Asthma Management with Biologic Therapy
Introduction to Biologic Therapy
- The National Asthma Education and Prevention Program guidelines recommend considering anti-IgE therapy (omalizumab) as first-line biologic for allergic asthma with elevated IgE, which is appropriate for patients with severe allergic asthma, elevated IgE levels, and documented sensitization to multiple allergens 1
- Biological therapies target specific inflammatory pathways involved in asthma pathogenesis, with the T2-high asthma endotype being most common in patients, characterized by eosinophilic airway inflammation and allergic sensitization driven by IgE, IL-4, IL-5, and IL-13 2
Patient Selection and Diagnosis
- Confirm severe asthma diagnosis and poor control despite maximal conventional therapy, including verification of adherence to high-dose inhaled corticosteroids plus long-acting β2-agonists, documentation of multiple exacerbations, and assessment of impact on quality of life, as recommended by the American Thoracic Society and supported by 3, 4
- Determine asthma phenotype through biomarkers, including measurement of total serum IgE levels, blood eosinophil count, fractional exhaled nitric oxide testing, and confirmation of allergic sensitization through skin prick testing or specific IgE testing 2
Treatment Approach
- Omalizumab is the optimal choice for patients with severe allergic asthma, elevated IgE levels, and documented sensitization to multiple allergens, due to its mechanism of action as an anti-IgE therapy, and is FDA-approved for children ≥6 years of age 1
- The American Thoracic Society and other guideline societies support the use of omalizumab in patients with allergic asthma who have elevated IgE levels and are not adequately controlled on inhaled corticosteroids, with a strength of evidence rated as high 1
- Consider anti-IL-5 therapies like mepolizumab or benralizumab for eosinophilic non-allergic asthma, with guidance provided by the American Thoracic Society 5
- Initiate mepolizumab therapy if patient has severe persistent asthma with multiple phenotypes, history of exacerbations despite maximal conventional therapy, and blood eosinophil count ≥150 cells/μL (or history of ≥300 cells/μL), as suggested by the European Respiratory Society 6
Approved Biologics for Asthma
| Biologic | Approved Age |
|---|---|
| Omalizumab | ≥6 years |
| Mepolizumab | ≥6 years |
| Benralizumab | ≥6 years |
- Most biologics are approved for children ≥6 years, with none currently approved for children <6 years, as stated by the FDA 3
Monitoring and Adjustments
- Assess initial response after 16 weeks of treatment, evaluating reduction in exacerbations, improvement in symptom control, lung function improvement, reduction in rescue medication use, and quality of life measures, as recommended by the European Respiratory Society 7
- Assess response to biological therapy after at least 16 weeks of treatment, tracking exacerbation frequency, systemic corticosteroid use, symptom control, lung function, and quality of life, as recommended by the Global Initiative for Asthma and supported by 8, 6
- Monitor for development of anti-drug antibodies, which may occur in approximately 13% of patients receiving biological therapy, as noted by the American Academy of Allergy, Asthma, and Immunology 4
Ongoing Management and Referral
- Ongoing management should involve an asthma specialist given the severity of disease and use of biologic therapy, to ensure optimal treatment outcomes and minimize potential side effects, as recommended by the American Academy of Allergy, Asthma, and Immunology 1
- Refer patients with severe asthma being considered for biological therapy to an asthma specialist, as recommended by the National Asthma Education and Prevention Program and the American Academy of Pediatrics 3, 6
- Optimize inhaled therapy before increasing systemic immunosuppressive therapy, ensuring inhaled therapies are maximized, as recommended by the American College of Chest Physicians 4
- Environmental control measures should be implemented alongside biologic therapy, particularly for the specific allergens identified, to enhance treatment efficacy, as suggested by the National Asthma Education and Prevention Program 1