TABLE 3.

Type 2-directed therapies based on monoclonal antibodies: key clinical trials in asthma

Th2	Drug	Patient characteristics and biomarkers	Main response	Reference
Free IgE	Omalizumab	Severe asthma on ICS+LABA; atopic status; serum IgE 30–700 IU·mL−1 (USA, age ≥12 years), 30–1300 IU·mL−1 (USA, age 6–11 years), 30–1500 IU·mL−1 (EU)	Reduced asthma exacerbations Reduction in maintenance OCS	[19]
IL-4 receptor IL-13	Dupilumab	Moderate-to-severe-uncontrolled asthma; FEV1 reversibility, persistent symptoms (ACQ­5 ≥1.5); exacerbation in past year	Decrease in asthma exacerbations Improvement in FEV1 and % change in FEV1 Reduction in maintenance OCS	[87, 88]
IL-5	Mepolizumab	Severe asthma on ICS and LABA±OCS; blood eosinophils ≥150 mm−3 at screening or ≥300 mm−3 in past year	Reduced exacerbation rates Reduction in maintenance OCS Improvement in FEV1	[89, 90]
IL-5	Reslizumab	Inadequately controlled, moderate-to-severe eosinophilic asthma (≥400 cells·μL−1 during screening)	Decrease in asthma exacerbations Improvement in FEV1	[91]
IL-5 receptor	Benralizumab	Severe asthma uncontrolled by medium/high-­dose ICS+LABA for ≥1 year; ≥2 exacerbations in previous year; baseline stratification: eosinophils <300 and ≥300 cells·μL−1	Decrease in asthma exacerbations Improvement in FEV1 Reduction in maintenance OCS	[92, 93]

Th2: T-helper cell type 2; Ig: immunoglobulin; ICS: inhaled corticosteroids; LABA: long-acting β₂-agonist; OCS: oral corticosteroids; IL: interleukin; FEV₁: forced expiratory volume in 1 s; ACQ-5: 5-item Asthma Control Questionnaire.