The last several years have seen an influx of asthma biologic agents to hit the market. Here we will discuss the 5 that are currently FDA approved to treat type 2 inflammatory asthma. Type 2 asthma inflammation is triggered by IL-4, IL-5, and IL-13 along with other inflammatory mediators. Half of all patients with asthma have evidence of Type 2 inflammation. Sputum and blood eosinophils, exhaled nitric oxide, blood IgE levels and airway gene expression markers are frequently used biomarkers to diagnose Type 2 asthma. Individuals tend to have several features of increased asthma severity including reduced lung function and increased rates of asthma exacerbations and Type 2 high patients show airway remodeling and alterations in mucus production. Several monoclonal antibodies are now available to treat these patients and reduce asthma exacerbation rates.
Xolair (Omalizumab)
- targets IgE
- Biomarker is Total IgE 30-700 kU/L (>12 years) or 30-1300 kU/L (6-11 years of age)
- Originally approved in 2003; now approved for 6 years of age and up
- Administered subcutaneously every 2-4 weeks, dose based on IgE level and weight
- clinical outcomes are reduced exacerbations and oral steroid use
Cinqair (Reslizumab)
- Anti-IL-5
- Biomarker is blood eosinophil >400/uL
- Approved in 2016 for 18 years and up
- Administered as an IV infusion 3mg/kg every 4 weeks
- clinical outcome is reduced exacerbations, especially with rhinosinusitis with nasal polyps.
Nucala (Mepolizumab)
- Anti-IL-5
- Biomarker is blood eosinophil >150/uL
- Approved in 2015 for 12 years and up, and now approved for 6 years and up.
- Administered 40 mg (6-11 years old) or 100 mg (12 years and up), subcutaneously every 4 weeks.
- outcomes are reduced exacerbations and improved quality of life and lung function.
Fasenra (Benralizumab)
- Anti-IL-5R a
- Biomarker is blood eosinophil >150/uL
- Approved in 2017 for 12 and up
- 30mg SQ every 4 weeks X 3, then every 8 weeks
- outcomes are reduced exacerbations and improved lung function
Dupixent (Dupilumab)
- Anti-IL-4ra
- Biomarker is blood eosinophil >150/uL
- Approved in 2017 for 12 and up
- 400 or 600 mg loading dose, then 200 or 300 mg SQ every 2 weeks
- outcomes are reduced exacerbations and improved quality of life and lung function
These are the current asthma biologic agents available. Type 2 asthma is the most established form of asthma characterized by severe exacerbations and reduced lung function. Blood eosinophil counts are the most established biomarker to establish disease currently.