Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study

Abstract

Objectives: Severe asthma comprises several distinct phenotypes. Consequently, patients with severe asthma can be eligible for more than one biologic treatment targeting Th2 inflammation, such as anti-interleukin (IL)-5 and anti-immunoglobulin (Ig) E. The objective of this study was to describe treatment eligibility and overlap in treatment eligibility for mepolizumab (anti-IL-5), omalizumab (anti-IgE) and reslizumab (anti-IL-5) in patients with severe asthma, who were recruited from clinical practice. Methods: This cross-sectional, single-visit, observational study in six countries enrolled patients with severe asthma (defined by American Thoracic Society/European Respiratory Society guidelines). Assessable patients were analysed as a total cohort and a sub-cohort, who were not currently receiving omalizumab. Treatment eligibility was defined according to the local prescribing information or protocol-defined inclusion/exclusion criteria. Patients currently receiving omalizumab were automatically categorised as omalizumab-eligible. Results: The total cohort comprised 670 patients who met the analysis criteria, of whom 20% were eligible for mepolizumab, 31-41% were eligible for omalizumab (depending on eligibility criteria used), and 5% were eligible for reslizumab. In patients not currently receiving omalizumab (n = 502), proportions eligible for each biologic were similar (mepolizumab: 20%, reslizumab 6%) or lower (omalizumab 7-21%) than those for the total cohort. Overlap in treatment eligibility varied; in mepolizumab-eligible patients not currently receiving omalizumab (n = 101), 27-37% were omalizumab-eligible and 18% were reslizumab-eligible. Conclusions: Treatment eligibility for mepolizumab and omalizumab was higher than that for reslizumab. Although there was some overlap in treatment eligibility, the patient groups eligible for treatment with anti-IL-5 or anti-IgE therapies were often distinct, emphasising the different phenotypes and endotypes in severe asthma.

Clinical characteristics and burden of illness among adolescent and adult patients with severe asthma by asthma control: the IDEAL study

“…Previously, the cross-sectional, single-visit, observational IDEAL study (17) described treatment eligibility for the biologics mepolizumab (anti-interleukin [IL]-5), omalizumab (anti-IgE), and reslizumab (anti-IL-5) in patients with SA recruited from clinical practice. The objective of this analysis was to describe the characteristics of patients with SA included in the IDEAL study, and also to explore two key patient phenotypes: severe uncontrolled asthma and severe uncontrolled asthma with frequent exacerbations aiming to support future hypothesis generation.…”

Uncontrolled severe asthma: starting from the unmet needs

“…Such biomarkers would be particularly helpful in the case of patients potentially eligible for more than one treatment. For example, a patient presenting high levels of eosinophils and a history of severe allergic asthma with sensitization to perennial allergens could be addressed to both anti-IgE and anti-IL5 biologics; the choice between the two treatment options is mainly based on a clinical ground and on the expertise of the clinician prescribing the drug 15 . Reducing the risk of a non-response would be optimal also for the treatment sustainability, including clinical and economic issues.…”

Biologicals targeting type 2 immunity: Lessons learned from asthma, chronic urticaria and atopic dermatitis

“…Indeed allergic asthma and eosinophilic asthma represent two side of the same coin, since both IgE and eosinophils are milestones of type 2 inflammation. The consequence is that an overlap of eligibility for the treatment with IL‐5 inhibitors and omalizumab, and in future also with dupilumab, exist . To solve this problem, a careful clinical characterization of patients is mandatory.…”