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:


  • 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.


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


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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