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The Arietta Study: Exploring Severe Asthma Biomarkers in a Real-World Setting
Monday, March 7, 2016
South Exhibit Hall H (Convention Center)
Nicola A. Hanania, MD, Stephanie Korn, Andrew Menzies-Gow, Michel Aubier, Kenneth R. Chapman, Giorgio Walter Canonica, MD, Cesar Picado, MD, PhD, Nicolas Martin, Ramón A Escobar, Stephan Korom, Roland Buhl
Rationale: As the heterogeneity of asthma is increasingly recognized, and targeted treatment options emerge, the role of asthma biomarkers in patient selection, monitoring and risk-prediction will be important. However, the prognostic value of these biomarkers in a real-world clinical setting remains unknown. Here, we outline the design of a multicenter, prospective, longitudinal non-interventional study that aims to assess the relationship between biomarkers and asthma-related health outcomes in a real-world setting. 

Methods: The study will enroll ~1200 adult patients with severe asthma (GINA steps 4–5) from ~160 sites in 21 countries, who will have regular follow-ups over 52 weeks (NCT02537691). Enrollment criteria include adults with asthma requiring daily inhaled corticosteroid (≥500 µg fluticasone propionate or equivalent) and ≥1 second controller. Key biomarkers assessed include FeNO, serum periostin, blood eosinophil count and serum IgE. Data on pulmonary function, symptoms and quality of life, exacerbations, asthma-related healthcare utilization and safety events will also be collected. During the study, patients’ treatment regimens are not pre-specified. The primary outcome is the rate of asthma exacerbations from baseline to Week 52 in patients with high periostin levels (≥50 ng/mL) compared with those with low levels (<50 ng/mL). Secondary analyses will examine the longitudinal relationship between different asthma biomarkers and clinical outcomes.

Results: The first patient was enrolled in August 2015. Data is expected to be available in 2018.

Conclusions: This unique real-world study will address crucial unanswered questions regarding asthma biomarkers, their prognostic value, and ultimately help guide clinicians to a more targeted therapeutic approach to severe asthma.