Adverse Reactions Related to the Administration of TNF Inhibitors. Analysis of a Registry of Biologic Therapy
Reacciones adversas relacionadas con la administración de inhibidores del TNF. Análisis de un registro de terapias biológicas
Unidad de Investigación, Fundación Española de Reumatología, Madrid, Spain
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"tienePdf" => "en" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "87" "paginaFinal" => "89" ] ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Loreto Carmona" "autores" => array:1 [ 0 => array:2 [ "nombre" => "Loreto" "apellidos" => "Carmona" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2173574308701631?idApp=UINPBA00004M" "url" => "/21735743/0000000400000003/v1_201305061545/S2173574308701631/v1_201305061545/en/main.assets" ] "en" => array:15 [ "idiomaDefecto" => true "titulo" => "Adverse Reactions Related to the Administration of TNF Inhibitors. Analysis of a Registry of Biologic Therapy" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "90" "paginaFinal" => "95" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Beatriz Pérez-Zafrilla, Miguel Ángel Descalzo, Loreto Carmona" "autores" => array:4 [ 0 => array:2 [ "nombre" => "Beatriz" "apellidos" => "Pérez-Zafrilla" ] 1 => array:2 [ "nombre" => "Miguel" "apellidos" => "Ángel Descalzo" ] 2 => array:3 [ "nombre" => "Loreto" "apellidos" => "Carmona" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">¿</span>" "identificador" => "cor0005" ] ] ] 3 => array:2 [ "colaborador" => "the BIOBADASER study group" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "fn0005" ] ] ] ] "afiliaciones" => array:1 [ 0 => array:1 [ "entidad" => "Unidad de Investigación, Fundación Española de Reumatología, Madrid, Spain" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Correspondence: Unidad de Investigación. Fundación Española de Reumatología. Marqués del Duero, 5, 1.°. 28001 Madrid. España." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Reacciones adversas relacionadas con la administración de inhibidores del TNF. Análisis de un registro de terapias biológicas" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2007-10-24" "fechaAceptado" => "2008-02-07" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Key words" "identificador" => "xpalclavsec111811" "palabras" => array:7 [ 0 => "Infliximab" 1 => "Etanercept" 2 => "Adalimumab" 3 => "Toxicity" 4 => "Adverse efects" 5 => "Registry" 6 => "Rheumatic diseases" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec111812" "palabras" => array:7 [ 0 => "Infliximab" 1 => "Etanercept" 2 => "Adalimumab" 3 => "Toxicidad" 4 => "Efectos adversos" 5 => "Registro" 6 => "Enfermedades reumáticas" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:1 [ "resumen" => "<span class="elsevierStyleSectionTitle">Objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To estimate the frequency of administration related reactions (ARR), the risk window from the starting date, and finally if there are any differences between infliximab, etanercept, and adalimumab.</p> <span class="elsevierStyleSectionTitle">Patients and method</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">BIOBADASER is an adverse event registry established in 2001 for active long-term follow-up of safety of biological therapies in rheumatic patients. Data from patients, diagnosis, treatment, and adverse events are recorded.</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Four-hundred ninety-six relevant ARR were registered, 19.6% (496/2531) of all the adverse events communicated and 6.3% (496/2531) of all the patients registered. The incidence rate per 1000 patients-year with infliximab is 28 cases (95% CI, 25-31), with etanercept 0.2 (95% CI, 0.1-0.4), and with adalimumab 0.2 (95% CI, 0.07-0.7). Treatment was interrupted in more than 50% of all the ARR and 5% of all patients were hospitalized. More than 20% ARR happened after 15 months of treatment; in addition 2 appeared after 5 years of treatment. In delayed reactions the symptoms that most frequently were recorded were rash, fever, malaise, and myalgia.</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">ARR can appear in any moment of the treatment; they are among the most frequent causes of treatment interruption. Although with less frequency, ARR are also associated with etanercept and adalimumab with symptoms that cannot be identified as such.</p>" ] "es" => array:1 [ "resumen" => "<span class="elsevierStyleSectionTitle">Objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Estimar la frecuencia de aparición de las reacciones relacionadas con la administración (RRA), los síntomas asociados a las graves o tardías, la ventana de exposición desde inicio de la terapia biológica y si hay diferencias entre infliximab, etanercept y adalimumab.</p> <span class="elsevierStyleSectionTitle">Pacientes y método</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">BIOBADASER es un registro de acontecimientos adversos establecido en 2001 para determinar la seguridad de las terapias biológicas en enfermedades reumáticas. Contiene datos de los pacientes, tratamiento y acontecimientos adversos relevantes.</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se registró un total de 496 RRA relevantes en 442 pacientes, lo que representa un 19,6% (496/2.531) de todos los acontecimientos adversos comunicados y un 6,3% de los pacientes registrados (442/6.969). La tasa de incidencia de RRA por 1.000 años-paciente con infliximab es de 28 casos (intervalo de confianza [IC] del 95%, 25-31), con etanercept 0,2 (IC del 95%, 0,1-0,4) y con adalimumab 0,2 (IC del 95%, 0,07-0,7). En más de la mitad de las RRA, el acontecimiento adverso da lugar a la interrupción del fármaco relacionado y en el 5% de los casos el paciente requiere ser hospitalizado. Más del 20% de las RRA ocurren después de 15 meses de tratamiento, incluso aparecen después de 5 años. En las reacciones adversas tardías los síntomas comunicados con más frecuencia son erupciones, fiebre, malestar general y mialgias.</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Las RRA pueden aparecer en cualquier momento de la enfermedad, son una de las causas más frecuentes de interrupción de tratamiento con infliximab. Aunque con menor frecuencia, también se relacionan con etanercept y adalimumab en síntomas que pueden no identificarse como tales.</p>" ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "nota" => "<p class="elsevierStyleNotepara">The names of the BIOBADASER study group are shown at the end of the article.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1." 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| 2015 July | 27 | 6 | 33 |
| 2015 June | 14 | 15 | 29 |
| 2015 May | 19 | 25 | 44 |
| 2015 April | 21 | 23 | 44 |
| 2015 March | 11 | 11 | 22 |
| 2015 February | 11 | 16 | 27 |
| 2015 January | 6 | 11 | 17 |
| 2014 December | 14 | 16 | 30 |
| 2014 November | 15 | 14 | 29 |
| 2014 October | 14 | 15 | 29 |
| 2014 September | 12 | 10 | 22 |
| 2014 August | 16 | 13 | 29 |
| 2014 July | 15 | 11 | 26 |
| 2014 June | 29 | 8 | 37 |
| 2014 May | 29 | 12 | 41 |
| 2014 April | 22 | 11 | 33 |
| 2014 March | 27 | 24 | 51 |
| 2014 February | 24 | 17 | 41 |
| 2014 January | 16 | 18 | 34 |
| 2013 December | 27 | 12 | 39 |
| 2013 November | 17 | 5 | 22 |
| 2013 October | 20 | 10 | 30 |
| 2013 September | 26 | 19 | 45 |
| 2013 August | 22 | 8 | 30 |
| 2013 July | 22 | 8 | 30 |
| 2013 June | 19 | 17 | 36 |
| 2013 May | 12 | 9 | 21 |
| 2013 April | 17 | 13 | 30 |
| 2013 March | 16 | 10 | 26 |
| 2013 February | 20 | 8 | 28 |
| 2013 January | 15 | 14 | 29 |
| 2012 December | 17 | 14 | 31 |
| 2012 November | 9 | 27 | 36 |
| 2012 October | 11 | 11 | 22 |
| 2012 September | 7 | 9 | 16 |
| 2012 June | 4 | 0 | 4 |
| 2012 May | 3 | 0 | 3 |
| 2012 April | 4 | 0 | 4 |
| 2012 March | 3 | 0 | 3 |
| 2012 February | 3 | 0 | 3 |
| 2012 January | 3 | 0 | 3 |
| 2011 December | 5 | 0 | 5 |
| 2011 November | 4 | 0 | 4 |
| 2011 October | 4 | 0 | 4 |
| 2011 September | 3 | 0 | 3 |
| 2011 August | 2 | 0 | 2 |
| 2011 July | 4 | 0 | 4 |
| 2011 June | 6 | 0 | 6 |
| 2011 May | 4 | 0 | 4 |
| 2011 April | 4 | 0 | 4 |
| 2011 March | 5 | 0 | 5 |
| 2011 February | 9 | 0 | 9 |
| 2011 January | 12 | 0 | 12 |
| 2010 December | 9 | 0 | 9 |
| 2010 November | 11 | 0 | 11 |
| 2010 October | 10 | 0 | 10 |
| 2010 September | 8 | 0 | 8 |
| 2010 August | 6 | 0 | 6 |
| 2010 July | 4 | 0 | 4 |
| 2010 June | 2 | 0 | 2 |
| 2010 May | 6 | 0 | 6 |
| 2010 April | 6 | 0 | 6 |
| 2010 March | 15 | 0 | 15 |
| 2010 February | 3 | 0 | 3 |
| 2010 January | 8 | 0 | 8 |
| 2009 December | 57 | 0 | 57 |
| 2009 November | 11 | 0 | 11 |
| 2009 October | 6 | 0 | 6 |
| 2009 September | 6 | 0 | 6 |
| 2009 August | 11 | 0 | 11 |
| 2009 July | 10 | 0 | 10 |
| 2009 June | 12 | 0 | 12 |
| 2009 May | 6 | 0 | 6 |
| 2009 April | 22 | 0 | 22 |
| 2009 March | 8 | 0 | 8 |
Show all
