D2.215 - A Prospective Long-Term Cohort Study with Seasonal Allergic Rhinitis (TAPAS) with MATAs in tree- and grass-allergic patients

Aim of the 5-years cohort study TAPAS (Tyrosine Allergoid Paediatric and Adult Study) is to investigate the clinical long-term effectiveness of a perennial subcutaneous allergen immunotherapy (SCIT) with glutaraldehyde-modified and microcrystalline tyrosine-associated allergoids (MATAs) in patients with allergic rhinitis. All patients have finished their SCIT to date.

Patients (≥ 5 years of age) treated with MATAs for their allergy to grass or birch, alder & hazel pollen could be included in the non-interventional study prior starting SCIT. During the treatment phase (3 years) daily symptom scores and medication use during the respective pollen seasons (PS) were collected over 4 weeks using an eDiary. At start and during the study, patients retrospectively reported about severity and frequency of their allergic/asthma symptoms and Quality of Life (RQLQ) was analyzed.

320 patients (129 children/adolescents, 191 adults, age: 5-75 years) were included, adherence was at 71% after 3^rd treatment year. The mean combined symptom and medication score (CSMS, primary endpoint) was significantly decreased during the 3^rd PS compared to the 1^st PS (p=0.021). The median rhinitis score was significantly reduced by 50% after 3 years of SCIT compared to baseline in all patients (p<0.0001), in grass patients (-50%, p<0.0001) and tree patients (-50%, p<0.0001). Results for the conjunctivitis score were reduced accordingly (all patients: -60%, grass patients: -60%, tree patients: -80%, p<0.0001). The asthma score significantly improved in all groups (all-, grass- and tree patients: -100%, p<0.0001) after 3 years of treatment. Moreover, Quality of life has improved during therapy, the median RQLQ score was reduced during the 3^rd PS compared to the 1^st PS. The occurrence of adverse drug reactions (ADRs) decreased during therapy course from year 1 to year 3. During 3 years of SCIT non-serious ADRs were reported in 52 patients (16.3%), serious ADRs in 2 patients. Systemic reactions were observed in 9.1% and local reactions in 12.8% of patients without differences between grass- and tree-allergic patients.

These interim results demonstrate that 3-year SCIT with MATAs is an effective and safe therapeutic option for patients from 5 years onwards with allergic rhinitis against tree and grass pollen.