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Optimización del cambio de infliximab intravenoso intensificado a infliximab subcutáneo: un estudio de
Zhigang Wang1, Marc Ferrante2,3, Séverine Vermeire2,3
1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Journal of Crohn's & colitis
|August 28, 2025
Resumen
Los pacientes que cambian de infliximab intravenoso a infliximab subcutáneo pueden mantener la respuesta terapéutica. Este estudio muestra que el cambio a infliximab por vía subcutánea es seguro y eficaz en pacientes con enfermedad de Crohn y colitis ulcerosa.
Área de la Ciencia:
- Gastroenterología
- Farmacología
- Tratamiento clínico
Sus antecedentes:
- Existe incertidumbre con respecto a la eficacia del cambio de infliximab intravenoso intensificado (IV) a infliximab CT- P13 subcutáneo estándar (SC) (120 mg dos veces por semana).
- Este estudio aborda la relación dosis-exposición-respuesta durante este cambio de infliximab IV a SC en pacientes con enfermedad de Crohn (EC) y colitis ulcerosa (UC).
Objetivo del estudio:
- Investigar la relación dosis-exposición-respuesta de infliximab durante la transición de la administración intravenosa a la subcutánea.
- Evaluar el impacto de la activación de marcadores de respuesta terapéutica en pacientes con EC y UC.
Principales métodos:
- Se emplearon modelos farmacocinético-farmacodinámicos de población y simulación utilizando datos de estudios de fase I en los que participaron voluntarios sanos y pacientes con CD y UC.
- Se midieron la calprotectina fecal (FC), la remisión endoscópica (ER) en CD y la mejora endoscópica (EI) en UC durante el cambio de infliximab IV a SC.
- Las simulaciones incluyeron a 1,000 pacientes virtuales para evaluar los niveles de FC y las probabilidades de ER/EI después del cambio.
Principales resultados:
- La disminución de los niveles de FC se correlacionó con un aumento de la exposición general a infliximab.
- Un FC más bajo en la semana 14 predijo mayores probabilidades de EI en UC, pero no de ER en CD.
- Las simulaciones indicaron que el cambio a SC infliximab en la semana 6 mejoró la FC y aumentó la probabilidad de EI.
- Los pacientes virtuales en regímenes intensificados de mantenimiento intravenoso (hasta 10 mg/ kg Q6W/ Q8W) pudieron cambiar a 120 mg Q2W de infliximab por vía subcutánea sin aumento de la FC.
- Se desarrolló una herramienta de software clínico para guiar el cambio de infliximab IV a SC.
Conclusiones:
- Los pacientes tratados con regímenes de infliximab IV Q6W y Q8W pueden hacer la transición al infliximab SC estándar sin experimentar un aumento de la FC.
- El estudio proporciona un modelo para guiar las decisiones clínicas sobre el cambio de formulaciones de infliximab, asegurando el mantenimiento de la respuesta terapéutica.
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