The ARIETTA study: baseline demographics in a real-world setting in patients with severe asthma

Introduction and Aim: As recognition of asthma heterogeneity increases and targeted treatment options are introduced, the future role of biomarkers (BM) in patient (pt) selection, monitoring and risk prediction will be important. We report baseline demographic and clinical characteristics from ARIETTA, an ongoing, prospective, longitudinal study assessing the relationship between BM and disease-related health outcomes in the real world. Methods: Pts with severe asthma (GINA steps 4-5) receiving daily inhaled corticosteroids (CS; fluticasone propionate ≥500 μg or equivalent) and ≥1 second controller medication were enrolled. Study enrollment is now complete. BM, clinical characteristics and safety data will be collected over 52 weeks of the study. The primary endpoint is asthma exacerbation rate from baseline to week 52 in pts with high periostin (≥50 ng/mL) vs low periostin ( Results: 463 pts from 84 sites in 13 countries were enrolled and are included in the analyses; 306 (66.1%) were female. LABA, LTRA and LAMA were the most frequent second controllers, with 12.3% of pts receiving oral CS. 42.5% of pts had ≥1 exacerbation in the previous year. 51.8% had periostin ≥50 ng/mL, 33.9% had eosinophils ≥300 10 9 /L and 42.1% had FeNO ≥25 ppb. Conclusions: This study design is capturing BM phenotypes and treatment patterns in real-world pts with severe asthma who may be considered for new targeted therapies.