Table 5 Approved and investigational biologic agents
Approved agent | Indication | Therapeutic target | Biomarkers | Dosing | |
|---|---|---|---|---|---|
Omalizumab (Xolair®) | Moderate to severe persistent allergic asthma Positive skin test or in vitro reactivity to a perennial aeroallergen Patient is inadequately controlled with ICS ≥6 years of age; add-on therapy for 6–11 years of age Chronic idiopathic urticaria Symptomatic despite H1 antihistamine treatment ≥12 years of age US As Canadian PM, except that eligible patient age is ≥ 6 years EU Add-on therapy to improve control of severe persistent allergic (convincing IgE-mediated) asthma in patients aged ≥ 6 years Positive skin test or in vitro reactivity to a perennial aeroallergen + frequent daytime symptoms or night-time awakenings ≥12 years: reduced lung function (FEV1 < 80%) Multiple documented exacerbations despite daily high-dose ICS + long-acting inhaled beta2-agonist | IgE | IgE (serum) Periostin (serum, sputum) | 75–375 mg SC every 2–4 weeks Dose determined by serum total IgE level and body weight | |
Mepolizumab (Nucala®) | Severe eosinophilic asthma Add-on maintenance treatment ≥ 12 years of age Patient is inadequately controlled with high-dose ICS and ≥ 1 additional asthma controller Blood eosinophil count ≥ 150 cells/μL at initiation of treatment or ≥ 300 cells/μL in the past 12 months US As Canadian PM No details provided on lack of control on other asthma medication or specific blood eosinophil level EU As Canadian PM Specifies refractory nature of severe eosinophilic asthma Adult patients No details provided on specific blood eosinophil level | IL-5 | Eosinophil (blood, sputum) | 100 mg SC every 4 weeks | |
Reslizumab (Cinqair™) | Severe eosinophilic asthma Add-on maintenance treatment ≥ 18 years of age Patient is inadequately controlled with medium- to high-dose ICS and ≥ 1 additional asthma controller Blood eosinophil count ≥ 400 cells/μL at initiation of treatment US As Canadian PM No details provided on lack of control on other asthma medication or specific blood eosinophil level EU As Canadian PM No details provided on specific blood eosinophil level Specifies high-dose ICS | IL-5 | Eosinophil (blood, sputum) | 3 mg/kg IV (20–50 min) every 4 weeks |
Investigational agent | Therapeutic target | Biomarkers | Study population(s) | Study dosing | Study results |
|---|---|---|---|---|---|
Benralizumab | IL-5Rα | Eosinophil (blood, sputum) | Patients with severe eosinophilic asthma (blood eosinophil count ≥ 300 cells/µL) ≥ 12 years of age Uncontrolled (≥ 2 exacerbations) despite high-dose ICS and LABA use | 30 mg SC every 4 or 8 weeks | Significant reduction of annual asthma exacerbation rate Significantly improved prebronchodilator FEV1 |
Dupilumab | IL-4/IL-13 | Eosinophil (blood, sputum) | Patients with uncontrolled persistent asthma ≥ 18 years of age Taking medium- to high-dose ICS and a LABA | 200 or 300 mg SC every 2 weeks or every 4 weeks | Significant increases in FEV1 Reduction in severe exacerbations |
Lebrikizumab | IL-13 | Periostin Eosinophil (blood) | Patients with uncontrolled asthma ≥ 18 years of age Pre-bronchodilator FEV1 40–80% predicted Periostin ≥ 50 ng/mL or blood eosinophils ≥ 300 cells/μL ICS and ≥ 1 controller medication | 37.5 or 125 mg SC every 4 weeks | No consistent significant reduction in exacerbations |
Tralokinumab | IL-13 | Periostin DPP-4 | Patients with severe uncontrolled asthma ≥ 18 years of age Taking high-dose ICS and a LABA | 300 mg SC every 2 or 4 weeks | No significant reduction in exacerbation rate Dosing every 2 weeks significantly improved prebronchodilator FEV1 |