D2.175 - TAPAS – non-inferiority of clinical effectiveness in children compared to adults: interim results of a long-term NIS

The primary objective of TAPAS (Tyrosine Allergoid Paediatric and Adult Study) is to evaluate clinical long-term effectiveness of a perennial allergen immunotherapy (AIT) with subcutaneous glutaraldehyde-modified & microcrystalline tyrosine-associated allergoids (MATA) in children compared to adults suffering from allergic rhinitis, as an identical dosing regimen is used.

Patients ≥ 5 years who were treated with MATAs for their allergy to grass or birch, alder & hazel pollen could be included in the NIS prior starting AIT. During the treatment phase (3 y) daily symptom scores & medication usage during the respective pollen seasons were collected over 4 weeks via eDiary. Furthermore, at start & during the study, patients retrospectively reported about severity & frequency of their allergic/asthma symptoms. Here, we present the interim data analyzed after 1 treatment year.

129 children/adolescents & 191 adults were included with a good adherence after 1 year of treatment (86%). The primary endpoint, the combined symptom and medication score (CSMS), showed no significant difference between adults & children/adolescents which proves the non-inferiority hypothesis of clinical effectiveness.

The rhinoconjunctivitis score was significantly reduced by 25% after 1 year of AIT compared to baseline in all patients (-1.0 score points, p<0.001) & in grass patients (-2.0, 40%, p<0.001) & tree patients (-1.0, 25%, p<0.001) with no significant differences between children/adolescents & adults (total p=0.374, grass p=0.599; tree p=0.888). The results for the conjunctivitis & rhinitis score were reduced accordingly. The asthma score significantly improved in asthmatic children/adolescents (grass: -2.5, 100%, p<0.001; tree: -3.0, 100%, p<0.05) & adults (grass: -2.0, 56%, p<0.001; tree: -2.0, 100%, p<0.001) after 1 year of AIT.

Adverse drug reactions were reported in 21.7% of the paediatric cohort & in 12 % of the adult cohort, however no difference in systemic reactions was observed between children/adolescents (7.8%) and adults (7.33%) (p=0.888).

The interim results of the TAPAS study demonstrate non-inferiority between children & adults after 1 year AIT with MATA & support the common practice of using the identical dosing regimen in children & adults. Significant clinical improvements could be shown already after 1 year with a good tolerability of AIT in children and support the excellent safety profile of subcutaneous AIT with MATA.