Biologics for severe Asthma
New Asthma Treatment
I previously discussed asthma in this column, this week I discuss biologics, a new class of drugs called monoclonal antibodies that are licenced for severe asthma. They reduce the inflammation from the in the respiratory tract. Only respiratory specialists can prescribe biologics.
Most biologics are given by subcutaneous injection once or twice a month. All biologics are an add-on option and do not replace existing reliever and preventer medication, but patients should eventually be able to reduce the dosage of existing therapies such as inhaled corticosteroids. Biologics are available to target the two subtypes of Type-2 Severe Asthma (i.e.) allergic (IgE-mediated) asthma and eosinophilic asthma
Biologic therapy drugs for severe asthma include:
- Omalizumab (Xolair®)
- Mepolizumab (Nucala®)
- Reslizumab (Cinqair®)
- Benralizumab (Fasenra®)
- Dupilumab (Dupixent®)
Of the 5 biologics listed above, Omalizumab is an anti-IgE agent, and the other 4 biologics are anti eosinophilic agents.
Biologics, are expensive (average €15,000 per year), require frequent monitoring and limited to specific clinical phenotypes meaning use is limited to strict protocols. The benefits of reduced exacerbations of asthma, reduced steroid burden, and the potential for decreased hospitalisations means health authorities are increasingly funding their use. More research is required to better identify appropriate patients for use of biologics including better use of biomarkers and phenotypes in the management of acute asthma and the selection of biologics for the right patients at the appropriate time.
In clinical trials, all 5 biologics reduced annualised exacerbation rates by at least 50% and they all improved asthma symptom scores, lung function and quality of life and allowed reductions in maintenance oral corticosteroids while maintaining a favourable safety profile.
Biologics used for asthma have a good safety profile. The most serious potential side effect of biologic therapies is an allergic or allergic-like reaction with some patients very rarely experiencing severe anaphylaxis.
Less severe but more common side effects of biologics include:
- Pain, redness, itching, and/or a burning sensation at the injection site
- Increased risk of infections such as colds, flu, and urinary tract infections
How long should biologics be used
There are currently no set guidelines on how long a biologic should be used for severe asthma. Guidelines recommend trialling a biologic for a minimum four months to determine if it improves severe asthma symptoms. Consultants are given specific guidelines of how often to review and will decide if the biologic is to continue based on response.
European guidelines on biologic use
Treatment guidelines were produced by the European Academy of Allergy and Clinical Immunology (EAACI) and published in the Journal Allergy in 2020.
EAACI Biologic Therapies recommendations
Omalizumab is indicated for adults, adolescents, and children (6 to <12 years of age) and the licence states that Omalizumab should only be considered for patients with severe confirmed IgE (immunoglobulin E) mediated asthma (i.e.) allergic asthma.
The EAACI suggest that adults with both allergic and nonallergic severe uncontrolled eosinophilic asthma may benefit from the addition of omalizumab. The EAACI less strongly recommended it for less severe asthma based on their cost benefit analysis
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To be continued…next week
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