Immunological measures as potential markers of dose.

ABSTRACT

Specific immunotherapy (SIT) induces immunological changes leading to a decrease in allergen-driven symptoms and medication use. However, the use of arbitrary and variable assay formats and units hampers comparisons between SIT studies. The magnitude of IgG response induced by SIT is not directly linked to clinical improvement, so an increase in allergen-specific IgG(4) should be considered a necessary but not sufficient marker of clinical efficacy. Dose-dependent IgG(4) immune responses should be demonstrated by the manufacturer, not by doctors. Symptom and medication scores are essential end-points for immunotherapy studies, but are subjective, so close association with objective assay measurements will be difficult. Nonetheless, blocking antibody assays combining serology and cellular function may provide a solution for relating immunological assay measurements to clinical outcomes.