D2.214 - TAPAS – non-inferiority of clinical effectiveness in children compared to adults: 3-year interim results of a long-term NIS

The primary objective of the 5-years cohort study TAPAS (Tyrosine Allergoid Paediatric and Adult Study) is to evaluate clinical long-term effectiveness of a perennial allergen immunotherapy (AIT) with subcutaneous glutaraldehyde-modified and microcrystalline tyrosine-associated allergoids (MATA) in minors with allergic rhinitis compared to adults. All patients have finished their SCIT to date.

Patients (≥ 5 years of age) treated with MATAs for their allergy to grass or tree pollen could be included in the non-interventional study. During the 3-year treatment phase daily symptom scores and medication use during the respective pollen seasons (PS) were collected over 4 weeks via eDiary. Furthermore, severity and frequency of allergic symptoms and quality of life (RQLQ) were analyzed. Here, we present the interim data analyzed after 3 years of treatment.

129 children/adolescents and 191 adults were included with a good adherence (71% after 3^rd treatment year vs. 86% after 1^st treatment year). The primary endpoint, the mean combined symptom and medication score (CSMS) values did not differ significantly between minors and adults in the 3^rd PS which proves the non-inferiority hypothesis of clinical effectiveness (all patients, p=0.436). After the 3^rd treatment year, the median rhinitis score was significantly reduced by 50% compared to baseline in all patients (p<0.0001), the median conjunctivitis score by 60% (p<0.0001) in adults versus 80% (p<0.0001) in minors without significant difference between the age groups (p=0.185). The median asthma score significantly improved in asthmatic minors from 5 to 0 vs. adults from 4 to 0 (p<0.0001 and p=0.001, respectively). No significant differences in RQLQ were observed between adults and minors (all patients, p=0.131). Adverse drug reactions (ADRs) were reported in 21.7% of the paediatric cohort and in 12.6% of the adult cohort, however no significant difference in systemic reactions was observed between minors (7.0%) and adults (10.5%) (p=0.286).

These interim results demonstrate non-inferiority between minors and adults after 3 years SCIT with MATAs and support the common practice of using the identical dosing regimen in children and adults.