Phenotyping and unmet need assessment for biological agents in uncontrolled asthma

SETTING: Uncontrolled asthma patients at a university teaching hospital in India. OBJECTIVE: To determine the prevalence, endotypes, and need for add-on therapies in severe asthma. METHODS: This prospective study screened all patients with uncontrolled asthma, and those with uncontrolled asthma while on moderate-to-high dose inhaled corticosteroids with long-acting beta agonists (ICS + LABA) were further assessed. Endotyping and optimisation of therapy for all potentially modifiable factors were performed, followed by reassessment at 3 months of optimised treatment. Uncontrolled patients at 3 months were classified as having severe asthma and assessed for eligibility for add-on therapies. RESULTS: After screening 261 uncontrolled asthma patients, 160 patients with uncontrolled asthma on moderate-high dose ICS + LABA were included in the study (prevalence of difficult-to-treat asthma: 61.2%). On endotyping, 134 (83.75%) had T2-high endotype and 26 (16.25%) had T2-low endotype asthma. Severe asthma prevalence was 20% (32 out of 160) in this subgroup, and they were assessed for eligibility for guideline-directed add-on therapy: 12 (37.5%) were eligible for omalizumab; 18 (56.25%) were eligible for mepolizumab, benralizumab, or dupilumab; and seven (21.87%) were not eligible for any add-on therapy. CONCLUSION: T2-high asthma is five times more common than T2-low asthma, and the prevalence of severe asthma is 20% among uncontrolled asthmatics.