Eligibility for mepolizumab, omalizumab and reslizumab in the EU population: The IDEAL Study

The IDEAL study described the eligibility for biologic asthma treatment according to label criteria (omalizumab) or study protocols (mepolizumab, reslizumab).

Methods:

Post-hoc analysis of EU subjects from a cross-sectional, single-visit, observational study enrolling subjects aged ≥12yrs with severe asthma (SA) (ATS/ERS guidelines: ≥12 months high-dose ICS+ additional controller(s) treatment). Eligibility defined as: Mepolizumab: ≥2 exacerbations (corticosteroid and/or ED visit and/or hospitalization in prior 12 M) and blood eosinophil ≥150 cells/µl at Visit 1 or historically ≥300 cells/µl; Omalizumab: (EU1) ≥1 exacerbation in prior 12 M, allergic asthma, FEV₁ ≤80% pred., meeting weight and IgE criteria or (EU2) as EU1 except ≥2 exacerbation and ACQ≥1.5; Reslizumab: ≥1 exacerbation, ACQ≥1.5, airway reversibility ≥12% and blood eosinophil ≥400 cells/µl at Visit 1.

Results:

Of 292 SA patients recruited from France, Germany, and UK, 233 (80%) were included after exclusion of current omalizumab users. Of these, 56 subjects (24%) were eligible for mepolizumab; 50 (22%) and 29 (12%) for omalizumab EU1 and EU2 criteria, respectively; and 16 subjects (7%) for reslizumab. Among the 56 mepolizumab-eligible subjects, 22 (39%) and 20 (36%) were also eligible for omalizumab by EU1 or EU2 criteria and 12 (21.4%) eligible for reslizumab.

Conclusions:

In this EU-based severe asthma population not currently taking omalizumab, approximately 1/4 are mepolizumab-eligible (i.e., uncontrolled; with eosinophilic inflammation). In those mepolizumab eligible, about one third may also be eligible for omalizumab, showing that the available biologics mostly serve different SA populations. (Funded by GSK; 201722).

Abstract previously presented at ERS 2016, PA4216