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Infliximab de mantenimiento para la enfermedad de Crohn: el ensayo aleatorizado ACCENT I

Stephen B Hanauer¹, Brian G Feagan, Gary R Lichtenstein

¹Department of Gastroenterology and Nutrition, University of Chicago Medical Center, Chicago, IL 60637, USA. shanauer@medicien.bsd.uchicago.edu

Lancet (London, England)

|June 6, 2002

Resumen

La terapia de mantenimiento con infliximab mejora significativamente las tasas de remisión y prolonga la respuesta en pacientes con enfermedad de Crohn. El tratamiento continuado cada 8 semanas es más efectivo que el placebo para la remisión clínica sostenida.

Área de la Ciencia:

Gastroenterología y Gastroenterología.
Inmunología Inmunología.
Farmacología clínica Farmacología clínica.

Sus antecedentes:

La enfermedad de Crohn es una enfermedad inflamatoria intestinal crónica.
Infliximab es una terapia biológica utilizada para la enfermedad de Crohn.
La evaluación de las estrategias de dosificación óptimas de infliximab es crucial para el manejo del paciente.

Objetivo del estudio:

Evaluar la eficacia de la terapia de mantenimiento con infliximab en pacientes con enfermedad de Crohn activa que inicialmente respondieron al tratamiento.
Para comparar diferentes esquemas de reinfusión de infliximab con el placebo.
Para determinar el impacto de la terapia de mantenimiento en la remisión clínica y el tiempo hasta la pérdida de respuesta.

Principales métodos:

Un ensayo controlado aleatorizado en el que participaron 573 pacientes con enfermedad de Crohn activa (puntuación CDAI ≥220).
Los pacientes recibieron una infusión inicial de infliximab, seguida de una aleatorización a placebo, terapia de mantenimiento de infliximab en dosis estándar o escaladas.
Los parámetros de valoración coprimarios incluyeron la remisión en la semana 30 y el tiempo hasta la pérdida de respuesta hasta la semana 54, analizados por intención de tratar.

Principales resultados:

El 58% de los pacientes respondieron a la infusión inicial de infliximab.
Se observaron tasas de remisión significativamente más altas en la semana 30 en los grupos de mantenimiento de infliximab (39-45%) en comparación con el placebo (21%).
El infliximab de mantenimiento prolongó significativamente el tiempo hasta la pérdida de respuesta (mediana >54 semanas) en comparación con el placebo (19 semanas).

Conclusiones:

La terapia de mantenimiento con infliximab, administrada cada 8 semanas, es efectiva para mantener la remisión clínica en pacientes con enfermedad de Crohn que responden al tratamiento inicial.
La continuación del tratamiento con infliximab conduce a respuestas más duraderas y apoya la interrupción del tratamiento con corticosteroides.
El perfil de seguridad del infliximab de mantenimiento fue consistente con estudios anteriores, con tasas similares de infecciones graves en todos los grupos.

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