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      "en" => array:2 [
        "titulo" => "Abstract"
        "resumen" => "<span class="elsevierStyleSectionTitle">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">In February 2009&#44; the European Medicines Agency suspended the marketing authorization for efalizumab after 3 confirmed cases of progressive multifocal leukoencephalopathy were reported&#46; To assess the consequences of this decision&#44; 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&#46;</p> <span class="elsevierStyleSectionTitle">Patients and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Thirty-two patients &#40;28 with plaque psoriasis and 4 with palmoplantar psoriasis&#41; were enrolled between February and March 2009&#46; We recorded psoriasis area and severity index &#40;PASI&#41; scores at the moment of efalizumab discontinuation&#44; at 6 weeks post-discontinuation&#44; and at 3-monthly intervals thereafter&#46; PASI scores prior to treatment with efalizumab were also noted&#46; For patients who experienced rebounds with generalized psoriasis&#44; we noted the time that had elapsed since efalizumab discontinuation and the treatment they were receiving&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Even though 92&#46;8&#37; of the patients were considered good responders &#40;&#62;75&#37; reduction in PASI score&#41;&#44; 25&#37; of the group &#40;8&#47;32&#41; experienced rebound and 15&#46;7&#37; &#40;5&#47;32&#41; experienced relapse&#46; The percentage of patients in whom rebound was observed on transition therapy was 18&#37; &#40;2&#47;11&#41; for cyclosporin&#44; 50&#37; &#40;1&#47;2&#41; for methotrexate&#44; 50&#37; &#40;1&#47;2&#41; for adalimumab&#44; 50&#37; &#40;1&#47;2&#41; for etanercept&#44; and 27&#37; &#40;3&#47;11&#41; for topical treatment&#46;</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&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Introducci&#243;n</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">En febrero de 2009 la Agencia Europea de Evaluaci&#243;n de Medicamentos &#40;EMEA&#41; suspendi&#243; la comercializaci&#243;n de efalizumab por la notificaci&#243;n de tres casos confirmados de leucoencefalopat&#237;a multifocal progresiva &#40;LMP&#41;&#46; Nos planteamos realizar un estudio prospectivo de seguimiento de los pacientes tratados en nuestro Servicio con efalizumab en el momento de la suspensi&#243;n y comparar la evoluci&#243;n con las perspectivas publicadas en la literatura&#46;</p> <span class="elsevierStyleSectionTitle">Pacientes y m&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 32 pacientes &#40;28 con psoriasis en placas y 4 con psoriasis palmoplantar&#41; entre febrero y marzo de 2009&#46; Se recogi&#243; el Psoriasis Area and Severity Index &#40;PASI&#41; previo al comienzo del tratamiento con efalizumab&#44; en el momento de la suspensi&#243;n&#44; a las 6 semanas y posteriormente cada tres meses&#46; En el caso de los pacientes que presentaron brotes generalizados se recogi&#243; el tiempo transcurrido desde la suspensi&#243;n y el manejo terap&#233;utico que se realiz&#243;&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">A pesar de que el 92&#44;8&#37; de los pacientes correspond&#237;an a buenos respondedores &#40;mejor&#237;a PASI &#62; 75&#41;&#44; presentaron rebote un 25&#37; de los sujetos &#40;8&#47;32&#41; y reca&#237;das un 15&#44;7&#37; &#40;5&#47;32&#41;&#46; Con respecto a la terapia de transici&#243;n presentaron rebote un 18&#37; de los pacientes &#40;2&#47;11&#41; con ciclosporina&#44; un 50&#37; &#40;1&#47;2&#41; con metotrexato&#44; un 50&#37; &#40;1&#47;2&#41; con adalimumab&#44; un 50&#37; &#40;1&#47;2&#41; con etanercept y un 27&#37; &#40;3&#47;11&#41; de los que recibieron tratamiento t&#243;pico&#46;</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 hab&#237;an conseguido un buen control de la psoriasis durante varios a&#241;os&#46;</p>"
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Vol. 101. Núm. 5.
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Vol. 101. Núm. 5.
Páginas 421-427 (junio - julio 2010)
Original article
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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
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O. Baniandrés
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ofelia_baniandres@yahoo.es

Corresponding author.
, A. Pulido, C. Silvente, R. Suárez, P. Lázaro
Servicio de Dermatología, Hospital General Universitario Gregorio Marañón, Madrid, Spain
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Abstract
Introduction

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.

Patients and methods

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.

Results

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.

Conclusions

We observed a very high rate of rebound and generalized inflammation in patients whose disease had previously been well controlled for several years.

Keywords:
Efalizumab
Progressive multifocal leukoencephalopathy
Psoriasis
Rebound
Relapse
Treatment discontinuation
Resumen
Introducción

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.

Pacientes y métodos

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.

Resultados

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.

Conclusiones

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.

Palabras clave:
Efalizumab
Leucoencefalopatía multifocal progresiva
Psoriasis
Rebote
Recaída
Suspensión
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Copyright © 2010. Academia Española de Dermatología y Venereología and Elsevier España, S.L.
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