<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1699-714X</journal-id>
<journal-title><![CDATA[Revista de la OFIL ]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. OFIL·ILAPHAR]]></abbrev-journal-title>
<issn>1699-714X</issn>
<publisher>
<publisher-name><![CDATA[Organización de Farmacéuticos Ibero-Latinoamericanos]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1699-714X2020000400016</article-id>
<article-id pub-id-type="doi">10.4321/s1699-714x2020000400016</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Monitorización farmacocinética de niveles supraterapéuticos de adalimumab en paciente con enfermedad de Crohn]]></article-title>
<article-title xml:lang="en"><![CDATA[Pharmacokinetic monitoring of supratherapeutic adalimumab levels in patient with Crohn's disease]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Alañón Pardo]]></surname>
<given-names><![CDATA[MM]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Proy Vega]]></surname>
<given-names><![CDATA[B]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Roncero García-Escribano]]></surname>
<given-names><![CDATA[O]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Valenzuela Gámez]]></surname>
<given-names><![CDATA[JC]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Hospital General La Mancha-Centro Servicio de Farmacia ]]></institution>
<addr-line><![CDATA[Alcázar de San Juan Ciudad Real]]></addr-line>
<country>España</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Hospital General La Mancha-Centro Servicio de Digestivo ]]></institution>
<addr-line><![CDATA[Alcázar de San Juan Ciudad Real]]></addr-line>
<country>España</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2020</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2020</year>
</pub-date>
<volume>30</volume>
<numero>4</numero>
<fpage>347</fpage>
<lpage>350</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S1699-714X2020000400016&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S1699-714X2020000400016&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S1699-714X2020000400016&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN La monitorización farmacocinética de terapias biológicas dirigidas frente al factor de necrosis tumoral-a (TNF-a) ha sido recientemente introducida en nuestro centro hospitalario gracias a la iniciativa de nuestro equipo de enfermedad inflamatoria intestinal, formado por farmacéuticos, digestólogos y analistas clínicos, con la finalidad de optimizar la terapia en los pacientes que se mantienen en remisión clínica (monitorización &#8220;pro-activa&#8221;), o que presentan un fracaso terapéutico (monitorización &#8220;re-activa&#8221;). Se presenta un caso clínico de una paciente diagnosticada de enfermedad de Crohn y en tratamiento combinado con metotrexato y adalimumab. En septiembre de 2018, adalimumab fue intensificado de forma empírica a dosis de 40 mg administrados semanalmente por la aparición de manifestaciones extradigestivas (artralgias y parestesias en miembros inferiores). En febrero de 2019, la paciente se mantenía en remisión clínica con respecto a los síntomas intestinales, pero continuaba con las manifestaciones extradigestivas y refería aftas orales recurrentes. Por este motivo, se monitorizaron los niveles séricos de adalimumab, los cuales superaron ampliamente el intervalo terapéutico recomendado (5-12 µg/ml). En este sentido, se describe el seguimiento multidisciplinar del caso clínico y el ajuste posológico realizado en base a predicciones bayesianas, principios farmacocinéticos y farmacodinámicos y la clínica de la paciente. La monitorización farmacocinética de los niveles supraterapéuticos de adalimumab fue una herramienta útil para la optimización de dosis de adalimumab y la valoración objetiva de reacciones adversas en esta paciente. Este caso se ha notificado al Sistema Español de Farmacovigilancia.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[SUMMARY The pharmacokinetic monitoring of biological therapies against tumor necrosis-a (TNF-a) was recently introduced at our hospital thanks to the initiative of our inflammatory bowel disease team, composed of specialists in pharmacology, digestive system disease, and clinical analysis. The aim of the program was to optimize the therapy delivered to patients in clinical remission (pro-active monitoring) or clinical failure (reactive monitoring). We report the case of a patient diagnosed with Crohn&#8217;s disease and under combined treatment with methotrexate and adalimumab. In September 2018, the dose of adalimumab was empirically increased to 40 mg/week due to the onset of extraintestinal manifestations (arthralgias and paraesthesias in lower limbs). In February 2019, the patient was in clinical remission with respect to the intestinal symptoms, but the extraintestinal manifestations persisted and the patient also reported anal aphthae. Consequently, serum adalimumab concentrations were monitored and found to widely exceed the recommended therapeutic interval (5-12 µg/ml). We report the multidisciplinary follow-up of the clinical case and the dosage adjustment based on Bayesian predictions, pharmacokinetic and pharmacodynamic principles, and the patient&#8217;s clinical situation. Pharmacokinetic monitoring of supratherapeutic adalimumab levels proved to be a useful tool to achieve the optimal dosage of this drug and to objectively evaluate the patient&#8217;s adverse reactions. The Spanish Pharmacosurveillance System has been notified of this case.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Monitorización farmacocinética]]></kwd>
<kwd lng="es"><![CDATA[adalimumab]]></kwd>
<kwd lng="es"><![CDATA[enfermedad inflamatoria intestinal]]></kwd>
<kwd lng="en"><![CDATA[Therapeutic drug monitoring]]></kwd>
<kwd lng="en"><![CDATA[adalimumab]]></kwd>
<kwd lng="en"><![CDATA[chronic inflammatory diseases]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Mitrev]]></surname>
<given-names><![CDATA[N]]></given-names>
</name>
<name>
<surname><![CDATA[Vande Casteele]]></surname>
<given-names><![CDATA[N]]></given-names>
</name>
<name>
<surname><![CDATA[Seow]]></surname>
<given-names><![CDATA[CH]]></given-names>
</name>
<name>
<surname><![CDATA[Andrews]]></surname>
<given-names><![CDATA[JM]]></given-names>
</name>
<name>
<surname><![CDATA[Connor]]></surname>
<given-names><![CDATA[SJ]]></given-names>
</name>
<name>
<surname><![CDATA[Moore]]></surname>
<given-names><![CDATA[GT]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases]]></article-title>
<source><![CDATA[Aliment Pharmacol Ther]]></source>
<year>2017</year>
<volume>46</volume>
<page-range>1037-53</page-range></nlm-citation>
</ref>
<ref id="B2">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Khan]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Berahmana]]></surname>
<given-names><![CDATA[AB]]></given-names>
</name>
<name>
<surname><![CDATA[Day]]></surname>
<given-names><![CDATA[AS]]></given-names>
</name>
<name>
<surname><![CDATA[Barclay]]></surname>
<given-names><![CDATA[ML]]></given-names>
</name>
<name>
<surname><![CDATA[Schultz]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[New Zealand Society of Gastroenterology Guidelines on Therapeutic Drug Monitoring in Inflammatory Bowel Disease]]></article-title>
<source><![CDATA[N Z Med J]]></source>
<year>2019</year>
<volume>132</volume>
<page-range>46-62.</page-range></nlm-citation>
</ref>
<ref id="B3">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Sanchez-Hernandez]]></surname>
<given-names><![CDATA[JG]]></given-names>
</name>
<name>
<surname><![CDATA[Rebollo]]></surname>
<given-names><![CDATA[N]]></given-names>
</name>
<name>
<surname><![CDATA[Muñoz]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[Martín Suárez]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Calvo]]></surname>
<given-names><![CDATA[MV]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Therapeutic drug monitoring of tumour necrosis factor inhibitors in the management of chronic inflammatory diseases]]></article-title>
<source><![CDATA[Ann Clin Biochem]]></source>
<year>2019</year>
<volume>56</volume>
<page-range>28-41</page-range></nlm-citation>
</ref>
<ref id="B4">
<nlm-citation citation-type="">
<collab>European Medicines Agency</collab>
<source><![CDATA[Ficha Técnica de Adalimumab (Humira®)]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B5">
<nlm-citation citation-type="confpro">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Sánchez-Hernandez]]></surname>
<given-names><![CDATA[JG]]></given-names>
</name>
<name>
<surname><![CDATA[Rebollo Díaz]]></surname>
<given-names><![CDATA[N]]></given-names>
</name>
<name>
<surname><![CDATA[Sáez Fernández]]></surname>
<given-names><![CDATA[EM]]></given-names>
</name>
<name>
<surname><![CDATA[Piñero Pérez]]></surname>
<given-names><![CDATA[MC]]></given-names>
</name>
<name>
<surname><![CDATA[Pedraza Nieto]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
<name>
<surname><![CDATA[Fernández Caballero]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
</person-group>
<source><![CDATA[Influencia del índice de masa corporal en la dosificación de adalimumab en enfermedad inflamatoria intestinal]]></source>
<year>2018</year>
<conf-name><![CDATA[ 63 Congreso Nacional de la Sociedad Española de Farmacia Hospitalaria]]></conf-name>
<conf-loc> </conf-loc>
</nlm-citation>
</ref>
<ref id="B6">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Berends]]></surname>
<given-names><![CDATA[SE]]></given-names>
</name>
<name>
<surname><![CDATA[Strik]]></surname>
<given-names><![CDATA[AS]]></given-names>
</name>
<name>
<surname><![CDATA[Van Selm]]></surname>
<given-names><![CDATA[JC]]></given-names>
</name>
<name>
<surname><![CDATA[Lowenberg]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Ponsioen]]></surname>
<given-names><![CDATA[CY]]></given-names>
</name>
<name>
<surname><![CDATA[D&#8217;Haens]]></surname>
<given-names><![CDATA[GR]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Explaining interpatient variability in adalimumab Pharmacokinetics in patients with Crohn&#8217;s Disease]]></article-title>
<source><![CDATA[Ther Drug Monit]]></source>
<year>2018</year>
<volume>40</volume>
<page-range>202-11</page-range></nlm-citation>
</ref>
<ref id="B7">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Naranjo]]></surname>
<given-names><![CDATA[CA]]></given-names>
</name>
<name>
<surname><![CDATA[Busto]]></surname>
<given-names><![CDATA[U]]></given-names>
</name>
<name>
<surname><![CDATA[Sellers]]></surname>
<given-names><![CDATA[EM]]></given-names>
</name>
<name>
<surname><![CDATA[Sandor]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
<name>
<surname><![CDATA[Ruiz]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
<name>
<surname><![CDATA[Roberts]]></surname>
<given-names><![CDATA[EA]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[A method for estimating the probability of adverse drug reactions]]></article-title>
<source><![CDATA[Clin Pharmacol Ther]]></source>
<year>1981</year>
<volume>30</volume>
<page-range>239-45</page-range></nlm-citation>
</ref>
<ref id="B8">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Kaltsonoudis]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[Zikou]]></surname>
<given-names><![CDATA[AK]]></given-names>
</name>
<name>
<surname><![CDATA[Voulgari]]></surname>
<given-names><![CDATA[PV]]></given-names>
</name>
<name>
<surname><![CDATA[Konitsiotis]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Argyropoulou]]></surname>
<given-names><![CDATA[MI]]></given-names>
</name>
<name>
<surname><![CDATA[Drosos]]></surname>
<given-names><![CDATA[AA]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Neurological adverse events in patients receiving an anti-TNF therapy: a prospective imaging and electrophysiological study]]></article-title>
<source><![CDATA[Arhritis Res Ther]]></source>
<year>2014</year>
</nlm-citation>
</ref>
<ref id="B9">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Tejera-Segura]]></surname>
<given-names><![CDATA[B]]></given-names>
</name>
<name>
<surname><![CDATA[Ferraz-Amaro]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Biological therapy and neurological manifestations. What do we know?]]></article-title>
<source><![CDATA[Reumatol Clin]]></source>
<year>2017</year>
<volume>13</volume>
<page-range>102-6</page-range></nlm-citation>
</ref>
<ref id="B10">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Kemanetzoglou]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[Andreadou]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[CNS Demyelination with TNF-&#593;Blockers.]]></article-title>
<source><![CDATA[Curr Neurol Neurosci Rep]]></source>
<year>2017</year>
<volume>17</volume>
<page-range>36</page-range></nlm-citation>
</ref>
</ref-list>
</back>
</article>
