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        "resumen" => "<span class="elsevierStyleSectionTitle">Objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To estimate the frequency of administration related reactions &#40;ARR&#41;&#44; the risk window from the starting date&#44; and finally if there are any differences between infliximab&#44; etanercept&#44; and adalimumab&#46;</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&#46; Data from patients&#44; diagnosis&#44; treatment&#44; and adverse events are recorded&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Four-hundred ninety-six relevant ARR were registered&#44; 19&#46;6&#37; &#40;496&#47;2531&#41; of all the adverse events communicated and 6&#46;3&#37; &#40;496&#47;2531&#41; of all the patients registered&#46; The incidence rate per 1000 patients-year with infliximab is 28 cases &#40;95&#37; CI&#44; 25-31&#41;&#44; with etanercept 0&#46;2 &#40;95&#37; CI&#44; 0&#46;1-0&#46;4&#41;&#44; and with adalimumab 0&#46;2 &#40;95&#37; CI&#44; 0&#46;07-0&#46;7&#41;&#46; Treatment was interrupted in more than 50&#37; of all the ARR and 5&#37; of all patients were hospitalized&#46; More than 20&#37; ARR happened after 15 months of treatment&#59; in addition 2 appeared after 5 years of treatment&#46; In delayed reactions the symptoms that most frequently were recorded were rash&#44; fever&#44; malaise&#44; and myalgia&#46;</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">ARR can appear in any moment of the treatment&#59; they are among the most frequent causes of treatment interruption&#46; Although with less frequency&#44; ARR are also associated with etanercept and adalimumab with symptoms that cannot be identified as such&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Estimar la frecuencia de aparici&#243;n de las reacciones relacionadas con la administraci&#243;n &#40;RRA&#41;&#44; los s&#237;ntomas asociados a las graves o tard&#237;as&#44; la ventana de exposici&#243;n desde inicio de la terapia biol&#243;gica y si hay diferencias entre infliximab&#44; etanercept y adalimumab&#46;</p> <span class="elsevierStyleSectionTitle">Pacientes y m&#233;todo</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">BIOBADASER es un registro de acontecimientos adversos establecido en 2001 para determinar la seguridad de las terapias biol&#243;gicas en enfermedades reum&#225;ticas&#46; Contiene datos de los pacientes&#44; tratamiento y acontecimientos adversos relevantes&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se registr&#243; un total de 496 RRA relevantes en 442 pacientes&#44; lo que representa un 19&#44;6&#37; &#40;496&#47;2&#46;531&#41; de todos los acontecimientos adversos comunicados y un 6&#44;3&#37; de los pacientes registrados &#40;442&#47;6&#46;969&#41;&#46; La tasa de incidencia de RRA por 1&#46;000 a&#241;os-paciente con infliximab es de 28 casos &#40;intervalo de confianza &#91;IC&#93; del 95&#37;&#44; 25-31&#41;&#44; con etanercept 0&#44;2 &#40;IC del 95&#37;&#44; 0&#44;1-0&#44;4&#41; y con adalimumab 0&#44;2 &#40;IC del 95&#37;&#44; 0&#44;07-0&#44;7&#41;&#46; En m&#225;s de la mitad de las RRA&#44; el acontecimiento adverso da lugar a la interrupci&#243;n del f&#225;rmaco relacionado y en el 5&#37; de los casos el paciente requiere ser hospitalizado&#46; M&#225;s del 20&#37; de las RRA ocurren despu&#233;s de 15 meses de tratamiento&#44; incluso aparecen despu&#233;s de 5 a&#241;os&#46; En las reacciones adversas tard&#237;as los s&#237;ntomas comunicados con m&#225;s frecuencia son erupciones&#44; fiebre&#44; malestar general y mialgias&#46;</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Las RRA pueden aparecer en cualquier momento de la enfermedad&#44; son una de las causas m&#225;s frecuentes de interrupci&#243;n de tratamiento con infliximab&#46; Aunque con menor frecuencia&#44; tambi&#233;n se relacionan con etanercept y adalimumab en s&#237;ntomas que pueden no identificarse como tales&#46;</p>"
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Vol. 4. Issue 3.
Pages 90-95 (May - June 2008)
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Vol. 4. Issue 3.
Pages 90-95 (May - June 2008)
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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
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Beatriz Pérez-Zafrilla, Miguel Ángel Descalzo, Loreto Carmona
, the BIOBADASER study group *
Unidad de Investigación, Fundación Española de Reumatología, Madrid, Spain
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Article information
Objective

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.

Patients and method

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.

Results

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.

Conclusions

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.

Key words:
Infliximab
Etanercept
Adalimumab
Toxicity
Adverse efects
Registry
Rheumatic diseases
Objetivo

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.

Pacientes y método

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.

Resultados

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.

Conclusiones

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.

Palabras clave:
Infliximab
Etanercept
Adalimumab
Toxicidad
Efectos adversos
Registro
Enfermedades reumáticas
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Incidence of infusion related reactions in patients receiving infliximab: recommendations for administration recommendations [abstract].
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The names of the BIOBADASER study group are shown at the end of the article.

Copyright © 2008. Sociedad Española de Reumatología and Colegio Mexicano de Reumatología
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