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Characteristics of patients receiving mepolizumab in real-world practice –REALITI-A study

Background: Mepolizumab (mepo) is an approved add-on treatment for adults with severe refractory eosinophilic asthma (SEA). Objective: To describe the real-world population of patients (pts) with SEA receiving mepo. Methods: REALITI-A is a prospective, observational, multi-country cohort study using integrated data capture methods (eCRFs, claims data, phone app). Study aims to recruit ~1,050pts with asthma, prescribed mepo 100mg SC in a clinical practice setting. Reimbursement criteria vary by country and often include the following: blood eosinophil counts (BEC; ≥150 [baseline] and/or ≥300 [prior yr] cells/µL) and 2–4 exacerbations [prior yr] or maintenance oral corticosteroid (mOCS) use. Primary objective: to compare clinically significant exacerbations (CSE; requiring OCS and/or ED visit/hospitalisation) pre-/post-mepo use. Baseline characteristics from eCRF of the initial pts are shown here. Results: By 30 Sept 2017, 170pts were enrolled (Table). Of the 137pts with a BEC, 89.8% had counts ≥150 cells/µL at baseline (Geo mean [SD log]: 436 (1.2) cells/µL) and ≥75% had ≥300 cells/µL (prior yr). In total, 85.2% and 56.1% of pts had ≥2 and ≥4 CSE in the prior yr, respectively, and 56.1% of pts had mOCS use. Conclusions: The real-world vs clinical trial population of pts with SEA receiving mepo have more frequent exacerbations in the past yr and higher BEC. This might be driven by reimbursement criteria. Funding: GSK [204710]