TRATAMIENTO BIOLÓGICO DE LAS ALERGIAS

 

El uso de fármacos biológicos en alergia ha cambiado drásticamente el tratamiento de las enfermedades alérgicas. Los anticuerpos monoclonales se incluyen dentro del grupo de fármacos biológicos o biotecnológicos porque contienen uno a más principios activos sintetizados a partir de una fuente biológica.

En las enfermedades alérgicas, las citocinas tienen un papel fundamental en las características clínicas observadas, por ejemplo, eosinofilia, elevación de IgE, hipersecreción de moco e hiperreactividad bronquial. Por ello, las moléculas diana que se han estudiado hasta la fecha son: IgE, IL-5 y su receptor (IL-5Rα), el receptor de IL-4 (IL-4Rα) y están avanzados estudios con biológicos frente a IL-13 e IL-9.

En la actualidad sólo existen 5 fármacos biológicos en alergia aprobados por la EMA (en asma, dermatitis, urticaria; desglosado a continuación), con ensayos clínicos en curso para su aprobación en alergia alimentaria y rinitis alérgica.

Anticuerpo Monoclonal Blanco Tipo Año aprobación EMA Indicaciones terapéuticas
Benralizumab IL-5Rα Humanizado IgG1 2019 Asma alérgica eosinofílica
Dupilumab IL-4Rα Humano IgG4 2019 Asma alérgica eosinofílica; dermatitis atópica
Reslizumab IL-5 Humanizado IgG4 2016 Asma alérgica eosinofílica
Mepolizumab IL-5 Humanizado IgG1 2015 Asma alérgica eosinofílica
Omalizumab IgE Humanizado IgG1 2005 Asma alérgica mediada por IgE; urticaria crónica espontánea

Fármacos biológicos en alergia aprobados actualmente por la EMA:

Omalizumab

  • A) Asma bronquial alérgica grave, como terapia complementaria en adultos y niños mayores de 6 años con asma alérgica mediada por IgE, persistente o no controlada. La dosis y la frecuencia de administración de Omalizumab se determinan a partir de la concentración basal de IgE sérica total, medida antes de iniciar el tratamiento, y del peso corporal.

Se recomienda que la IgE sérica esté por encima de 76 UI/ml en adultos y adolescentes y en niños (6-12 años de edad) por encima de 200 UI/ml, para aumentar la probabilidad de beneficio. En las guías de práctica clínica, se recomienda una IgE sérica comprendida entre 30-1.500 UI/ml.

  • B) Urticaria crónica espontánea, en pacientes adultos y adolescentes (a partir de 12 años) con respuesta inadecuada al tratamiento con antihistamínicos. La dosis apropiada de administración de Omalizumab es independiente de la concentración basal de IgE: 300 mg cada cuatro semanas.

 

 

Mepolizumab y Reslizumab

Tratamiento adicional en adultos con asma eosinofílica refractaria grave. Mepolizumab se administra por vía subcutánea mientras que Reslizumab se administra por vía intravenosa, ambos cada 4 semanas.

Benralizumab

Tratamiento de mantenimiento adicional en adultos con asma grave eosinofílica. Se administra por vía subcutánea cada 4-8 semanas.

Dupilumab

Tratamiento de la dermatitis atópica moderada a grave en pacientes adultos candidatos a tratamiento sistémico. No está aún registrado para el tratamiento del asma. Dupilumab se administra por vía subcutánea cada 2 semanas.

 

 

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