Methods: This cross-sectional, single-visit, non-drug interventional study in 6 countries included subjects aged ≥12 years with severe asthma defined according to ATS/ERS guidelines by treatment with high-dose ICS plus additional controller(s) for ≥12 months. Assessments included a blood sample, spirometry, and symptom/burden of illness questionnaires.
Results: 748 subjects were enrolled, of which 670 met analysis criteria (mean age=50.5 years; 62% female). After exclusion of patients currently treated with omalizumab, 502 subjects were included in this analysis. 101 (20.1% [95% Exact CI: 16.7-23.9]) were eligible for mepolizumab and 107 (21.3% [17.8-25.2]) were eligible for omalizumab by US label criteria. 28 subjects (5.6% [3.7-8.0]) were eligible for reslizumab. Among 101 mepolizumab eligible subjects, 37 (36.6% [27.3-46.8]) were also eligible for omalizumab and 18 (17.8% [10.9-26.7]) for reslizumab.
Conclusions: In this severe asthma population defined by high-dose ICS use plus a controller(s) not currently taking omalizumab, one-fifth are mepolizumab-eligible (i.e., uncontrolled with eosinophilic inflammation). In those mepolizumab eligible subjects, about one-third may also be eligible for omalizumab; this is equivalent to 7.4% of the severe asthma patient population not currently treated with omalizumab. These data highlight a high unmet need in this uncontrolled population that is currently underserved by existing therapies. (Funded by GSK; 201722/NCT02293265)