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Original article
Available online 14 January 2024
Infliximab serum concentrations in luminal Crohn's disease and its relationship with disease activity: A multicentric cross-sectional study
Concentraciones séricas de infliximab en la enfermedad de Crohn luminal y su relación con la actividad de la enfermedad: un estudio transversal multicéntrico
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Rodrigo Bremer Nonesa,
Corresponding author
robremernones@gmail.com

Corresponding author.
, Eron Fabio Mirandab, Gustavo de Nardi Marçalb, Fernanda da Silva Barbosa Baraúnab, Marcela Rocha Louresa, Paula Cenira Sengera, Daniela Oliveira Magroc, Paulo Gustavo Kotzeb
a IBD Unit, Hospital Nossa Senhora das Graças, Curitiba, Brazil
b Colorectal Surgery Unit, Pontifícia Universidade Católica do Paraná, PUCPR, Curitiba, Brazil
c Colorectal Surgery Unit, Universidade Estadual de Campinas, UNICAMP, Campinas, Brazil
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Table 1. Clinical and demographic characteristics of patients with luminal Crohn's disease in remission and general disease activity.
Table 2. Comparison between the proportions of patients in remission and different types of disease activity, according to ranges of serum IFX concentrations between 3–7μg/mL and 5–10μg/mL.
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Abstract
Objectives

In Latin America, experience with monitoring serum Infliximab (IFX) concentrations is scarce. Our study aimed to compare IFX serum concentrations between patients with active disease or in remission.

Patients and methods

A cross-sectional study was performed in patients with luminal Crohn's disease (CD) during maintenance treatment with IFX. Patients were classified as in remission or disease activity according to clinical scores and endoscopic, radiological, and laboratory markers. A comparison of IFX trough levels between the two groups was performed.

Results

80 CD patients were included [41 (51%) in remission and 39 (49%) with active disease]. In the analysis of general disease activity, the median serum levels of IFX in patients with remission and with active CD were 5.63 [0.03–14.40] vs. 3.84 [0.03–14.40] (p=0.287). Furthermore, there was no difference in serum IFX concentrations in endoscopic, radiological, and laboratory activities. Only in the clinical evaluation there was a significant difference in the median serum IFX levels between patients in remission and disease activity, 5.63 [0.03–14.40] vs. 2.14 [0.32–10.54] (p=0.042).

Conclusions

IFX serum concentrations during maintenance treatment were similar in patients with luminal CD in remission and general, endoscopic, radiological, and laboratory disease activity. Patients with clinically active disease had lower IFX concentrations than patients in remission.

Keywords:
Crohn's disease
Inflammatory bowel disease
Infliximab
Dosage
Trough level
Therapeutic drug monitoring
Resumen
Objetivos

En Latinoamérica, la experiencia en el monitoreo de las concentraciones séricas de infliximab (IFX) es escasa. Nuestro estudio tuvo como objetivo comparar las concentraciones séricas de IFX entre pacientes con enfermedad activa y remisión.

Pacientes y métodos

Se realizó un estudio transversal en pacientes con enfermedad de Crohn (EC) luminal durante el tratamiento de mantenimiento con IFX. Según una combinación de puntuaciones clínicas, marcadores endoscópicos, radiológicos y de laboratorio, los pacientes se clasificaron en remisión o actividad. Los niveles mínimos de IFX fueran determinados y comparados entre los dos grupos.

Resultados

Se incluyeron 80 pacientes con EC [41 (51%) en remisión y 39 (49%) con actividad]. En el análisis de la actividad general de la enfermedad, la mediana de los niveles séricos de IFX en pacientes con remisión y con EC activa fue 5,63 [0,03 - 14,40] vs. 3,84 [0,03 - 14,40] (p = 0,287). Además, no hubo diferencias en las concentraciones séricas de IFX en actividades endoscópicas, radiológicas y de laboratorio. Solo en la evaluación clínica hubo una diferencia significativa en los niveles séricos medios de IFX entre pacientes en remisión y actividad de la enfermedad, 5,63 [0,03 - 14,40] vs. 2,14 [0,32 - 10,54] (p =0,042).

Conclusiones

Las concentraciones séricas de IFX durante el tratamiento de mantenimiento fueron similares en pacientes con EC luminal en remisión y actividad general, endoscópica, radiológica y de laboratorio de la enfermedad. Los pacientes con enfermedad clínicamente activa tenían concentraciones de IFX más bajas que los pacientes en remisión.

Palabras clave:
Enfermedad de Crohn
Enfermedad inflamatoria intestinal
Infliximab
Dosis
Nivel mínimo
Monitoreo terapéutico de medicamentos

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