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        "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&#44; 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&#46; 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&#46; As secondary objectives&#44; we sought to assess the relationships between clinical characteristics&#44; treatment response&#44; and disease course during efalizumab treatment and 12 and 24 weeks after suspension&#46;</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&#46; Statistical analyses were performed to identify predictive factors&#46;</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&#46; During treatment&#44; 4&#37; of patients were diagnosed with generalized inflammatory flares&#46; Most patients could be classified as having a good &#40;55&#37;&#41; or moderate &#40;18&#37;&#41; response to treatment&#46; Rebound following withdrawal of efalizumab was observed in 30&#37; of patients&#46; The likelihood of rebound was independent of clinical characteristics&#44; treatment response&#44; or therapeutic approach used by the dermatologist following suspension&#46;</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">There was a high frequency of rebound following suspension of efalizumab&#44; exceeding the rate reported in pivotal trials&#46; This is particularly noteworthy given the large proportion of patients with a good response to treatment and therefore believed to have a better prognosis&#46; Other significant findings were the higher frequency of positive treatment response than observed in previous studies &#40;possibly influenced by the mean treatment duration&#41; and the high frequency of generalized inflammatory flares&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Introducci&#243;n</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">La reciente resoluci&#243;n de la EMEA con respecto a la suspensi&#243;n de efalizumab&#44; ocurrida en febrero del a&#241;o 2009&#44; ha proporcionado una oportunidad &#250;nica para comprobar la evoluci&#243;n de un grupo de pacientes en cuya selecci&#243;n no intervinieron los filtros ni los sesgos habituales de los estudios pivotales&#46; El objetivo planteado fue evaluar el curso de la psoriasis tras la suspensi&#243;n forzosa de efalizumab en un grupo de pacientes tratados en el &#225;mbito cl&#237;nico&#46; Como objetivos secundarios se plante&#243; investigar su perfil cl&#237;nico&#44; la respuesta y evoluci&#243;n durante el tratamiento y el curso evolutivo a las 12 y 24 semanas tras la suspensi&#243;n&#46;</p> <span class="elsevierStyleSectionTitle">Pacientes y m&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se recogi&#243; informaci&#243;n procedente de un grupo de pacientes tratados con efalizumab referida al perfil epidemiol&#243;gico&#44; al curso de la dermatosis durante el tratamiento y a su evoluci&#243;n al suspenderlo&#46; Se llevaron a cabo estudios estad&#237;sticos con vistas a identificar variables predictivas de los distintos objetivos investigados&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 147 pacientes procedentes de 12 centros hospitalarios nacionales&#46; Durante el tratamiento un 4&#37; de los pacientes fue diagnosticado de exacerbaci&#243;n inflamatoria generalizada&#46; La mayor parte de los pacientes pudieron ser clasificados como buenos respondedores &#40;55&#37;&#41; o respondedores moderados &#40;18&#37;&#41;&#46; Un 30&#37; de los pacientes presentaron rebote tras la suspensi&#243;n de efalizumab&#46; La probabilidad de rebote fue independiente del perfil cl&#237;nico&#44; la respuesta al tratamiento o la actitud terap&#233;utica del dermat&#243;logo al suspenderlo&#46;</p> <span class="elsevierStyleSectionTitle">Discusi&#243;n y conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Se comprob&#243; una elevada ocurrencia de fen&#243;meno de rebote tras la suspensi&#243;n de efalizumab&#44; superior a la descrita en los ensayos cl&#237;nicos pivotales y especialmente significativa si se tiene en cuenta la elevada incidencia de buenos respondedores durante el tratamiento&#44; considerados de mejor pron&#243;stico&#46; Otros datos significativos son la superior perspectiva de respuesta cl&#237;nica &#8211;presumiblemente condicionada por el tiempo medio de tratamiento&#8211;&#44; y la elevada incidencia de episodios de exacerbaci&#243;n inflamatoria generalizada&#46;</p>"
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Original Article
Clinical Characteristics and Disease Course in Patients Treated With Efalizumab Following Suspension of Marketing Authorization by the European Medicines Agency: A Multicenter Observational Study
Perfil clínico y curso evolutivo de los pacientes tratados con efalizumab tras la suspensión de su autorización por la EMEA. Estudio observacional y multicéntrico
L. Morella,
Corresponding author
laiamorell@hotmail.com

Corresponding author.
, J.M. Carrascosaa, C. Ferrándiza, M. García-Bustinduyb, E. Fonsecac, G. Carreterod, E. Daudéne, S.E. Marrónf, J.L. López-Estebaranzg, M. Ferránh, M. Sánchez-Regañai, C. Muñoz-Santosj, I. Belinchónk, Luis Puigl, on behalf of the Spanish Psoriasis Group
a Servicio de Dermatología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
b Servicio de Dermatología, Hospital Universitario de Canarias, Islas Canarias, Spain
c Servicio de Dermatología, Hospital Juan Canalejo, La Coruña, Spain
d Servicio de Dermatología, Hospital Universitario de Canarias Dr. Negrín, Islas Canarias, Spain
e Servicio de Dermatología, Hospital Universitario de la Princesa, Madrid, Spain
f Servicio de Dermatología, Hospital de Calatayud, Instituto Aragonés de Ciencias de la Salud, Zaragoza, Spain
g Servicio de Dermatología, Hospital de Alcorcón, Madrid, Spain
h Servicio de Dermatología, Hospital del Mar, Barcelona, Spain
i Servicio de Dermatología, Hospital del Sagrat Cor, Barcelona, Spain
j Servicio de Dermatología, Hospital Clínic i Provincial, Barcelona, Spain
k Servicio de Dermatología, Hospital General de Alicante, Alicante, Spain
l Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
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        "titulo" => "Perfil cl&#237;nico y curso evolutivo de los pacientes tratados con efalizumab tras la suspensi&#243;n de su autorizaci&#243;n por la EMEA&#46; Estudio observacional y multic&#233;ntrico"
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    "fechaRecibido" => "2010-10-22"
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      "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&#44; 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&#46; 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&#46; As secondary objectives&#44; we sought to assess the relationships between clinical characteristics&#44; treatment response&#44; and disease course during efalizumab treatment and 12 and 24 weeks after suspension&#46;</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&#46; Statistical analyses were performed to identify predictive factors&#46;</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&#46; During treatment&#44; 4&#37; of patients were diagnosed with generalized inflammatory flares&#46; Most patients could be classified as having a good &#40;55&#37;&#41; or moderate &#40;18&#37;&#41; response to treatment&#46; Rebound following withdrawal of efalizumab was observed in 30&#37; of patients&#46; The likelihood of rebound was independent of clinical characteristics&#44; treatment response&#44; or therapeutic approach used by the dermatologist following suspension&#46;</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">There was a high frequency of rebound following suspension of efalizumab&#44; exceeding the rate reported in pivotal trials&#46; This is particularly noteworthy given the large proportion of patients with a good response to treatment and therefore believed to have a better prognosis&#46; Other significant findings were the higher frequency of positive treatment response than observed in previous studies &#40;possibly influenced by the mean treatment duration&#41; and the high frequency of generalized inflammatory flares&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Introducci&#243;n</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">La reciente resoluci&#243;n de la EMEA con respecto a la suspensi&#243;n de efalizumab&#44; ocurrida en febrero del a&#241;o 2009&#44; ha proporcionado una oportunidad &#250;nica para comprobar la evoluci&#243;n de un grupo de pacientes en cuya selecci&#243;n no intervinieron los filtros ni los sesgos habituales de los estudios pivotales&#46; El objetivo planteado fue evaluar el curso de la psoriasis tras la suspensi&#243;n forzosa de efalizumab en un grupo de pacientes tratados en el &#225;mbito cl&#237;nico&#46; Como objetivos secundarios se plante&#243; investigar su perfil cl&#237;nico&#44; la respuesta y evoluci&#243;n durante el tratamiento y el curso evolutivo a las 12 y 24 semanas tras la suspensi&#243;n&#46;</p> <span class="elsevierStyleSectionTitle">Pacientes y m&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se recogi&#243; informaci&#243;n procedente de un grupo de pacientes tratados con efalizumab referida al perfil epidemiol&#243;gico&#44; al curso de la dermatosis durante el tratamiento y a su evoluci&#243;n al suspenderlo&#46; Se llevaron a cabo estudios estad&#237;sticos con vistas a identificar variables predictivas de los distintos objetivos investigados&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 147 pacientes procedentes de 12 centros hospitalarios nacionales&#46; Durante el tratamiento un 4&#37; de los pacientes fue diagnosticado de exacerbaci&#243;n inflamatoria generalizada&#46; La mayor parte de los pacientes pudieron ser clasificados como buenos respondedores &#40;55&#37;&#41; o respondedores moderados &#40;18&#37;&#41;&#46; Un 30&#37; de los pacientes presentaron rebote tras la suspensi&#243;n de efalizumab&#46; La probabilidad de rebote fue independiente del perfil cl&#237;nico&#44; la respuesta al tratamiento o la actitud terap&#233;utica del dermat&#243;logo al suspenderlo&#46;</p> <span class="elsevierStyleSectionTitle">Discusi&#243;n y conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Se comprob&#243; una elevada ocurrencia de fen&#243;meno de rebote tras la suspensi&#243;n de efalizumab&#44; superior a la descrita en los ensayos cl&#237;nicos pivotales y especialmente significativa si se tiene en cuenta la elevada incidencia de buenos respondedores durante el tratamiento&#44; considerados de mejor pron&#243;stico&#46; Otros datos significativos son la superior perspectiva de respuesta cl&#237;nica &#8211;presumiblemente condicionada por el tiempo medio de tratamiento&#8211;&#44; y la elevada incidencia de episodios de exacerbaci&#243;n inflamatoria generalizada&#46;</p>"
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Article information
ISSN: 15782190
Original language: English
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