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Table 5 Approved and investigational biologic agents

From: Asthma biomarkers in the age of biologics

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
  1. FEV 1 forced expiratory volume in 1 s, LABA long-acting beta2 agonist