Rationale Severe asthma is a heterogeneous disease in which patients have diverse clinical characteristics and biomarkers, like eosinophils and IgE. It is important to understand their relationship in a severe asthma population. The IDEAL (Identification and Description of Severe Asthma Patients in a Cross-Sectional Study) study aimed to identify the proportion of patients with severe asthma who could be eligible for an anti IL-5 (mepolizumab) or anti-IgE (omalizumab) directed treatment, and those who may be eligible for either therapy.
Methods IDEAL, an observational study 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 spirometry, a blood sample, and symptom/burden of illness questionnaires. Eligibility to mepolizumab and omalizumab were defined according to SMC advice (2016) and NICE MTA guidance (2013), which has been adopted in Scotland, respectively. Mepolizumab eligibility is defined as per SMC advice: patients who have eosinophils of at least 150 cells per microlitre (0.15 x 109/L) at initiation of treatment and have had at least four asthma exacerbations in the preceding year or are receiving maintenance treatment with oral corticosteroids. Omalizumab eligibility (NICE MTA guidance) is defined as evidence of severe persistent allergic asthma and need for continuous or frequent treatment with oral corticosteroids (defined as 4 or more courses in the previous year), and meeting bodyweight and IgE criteria for omalizumab treatment.
Results 748 subjects with severe asthma were enrolled in the study of which 670 met analysis criteria. After exclusion of subjects currently treated with omalizumab (n = 168), 502 subjects were included in this post-hoc analysis (mean age = 50.9 years; 62% female). 60 subjects (12% [95% Exact CI: 9.2–15.1%]) were eligible for mepolizumab (SMC advice) and 16 (3.2% [1.8–5.1]) were eligible for omalizumab (NICE MTA guidance). Among the 60 mepolizumab eligible subjects, 10 (16.7% [8.3–28.5%]) were also eligible for omalizumab.
Conclusions This is the first cross-sectional study providing estimation of the proportion of severe asthma patients eligible for biologic therapy in accordance with Scottish guidance, indicating 12% mepolizumab-eligible and 3.2% omalizumab-eligible patients with limited overlap.
Funding GSK; 201722
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