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        "titulo" => "Abstract"
        "resumen" => "<span class="elsevierStyleSectionTitle">Background and objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The Working Group on Psoriasis of the Spanish Academy of Dermatology and Venereology has initiated BIOBADADERM&#44; a registry of patients with psoriasis receiving treatment with biologic drugs&#44; in order to assess the long-term risk of adverse events &#40;AEs&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Material and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A multicenter study was undertaken in 2 cohorts of patients with psoriasis&#58; patients receiving biologic therapy and patients receiving nonbiologic systemic therapy other than phototherapy&#46; Similar numbers of patients were included in each group&#46; Information was recorded on demographic and clinical variables&#44; treatment&#44; and relevant AEs&#46; The risk of specific AEs was determined by comparison of the frequencies for those events in the 2 cohorts&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Data on the 2 cohorts were evaluated for the period from October&#44; 2008 to November&#44; 2009 alongside retrospective data on patients treated with biologics since 2005&#46; Thirteen Spanish hospitals participated in the study&#46; A total of 632 patients were included in the analysis&#58; 417 treated with biologic drugs and 215 controls&#46; Suspension of biologic therapy due to AEs was rare &#40;72 cycles&#44; 10&#37;&#41;&#46; A total of 232 AEs were reported in patients receiving biologic therapy&#46; The majority were not serious&#46; The most frequent AEs were infections &#40;mostly upper respiratory tract infections and nasopharyngitis&#41;&#44; followed by conditions affecting the skin or subcutaneous tissue&#46; Forty-three AEs were reported in control subjects&#46; The most frequent events were metabolic and nutritional abnormalities and abnormal transaminase levels&#46; Comparison of the incidence of any AE in patients treated with biologics compared with control subjects revealed a relative risk of 2&#46;2 &#40;P&#60;&#46;001&#41; The relative risks of infections or infestations and disorders of the skin or subcutaneous tissue in patients receiving biologic drugs were 23 &#40;P&#60;&#46;01&#41; and 4&#46;9 &#40;P&#60;&#46;05&#41;&#44; respectively&#46;</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Patients treated with biologic drugs had a greater number of AEs&#44; particularly infections and skin conditions&#46; Definitive conclusions&#44; however&#44; are difficult to draw due to the small number of patients included in the registry&#44; particularly in the control cohort&#44; and the short follow-up period&#46; Differences in the percentages of events reported by the different hospitals reveal the difficulties associated with the concept of AEs in clinical practice and highlight the need to harmonize criteria in the future&#46; Since the problems identified in this analysis should be overcome in future years&#44; we expect BIOBADADERM to become an important source of information on the safety profile of biologic drugs in dermatology&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Introducci&#243;n y objetivos</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">El Grupo de Psoriasis de la Academia Espa&#241;ola de Dermatolog&#237;a y Venereolog&#237;a &#40;AEDV&#41; ha puesto en marcha un registro de pacientes con psoriasis en tratamiento con agentes biol&#243;gicos&#44; con el objetivo de analizar el riesgo de acontecimientos adversos &#40;AA&#41; relevantes a largo plazo&#58; BIOBADADERM&#46;</p> <span class="elsevierStyleSectionTitle">Material y m&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Es un estudio de cohortes multic&#233;ntrico&#44; con una cohorte de pacientes con psoriasis en terapia biol&#243;gica y otra cohorte control de pacientes con psoriasis con tratamiento sist&#233;mico no biol&#243;gico&#44; excluida la fototerapia&#44; en una relaci&#243;n 1&#58;1&#46; Se registraron los datos b&#225;sicos de cada paciente&#44; de los tratamientos y de los AA relevantes&#46; Se analiz&#243; el riesgo asociado a un AA concreto&#44; comparando su frecuencia de aparici&#243;n en ambas cohortes&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se evaluaron los datos desde octubre de 2008 hasta noviembre de 2009 junto con datos retrospectivos desde 2005 sobre pacientes tratados con agentes biol&#243;gicos&#46; Participaron 13 hospitales de Espa&#241;a&#46; Se incluyeron 632 pacientes&#44; 417 con biol&#243;gicos y 215 controles&#46; La suspensi&#243;n del tratamiento biol&#243;gico por AA fue poco frecuente &#40;72 ciclos&#44; 10&#37;&#41;&#46; Se comunicaron 232 AA en los pacientes con biol&#243;gicos&#44; la mayor&#237;a no graves&#44; los m&#225;s frecuentes las infecciones &#40;la mayor&#237;a del tracto respiratorio superior&#47;nasofaringitis&#41;&#44; seguidos de los trastornos de la piel y el tejido subcut&#225;neo&#46; Entre los controles se notificaron 43 AA&#46; Los m&#225;s frecuentes fueron los trastornos del metabolismo y la nutrici&#243;n y las alteraciones en las transaminasas&#46; En t&#233;rminos de incidencia de AA&#44; los biol&#243;gicos presentaron un riesgo relativo &#40;RR&#41; de AA de 2&#44;2 respecto a los controles &#40;p &#60; 0&#44;001&#41;&#46; En particular destacaron las infecciones e infestaciones &#40;con un RR de 23 con p&#60;0&#44;01&#41; y los trastornos de la piel y el tejido subcut&#225;neo &#40;RR&#58; 4&#44;9 con p &#60; 0&#44;05&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Los pacientes tratados con f&#225;rmacos biol&#243;gicos presentan mayor n&#250;mero de AA que los controles&#44; en particular en referencia a las infecciones y los trastornos de la piel&#46; Sin embargo&#44; debe tenerse en cuenta que tanto el tiempo de seguimiento como el limitado n&#250;mero de pacientes reclutados &#8212;en particular en el grupo de controles&#8212; impide extraer conclusiones definitivas&#46; Por otro lado&#44; la diferencia de porcentajes de AA referidos por los distintos centros pone de manifiesto la dificultad de la consideraci&#243;n del concepto de AA en la pr&#225;ctica cl&#237;nica&#44; siendo necesario homogeneizar los criterios&#46; un a pesar de los problemas planteados&#44; que deber&#225;n superarse en los pr&#243;ximos a&#241;os&#44; BIOBADADERM puede convertirse en la referencia obligada en la evaluaci&#243;n del perfil de seguridad de los f&#225;rmacos biol&#243;gicos en Dermatolog&#237;a&#46;</p>"
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BIOBADADERM, the Spanish Registry of Adverse Events Associated With Biologic Drugs in Dermatology: First Report
BIOBADADERM: registro español de acontecimientos adversos de terapias biológicas en Dermatología. Primer informe
R. Rivera
Corresponding author
rriveradiaz@hotmail.com

Corresponding author.
, I. García-Doval, G. Carretero, E. Daudén, J. Sánchez-Carazo, C. Ferrándiz, E. Herrera, M. Alsina, M. Ferrán, J.L. López-Estebaranz, F. Gómez, J.M. Herranz, J.M. Carrascosa, F. Vanaclocha, members of the BIOBADADERM Group
Members of the BIOBADADERM Group and the Working Group on Psoriasis of the Spanish Academy of Dermatology and Venereology
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      "es" => array:1 [
        "titulo" => "BIOBADADERM&#58; registro espa&#241;ol de acontecimientos adversos de terapias biol&#243;gicas en Dermatolog&#237;a&#46; Primer informe"
      ]
    ]
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    "fechaRecibido" => "2010-09-21"
    "fechaAceptado" => "2010-10-17"
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          "clase" => "keyword"
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          "palabras" => array:7 [
            0 => "Biologic therapies"
            1 => "Psoriasis"
            2 => "Adverse events"
            3 => "Registry"
            4 => "Incidence"
            5 => "Prognosis"
            6 => "Cohort"
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          "palabras" => array:7 [
            0 => "Tratamientos biol&#243;gicos"
            1 => "Psoriasis"
            2 => "Acontecimientos adversos"
            3 => "Registro"
            4 => "Incidencia"
            5 => "Pron&#243;stico"
            6 => "Cohorte"
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      "en" => array:2 [
        "titulo" => "Abstract"
        "resumen" => "<span class="elsevierStyleSectionTitle">Background and objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The Working Group on Psoriasis of the Spanish Academy of Dermatology and Venereology has initiated BIOBADADERM&#44; a registry of patients with psoriasis receiving treatment with biologic drugs&#44; in order to assess the long-term risk of adverse events &#40;AEs&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Material and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A multicenter study was undertaken in 2 cohorts of patients with psoriasis&#58; patients receiving biologic therapy and patients receiving nonbiologic systemic therapy other than phototherapy&#46; Similar numbers of patients were included in each group&#46; Information was recorded on demographic and clinical variables&#44; treatment&#44; and relevant AEs&#46; The risk of specific AEs was determined by comparison of the frequencies for those events in the 2 cohorts&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Data on the 2 cohorts were evaluated for the period from October&#44; 2008 to November&#44; 2009 alongside retrospective data on patients treated with biologics since 2005&#46; Thirteen Spanish hospitals participated in the study&#46; A total of 632 patients were included in the analysis&#58; 417 treated with biologic drugs and 215 controls&#46; Suspension of biologic therapy due to AEs was rare &#40;72 cycles&#44; 10&#37;&#41;&#46; A total of 232 AEs were reported in patients receiving biologic therapy&#46; The majority were not serious&#46; The most frequent AEs were infections &#40;mostly upper respiratory tract infections and nasopharyngitis&#41;&#44; followed by conditions affecting the skin or subcutaneous tissue&#46; Forty-three AEs were reported in control subjects&#46; The most frequent events were metabolic and nutritional abnormalities and abnormal transaminase levels&#46; Comparison of the incidence of any AE in patients treated with biologics compared with control subjects revealed a relative risk of 2&#46;2 &#40;P&#60;&#46;001&#41; The relative risks of infections or infestations and disorders of the skin or subcutaneous tissue in patients receiving biologic drugs were 23 &#40;P&#60;&#46;01&#41; and 4&#46;9 &#40;P&#60;&#46;05&#41;&#44; respectively&#46;</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Patients treated with biologic drugs had a greater number of AEs&#44; particularly infections and skin conditions&#46; Definitive conclusions&#44; however&#44; are difficult to draw due to the small number of patients included in the registry&#44; particularly in the control cohort&#44; and the short follow-up period&#46; Differences in the percentages of events reported by the different hospitals reveal the difficulties associated with the concept of AEs in clinical practice and highlight the need to harmonize criteria in the future&#46; Since the problems identified in this analysis should be overcome in future years&#44; we expect BIOBADADERM to become an important source of information on the safety profile of biologic drugs in dermatology&#46;</p>"
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      "es" => array:2 [
        "titulo" => "Resumen"
        "resumen" => "<span class="elsevierStyleSectionTitle">Introducci&#243;n y objetivos</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">El Grupo de Psoriasis de la Academia Espa&#241;ola de Dermatolog&#237;a y Venereolog&#237;a &#40;AEDV&#41; ha puesto en marcha un registro de pacientes con psoriasis en tratamiento con agentes biol&#243;gicos&#44; con el objetivo de analizar el riesgo de acontecimientos adversos &#40;AA&#41; relevantes a largo plazo&#58; BIOBADADERM&#46;</p> <span class="elsevierStyleSectionTitle">Material y m&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Es un estudio de cohortes multic&#233;ntrico&#44; con una cohorte de pacientes con psoriasis en terapia biol&#243;gica y otra cohorte control de pacientes con psoriasis con tratamiento sist&#233;mico no biol&#243;gico&#44; excluida la fototerapia&#44; en una relaci&#243;n 1&#58;1&#46; Se registraron los datos b&#225;sicos de cada paciente&#44; de los tratamientos y de los AA relevantes&#46; Se analiz&#243; el riesgo asociado a un AA concreto&#44; comparando su frecuencia de aparici&#243;n en ambas cohortes&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se evaluaron los datos desde octubre de 2008 hasta noviembre de 2009 junto con datos retrospectivos desde 2005 sobre pacientes tratados con agentes biol&#243;gicos&#46; Participaron 13 hospitales de Espa&#241;a&#46; Se incluyeron 632 pacientes&#44; 417 con biol&#243;gicos y 215 controles&#46; La suspensi&#243;n del tratamiento biol&#243;gico por AA fue poco frecuente &#40;72 ciclos&#44; 10&#37;&#41;&#46; Se comunicaron 232 AA en los pacientes con biol&#243;gicos&#44; la mayor&#237;a no graves&#44; los m&#225;s frecuentes las infecciones &#40;la mayor&#237;a del tracto respiratorio superior&#47;nasofaringitis&#41;&#44; seguidos de los trastornos de la piel y el tejido subcut&#225;neo&#46; Entre los controles se notificaron 43 AA&#46; Los m&#225;s frecuentes fueron los trastornos del metabolismo y la nutrici&#243;n y las alteraciones en las transaminasas&#46; En t&#233;rminos de incidencia de AA&#44; los biol&#243;gicos presentaron un riesgo relativo &#40;RR&#41; de AA de 2&#44;2 respecto a los controles &#40;p &#60; 0&#44;001&#41;&#46; En particular destacaron las infecciones e infestaciones &#40;con un RR de 23 con p&#60;0&#44;01&#41; y los trastornos de la piel y el tejido subcut&#225;neo &#40;RR&#58; 4&#44;9 con p &#60; 0&#44;05&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Los pacientes tratados con f&#225;rmacos biol&#243;gicos presentan mayor n&#250;mero de AA que los controles&#44; en particular en referencia a las infecciones y los trastornos de la piel&#46; Sin embargo&#44; debe tenerse en cuenta que tanto el tiempo de seguimiento como el limitado n&#250;mero de pacientes reclutados &#8212;en particular en el grupo de controles&#8212; impide extraer conclusiones definitivas&#46; Por otro lado&#44; la diferencia de porcentajes de AA referidos por los distintos centros pone de manifiesto la dificultad de la consideraci&#243;n del concepto de AA en la pr&#225;ctica cl&#237;nica&#44; siendo necesario homogeneizar los criterios&#46; un a pesar de los problemas planteados&#44; que deber&#225;n superarse en los pr&#243;ximos a&#241;os&#44; BIOBADADERM puede convertirse en la referencia obligada en la evaluaci&#243;n del perfil de seguridad de los f&#225;rmacos biol&#243;gicos en Dermatolog&#237;a&#46;</p>"
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Article information
ISSN: 15782190
Original language: English
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Idiomas
Actas Dermo-Sifiliográficas
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