The Identification and Description of Severe Asthma Patients in a Cross-Sectional Study—the Ideal Study
Sunday, March 6, 2016
South Exhibit Hall H (Convention Center)
Robert Y. Suruki, Sc.D., Necdet Gunsoy, Ph.D., Ji-Yeon Shin, Jonas Daugherty, Linda Nelsen, Eric Bradford, M.D., Frank C. Albers, M.D., Ph.D.
Rationale: Studies have shown that mepolizumab (anti-IL5), reslizumab (anti-IL5), and omalizumab (anti-IgE) are effective treatments for asthma in patients with overlapping phenotypic characteristics. The IDEAL study described the eligibility for treatment with these biologics for asthma according to label criteria or study protocols that will form the basis for approved labeling.

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)