RATIONALE: Fast dissolving tablets for sublingual allergen immunotherapy (SLIT) are now globally available and cover the three major allergies grass, house dust mite and ragweed. This allows for comparative evaluation of immunological responses to treatment on a global scale across SLIT-tablet development programs. METHODS: Data collected during 8 placebo-controlled phase III studies covering 2509 patients was used for analysis. In all trials, allergen-specific IgE and IgG4 (sIgE and sIgG4) were measured using ImmunoCAP. Active treatment comprised fast-dissolving Zydis-formulation (SLIT-tablets) for allergic rhinitis and/or allergic asthma due to the following allergens: house dust mite (4 trials), grass (2 trials), and ragweed (2 trials). RESULTS: Across trials and allergens, active treatment groups show comparable levels of changes in immunological responses of sIgE and sIgG4. For all trials, the largest average increase in sIgE was observed within the first three months whereas sIgG4 continuously increased during the first year of treatment. For placebo-treated patients, a minor increase in antibody titers in relevant pollen seasons was observed. Looking at individual measurements, consistency was further demonstrated by similar distribution profiles of changes in sIgE and sIgG4 during the early and late phase of treatment, respectively. CONCLUSIONS: During the first year and across trials, changes in sIgE and sIgG4 demonstrate a high level of similarity despite underlying heterogeneity in enrolled patients, tablet treatments and geographical location including Europe, North America and Japan. This indicates a common immunological mechanism for the entire class of fast-dissolving SLIT-tablets.

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