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Inicio Medicina Clínica Definition of a therapeutic range for predicting long-term infliximab response i...
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Vol. 160. Issue 3.
Pages 107-112 (February 2023)
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Vol. 160. Issue 3.
Pages 107-112 (February 2023)
Original article
Definition of a therapeutic range for predicting long-term infliximab response in patients with inflammatory bowel disease
Definición de un rango terapéutico para predecir la respuesta al infliximab a largo plazo en pacientes con enfermedad inflamatoria intestinal
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Lorenzo Cantarellia,
Corresponding author
Lorenzo.adeje@gmail.com

Corresponding author.
, Marta Carrillo Palaub, Manuel Hernandez Guerrab, Gloria Julia Nazco Casariegoa, Fernando Gutierrez Nicolása
a Servicio de Farmacia. Complejo Hospitalario Universitario de Canarias, Tenerife, Spain
b Servicio de Aparato Digestivo, Complejo Hospitalario Universitario de Canarias, Tenerife, Spain
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Abstract
Introduction

Monitoring plasma levels of Infliximab plays an important role in optimising treatment in patients with inflammatory bowel disease (IBD). The aim of the following study has been to determine the predictive potential of monitoring infliximab plasma levels for sustained clinical response and evaluate its usefulness to improve treatment efficacy and symptom control, in patients with IBD.

Methods

This single-centre retrospective study (2017–2019) included patients diagnosed with IBD treated with infliximab. Serum levels and the occurrence of drug-associated immunogenicity were analysed at Week 8 post-induction and 6, 12 and 24 months. Clinical parameters and inflammatory markers were recorded such as subjective global assessment (SGA), C-reactive protein (CRP) and faecal calprotectin (FC). Factors associated with early discontinuation and dose intensification of infliximab were determined.

Results

Multivariate analysis determined that IFX concentrations>7μg/mL at week 8, and at 6 months, are associated with inflammatory remission (p=0.046, 0.045). IFX>7μg/mL at 12 months predicted remission at 18 months of treatment (p=0.006). IFX values>3μg/mL at 12 months are associated with stable SGA at 18 months (p=0.001). Such values at 18 months are associated with stable SGA at 24 months (p=0.044).

Conclusions and relevance

The predictive potential of monitoring IFX plasma levels as a strategy to evaluate sustained long-term clinical response was confirmed. Our results highlight the importance of its introduction into routine clinical practice to enable early identification of non-responders, treatment optimisation, relapse prevention and improve long-term therapy maintenance.

Keywords:
Infliximab
Ulcerative colitis
Crohn's disease
Pharmacokinetics
Inflammatory bowel disease
Resumen
Introducción

La monitorización de infliximab (IFX) juega un papel importante en la optimización del tratamiento en pacientes con enfermedad inflamatoria intestinal (EII). El objetivo del estudio fue determinar el potencial predictivo de la monitorización de IFX para la respuesta clínica sostenida, y evaluar su utilidad en la eficacia del tratamiento y del control de los síntomas.

Métodos

Estudio retrospectivo unicéntrico (2017-2019) que incluyó pacientes con EII tratados con IFX. Se analizaron los niveles séricos y la inmunogenicidad asociada al fármaco en la semana 8 postinducción, y a los 6, 12 y 24 meses. Se registraron los parámetros clínicos y los marcadores inflamatorios correspondientes a la evaluación global subjetiva (SGA), proteína C reactiva (PCR) y calprotectina fecal (CF). Se determinaron los factores asociados a la interrupción precoz y a la intensificación de la dosis de IFX.

Resultados

El análisis multivariante determinó que las concentraciones de IFX>7μg/ml en la semana 8, y a los 6 meses, se asocian a la remisión inflamatoria (p=0,046-0,045). El IFX>7μg/ml a los 12 meses predijo la remisión a los 18 meses de tratamiento (p=0,006). Los valores de IFX>3μg/ml a los 12 meses se asocian a una SGA estable a los 18 meses (p=0,001). Dichos valores a los 18 meses se asocian a SGA estable a los 24 meses (p=0,044).

Conclusiones y relevancia

Se confirma el potencial predictivo de la monitorización de los niveles plasmáticos de IFX como estrategia para evaluar la respuesta clínica sostenida a largo plazo. Nuestros resultados destacan la importancia de su introducción en la práctica clínica habitual para permitir la identificación temprana de los no respondedores, la optimización del tratamiento, la prevención de recaídas y mejorar el mantenimiento de la terapia a largo plazo.

Palabras clave:
Infliximab
Colitis ulcerosa
Enfermedad de Crohn
Farmacocinética
Enfermedad inflamatoria intestinal

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