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Tratamiento de aumento intravenoso y densidad pulmonar en deficiencia severa de antitripsina α1 (RAPID): un ensayo

Kenneth R Chapman¹, Jonathan G W Burdon², Eeva Piitulainen³

¹Asthma and Airway Centre, University Health Network, Toronto Western Hospital, and Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.

Lancet (London, England)

|June 1, 2015

Resumen

El tratamiento de aumento con inhibidor de la alfa1 proteinasa (A1PI) ralentiza la progresión del enfisema en pacientes con deficiencia de antitripsina alfa1. Este hallazgo, basado en la densidad pulmonar CT a la capacidad pulmonar total, apoya la terapia A1PI para preservar el tejido pulmonar.

Área de la Ciencia:

Pulmonología Pulmonología.
Radiología Radiología.
Farmacología Farmacología.

Sus antecedentes:

La deficiencia de antitripsina alfa1 (AATD) es un trastorno genético que conduce al enfisema pulmonar.
Faltan ensayos aleatorizados controlados con placebo que sustenten la eficacia del aumento de A1PI.
La densidad pulmonar medida por TC es un marcador sensible para la progresión del enfisema AATD.

Objetivo del estudio:

Para evaluar la eficacia de la terapia de aumento del inhibidor de la alfa1 proteinasa (A1PI) en AATD.
Para utilizar la densidad pulmonar evaluada por TC como la medida de resultado principal.
Para llevar a cabo un ensayo riguroso, aleatorizado y controlado con placebo (estudio RAPID).

Principales métodos:

Un ensayo multicéntrico, doble ciego, aleatorizado y controlado con placebo que involucró a 180 pacientes con TEAA grave.
Los pacientes recibieron A1PI por vía intravenosa (60 mg/kg/semana) o placebo durante 24 meses.
Endpoint primario: cambios en la densidad pulmonar CT en la capacidad pulmonar total (TLC) y la capacidad residual funcional (FRC) combinada y por separado.

Principales resultados:

El tratamiento con A1PI no alteró significativamente la pérdida de densidad pulmonar cuando se combinaron las mediciones de TLC y FRC (p=0,06).
Sin embargo, A1PI redujo significativamente la tasa de pérdida de densidad pulmonar en TLC solo (diferencia de 0.74 g/L por año, p=0.03).
Los eventos adversos fueron similares entre los grupos A1PI y placebo; A1PI fue bien tolerado.

Conclusiones:

La medición de la densidad pulmonar CT en TLC solo demuestra que la terapia de aumento de A1PI ralentiza la progresión del enfisema en AATD.
Este hallazgo apoya la consideración del aumento de A1PI para preservar el parénquima pulmonar en el enfisema relacionado con AATD.
La densidad pulmonar en el FRC solo o las mediciones combinadas no mostraron diferencias significativas.

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