion" => "2011-06-01" "aid" => "70817" "copyright" => "Academia Española de Dermatología y Venereología and Elsevier España, S.L." 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"apellidos" => "Jordá" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1578219011708174?idApp=UINPBA000044" "url" => "/15782190/0000010200000005/v1_201304241545/S1578219011708174/v1_201304241545/en/main.assets" ] "en" => array:15 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Original Article</span>" "titulo" => "Clinical Characteristics and Disease Course in Patients Treated With Efalizumab Following Suspension of Marketing Authorization by the European Medicines Agency: A Multicenter Observational Study" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "354" "paginaFinal" => "364" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "L. Morell, J.M. Carrascosa, C. Ferrándiz, M. García-Bustinduy, E. Fonseca, G. Carretero, E. Daudén, S.E. Marrón, J.L. López-Estebaranz, M. Ferrán, M. Sánchez-Regaña, C. Muñoz-Santos, I. Belinchón, Luis Puig" "autores" => array:15 [ 0 => array:4 [ "nombre" => "L." "apellidos" => "Morell" "email" => array:1 [ 0 => "laiamorell@hotmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "J.M." "apellidos" => "Carrascosa" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 2 => array:3 [ "nombre" => "C." "apellidos" => "Ferrándiz" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 3 => array:3 [ "nombre" => "M." 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"apellidos" => "López-Estebaranz" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">g</span>" "identificador" => "aff0035" ] ] ] 9 => array:3 [ "nombre" => "M." "apellidos" => "Ferrán" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">h</span>" "identificador" => "aff0040" ] ] ] 10 => array:3 [ "nombre" => "M." "apellidos" => "Sánchez-Regaña" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">i</span>" "identificador" => "aff0045" ] ] ] 11 => array:3 [ "nombre" => "C." "apellidos" => "Muñoz-Santos" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">j</span>" "identificador" => "aff0050" ] ] ] 12 => array:3 [ "nombre" => "I." "apellidos" => "Belinchón" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">k</span>" "identificador" => "aff0055" ] ] ] 13 => array:3 [ "nombre" => "Luis" "apellidos" => "Puig" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">l</span>" "identificador" => "aff0060" ] ] ] 14 => array:1 [ "colaborador" => "on behalf of the Spanish Psoriasis Group" ] ] "afiliaciones" => array:12 [ 0 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain" "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Universitario de Canarias, Islas Canarias, Spain" "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Juan Canalejo, La Coruña, Spain" "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Universitario de Canarias Dr. Negrín, Islas Canarias, Spain" "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Universitario de la Princesa, Madrid, Spain" "etiqueta" => "<span class="elsevierStyleSup">e</span>" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital de Calatayud, Instituto Aragonés de Ciencias de la Salud, Zaragoza, Spain" "etiqueta" => "<span class="elsevierStyleSup">f</span>" "identificador" => "aff0030" ] 6 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital de Alcorcón, Madrid, Spain" "etiqueta" => "<span class="elsevierStyleSup">g</span>" "identificador" => "aff0035" ] 7 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital del Mar, Barcelona, Spain" "etiqueta" => "<span class="elsevierStyleSup">h</span>" "identificador" => "aff0040" ] 8 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital del Sagrat Cor, Barcelona, Spain" "etiqueta" => "<span class="elsevierStyleSup">i</span>" "identificador" => "aff0045" ] 9 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Clínic i Provincial, Barcelona, Spain" "etiqueta" => "<span class="elsevierStyleSup">j</span>" "identificador" => "aff0050" ] 10 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital General de Alicante, Alicante, Spain" "etiqueta" => "<span class="elsevierStyleSup">k</span>" "identificador" => "aff0055" ] 11 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain" "etiqueta" => "<span class="elsevierStyleSup">l</span>" "identificador" => "aff0060" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "*" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Perfil clínico y curso evolutivo de los pacientes tratados con efalizumab tras la suspensión de su autorización por la EMEA. Estudio observacional y multicéntrico" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2010-10-22" "fechaAceptado" => "2010-12-20" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec84921" "palabras" => array:4 [ 0 => "Efalizumab" 1 => "European Medicines Agency" 2 => "Rebound" 3 => "Generalized inflammatory flare" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec84920" "palabras" => array:4 [ 0 => "Efalizumab" 1 => "EMEA" 2 => "Rebote" 3 => "Exacerbación inflamatoria generalizada" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span class="elsevierStyleSectionTitle">Background and objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The withdrawal of marketing authorization for efalizumab by the European Medicines Agency in February, 2009 provided a unique opportunity to assess the course of disease in patients who were not subject to the selection criteria and biases that were common in the pivotal trials. The aim of this study was to evaluate the course of psoriasis following forced suspension of efalizumab in a group of patients treated in normal clinical practice. As secondary objectives, we sought to assess the relationships between clinical characteristics, treatment response, and disease course during efalizumab treatment and 12 and 24 weeks after suspension.</p> <span class="elsevierStyleSectionTitle">Patients and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Information on the epidemiological profile and disease course during treatment and following suspension of the drug was collected from a group of patients treated with efalizumab. Statistical analyses were performed to identify predictive factors.</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">One hundred forty-seven patients from 12 Spanish hospitals were included in the study. During treatment, 4% of patients were diagnosed with generalized inflammatory flares. Most patients could be classified as having a good (55%) or moderate (18%) response to treatment. Rebound following withdrawal of efalizumab was observed in 30% of patients. The likelihood of rebound was independent of clinical characteristics, treatment response, or therapeutic approach used by the dermatologist following suspension.</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">There was a high frequency of rebound following suspension of efalizumab, exceeding the rate reported in pivotal trials. This is particularly noteworthy given the large proportion of patients with a good response to treatment and therefore believed to have a better prognosis. Other significant findings were the higher frequency of positive treatment response than observed in previous studies (possibly influenced by the mean treatment duration) and the high frequency of generalized inflammatory flares.</p>" ] "es" => array:1 [ "resumen" => "<span class="elsevierStyleSectionTitle">Introducción</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">La reciente resolución de la EMEA con respecto a la suspensión de efalizumab, ocurrida en febrero del año 2009, ha proporcionado una oportunidad única para comprobar la evolución de un grupo de pacientes en cuya selección no intervinieron los filtros ni los sesgos habituales de los estudios pivotales. El objetivo planteado fue evaluar el curso de la psoriasis tras la suspensión forzosa de efalizumab en un grupo de pacientes tratados en el ámbito clínico. Como objetivos secundarios se planteó investigar su perfil clínico, la respuesta y evolución durante el tratamiento y el curso evolutivo a las 12 y 24 semanas tras la suspensión.</p> <span class="elsevierStyleSectionTitle">Pacientes y métodos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se recogió información procedente de un grupo de pacientes tratados con efalizumab referida al perfil epidemiológico, al curso de la dermatosis durante el tratamiento y a su evolución al suspenderlo. Se llevaron a cabo estudios estadísticos con vistas a identificar variables predictivas de los distintos objetivos investigados.</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 147 pacientes procedentes de 12 centros hospitalarios nacionales. Durante el tratamiento un 4% de los pacientes fue diagnosticado de exacerbación inflamatoria generalizada. La mayor parte de los pacientes pudieron ser clasificados como buenos respondedores (55%) o respondedores moderados (18%). Un 30% de los pacientes presentaron rebote tras la suspensión de efalizumab. La probabilidad de rebote fue independiente del perfil clínico, la respuesta al tratamiento o la actitud terapéutica del dermatólogo al suspenderlo.</p> <span class="elsevierStyleSectionTitle">Discusión y conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Se comprobó una elevada ocurrencia de fenómeno de rebote tras la suspensión de efalizumab, superior a la descrita en los ensayos clínicos pivotales y especialmente significativa si se tiene en cuenta la elevada incidencia de buenos respondedores durante el tratamiento, considerados de mejor pronóstico. Otros datos significativos son la superior perspectiva de respuesta clínica –presumiblemente condicionada por el tiempo medio de tratamiento–, y la elevada incidencia de episodios de exacerbación inflamatoria generalizada.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:29 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1." "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Clinical experience acquired with the efalizumab (Raptiva®) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: results from a phase III international randomized, placebo-controlled trial" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "L. Dubertret" 1 => "W. Sterry" 2 => "J.D. Bos" 3 => "S. Chimenti" 4 => "S. Shumack" 5 => "C.G. 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2024 October | 53 | 44 | 97 |
2024 September | 53 | 31 | 84 |
2024 August | 71 | 49 | 120 |
2024 July | 57 | 34 | 91 |
2024 June | 47 | 25 | 72 |
2024 May | 53 | 28 | 81 |
2024 April | 63 | 31 | 94 |
2024 March | 56 | 34 | 90 |
2024 February | 46 | 34 | 80 |
2024 January | 34 | 39 | 73 |
2023 December | 46 | 33 | 79 |
2023 November | 48 | 42 | 90 |
2023 October | 42 | 28 | 70 |
2023 September | 49 | 29 | 78 |
2023 August | 37 | 27 | 64 |
2023 July | 50 | 66 | 116 |
2023 June | 58 | 28 | 86 |
2023 May | 35 | 28 | 63 |
2023 April | 24 | 18 | 42 |
2023 March | 27 | 24 | 51 |
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2022 October | 15 | 26 | 41 |
2022 September | 16 | 43 | 59 |
2022 August | 17 | 30 | 47 |
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2021 September | 30 | 52 | 82 |
2021 August | 14 | 37 | 51 |
2021 July | 15 | 34 | 49 |
2021 June | 10 | 33 | 43 |
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2021 April | 18 | 58 | 76 |
2021 March | 29 | 29 | 58 |
2021 February | 39 | 29 | 68 |
2021 January | 20 | 14 | 34 |
2020 December | 25 | 12 | 37 |
2020 November | 12 | 17 | 29 |
2020 October | 26 | 11 | 37 |
2020 September | 32 | 11 | 43 |
2020 August | 26 | 24 | 50 |
2020 July | 8 | 13 | 21 |
2020 June | 12 | 23 | 35 |
2020 May | 35 | 18 | 53 |
2020 April | 14 | 16 | 30 |
2020 March | 29 | 26 | 55 |
2020 February | 5 | 3 | 8 |
2020 January | 0 | 2 | 2 |
2019 December | 0 | 8 | 8 |
2019 November | 0 | 1 | 1 |
2019 September | 0 | 3 | 3 |
2019 July | 0 | 2 | 2 |
2019 June | 0 | 7 | 7 |
2019 May | 0 | 44 | 44 |
2019 April | 0 | 1 | 1 |
2019 March | 0 | 9 | 9 |
2018 July | 0 | 1 | 1 |
2018 June | 0 | 3 | 3 |
2018 May | 0 | 4 | 4 |
2018 April | 0 | 2 | 2 |
2018 March | 1 | 0 | 1 |
2018 February | 17 | 4 | 21 |
2018 January | 24 | 10 | 34 |
2017 December | 17 | 8 | 25 |
2017 November | 18 | 2 | 20 |
2017 October | 12 | 6 | 18 |
2017 September | 9 | 10 | 19 |
2017 August | 16 | 9 | 25 |
2017 July | 12 | 3 | 15 |
2017 June | 16 | 12 | 28 |
2017 May | 15 | 6 | 21 |
2017 April | 12 | 18 | 30 |
2017 March | 14 | 18 | 32 |
2017 February | 21 | 7 | 28 |
2017 January | 9 | 9 | 18 |
2016 December | 22 | 9 | 31 |
2016 November | 24 | 7 | 31 |
2016 October | 22 | 7 | 29 |
2016 September | 22 | 9 | 31 |
2016 August | 41 | 10 | 51 |
2016 July | 37 | 10 | 47 |
2016 June | 15 | 0 | 15 |
2016 May | 4 | 14 | 18 |
2016 April | 3 | 0 | 3 |
2016 March | 4 | 0 | 4 |
2016 February | 12 | 4 | 16 |
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2015 October | 12 | 3 | 15 |
2015 September | 5 | 2 | 7 |
2015 August | 19 | 6 | 25 |
2015 July | 24 | 7 | 31 |
2015 June | 20 | 2 | 22 |
2015 May | 53 | 7 | 60 |
2015 April | 39 | 7 | 46 |
2015 March | 34 | 7 | 41 |
2015 February | 20 | 2 | 22 |
2015 January | 19 | 7 | 26 |
2014 December | 26 | 4 | 30 |
2014 November | 29 | 8 | 37 |
2014 October | 30 | 14 | 44 |
2014 September | 28 | 6 | 34 |
2014 August | 23 | 17 | 40 |
2014 July | 27 | 18 | 45 |
2014 June | 40 | 9 | 49 |
2014 May | 50 | 9 | 59 |
2014 April | 33 | 11 | 44 |
2014 March | 38 | 10 | 48 |
2014 February | 28 | 16 | 44 |
2014 January | 34 | 11 | 45 |
2013 December | 38 | 16 | 54 |
2013 November | 21 | 18 | 39 |
2013 October | 27 | 18 | 45 |
2013 September | 24 | 22 | 46 |
2013 August | 25 | 14 | 39 |
2013 July | 37 | 21 | 58 |
2013 June | 34 | 25 | 59 |
2013 May | 7 | 4 | 11 |
2013 April | 9 | 6 | 15 |
2013 March | 8 | 7 | 15 |
2013 February | 5 | 5 | 10 |