February 26, 2025

The Role of Biologics in Severe Asthma Patients

Asthma is a chronic respiratory condition affecting 300 million people worldwide.1 While majority of asthmatic patients are able to control their symptoms with the standard controller therapy, approximately 10% have severe asthma that remains poorly controlled despite receiving treatment with high-dose inhaler corticosteroids (ICS) plus a second controller with or without oral corticosteroids (OCS).1 Patients with severe asthma carry heavy symptom burden with frequent exacerbations, increased hospitalisation rates, and potential side effects of OCS, which can have profound consequences on their personal and professional lives.1 For these patients, biologics have emerged as a promising therapeutic option.

What are Biologics?

Biologics are a type of medication derived from biological sources such as animals, plants, or bacteria.2 Most biologics are antibodies, which are proteins designed to target and block specific molecules in the body.2 The benefits of biologics have been demonstrated in chronic inflammatory rheumatic, skin, and gastrointestinal diseases.3

Traditional asthma therapies, such as corticosteroids and bronchodilators, provide broad symptom relief by controlling inflammation and relaxing airway muscles. However, these therapies are no longer preferred due to the consequences of long-term OCS use which include diabetes, osteoporosis, and ocular disorders.4 Some cases of difficult-to-treat asthma also display subpar control despite high-dose treatment with these traditional therapies.1 In such cases, biologics may offer a more precise approach by targeting specific cells or molecules that trigger the inflammatory mechanism for asthma symptoms.2

The Role of Biologics in Asthma Therapy

Understanding the role of biologics in asthma therapy requires understanding the mechanism of severe asthma. Severe asthma, characterised by an overactive immune response, is driven by the presence of cytokines (interleukin-4, interleukin-5, and interleukin-13), which stimulate the production of immunoglobulin E (IgE), causing airway inflammation, airway hyperresponsiveness, and excess mucus production. Biologics target the specific molecular pathways responsible for distinct immune reactions:5,6

  • Anti-IgE therapies: Omalizumab is a monoclonal antibody that binds to IgE, preventing the onset of an allergic reaction.
  • Anti-IL-5 therapies: Mepolizumab, reslizumab, and benralizumab inhibit IL-5 to decrease eosinophilic inflammation, a key precursor to asthma exacerbations.
  • Anti-IL-4/Anti-IL-13 therapies: Dupilumab blocks the IL-4 and IL-13 signalling pathway, preventing airway inflammation.
  • Anti-thymic stromal lymphopoietin therapies: Tezepelumab blocks the action of thymic stromal lymphopoietin, preventing the onset of asthma exacerbations.

With six biologics currently approved for moderate-to-severe asthma, the choice of the most appropriate therapy is guided by biomarkers that identify the patient’s specific asthma type. These biomarkers include IgE antibodies, eosinophils, and fractional exhaled nitric oxide (FeNO) measured using clinical samples like blood, sputum, and exhaled air.2

Clinical outcomes of biologics

  • Reduced exacerbations: Among 5,836 patients on biologics, the frequency of exacerbations significantly reduced by 44% (p < 0.001).6
  • Improved lung function: Severe asthma patients (n = 5,551) receiving biologics exhibited improved forced expiratory volume (FEV1) by 0.11 litres (p = 0.001).6
  • Reduced hospitalisation rates: Biologic use among 2,232 patients led to 60% reduced hospitalisation rates (p = 0.143).6

Impact of biologics on asthma control and quality of life

  • Improved asthma control: A meta-analysis of biologic use in severe asthma patients revealed that the Asthma Control Questionnaire (ACQ) score decreased by 0.34 points, with an increased Asthma Control Test (ACT) score by 0.58 points, indicating improved asthma control (p < 0.001).6
  • Improved quality of life: Based on the Asthma Quality of Life Questionnaire (AQLQ), an increase by 0.38 points indicated that biologics significantly improved quality of life (p < 0.001).6
  • Improved work productivity: Severe asthma patients undergoing biological therapy reported notable workplace improvements within 6 months, including reduced absenteeism (15% to 11%; p < 0.001) and increased presenteeism (24% to 26%; p < 0.001). The overall perception of severe asthma patient’s ability to work also improved (25% to 27%; p < 0.001).7
  • Reduced corticosteroid use: The use of biologics was associated with a 63% increased probability of OCS discontinuation (p = 0.072) and a 34.7% mean reduction in OCS dose (p = 0.033).6

Biologics have changed the landscape of asthma therapy, offering hope to patients with severe, uncontrolled symptoms. By targeting the specific pathways driving inflammation, these therapies provide precise control over asthma symptoms, improving clinical outcomes and overall quality of life. As research continues to advance, the future of biologics promises even greater possibilities, ensuring that patients with asthma can breathe easier and live fuller lives.

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References:

1.         Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention 2024.

2.         Asthma and Allergy Foundation of America. Biologics for the Treatment of Asthma 2024 [Available from: https://aafa.org/asthma/asthma-treatment/biologics-asthma-treatment/.

3.         Adami G, Saag KG, Chapurlat RD, Guañabens N, Haugeberg G, Lems WF, et al. Balancing benefits and risks in the era of biologics. Ther Adv Musculoskelet Dis. 2019;11:1759720x19883973.

4.         Patel R, Naqvi SA, Griffiths C, Bloom CI. Systemic adverse effects from inhaled corticosteroid use in asthma: a systematic review. BMJ Open Respir Res. 2020;7(1).

5.         Israel E, Reddel HK. Severe and Difficult-to-Treat Asthma in Adults. N Engl J Med. 2017;377(10):965-76.

6.         Kyriakopoulos C, Gogali A, Markozannes G, Kostikas K. Biologic agents licensed for severe asthma: a systematic review and meta-analysis of randomised controlled trials. Eur Respir Rev. 2024;33(172).

7.         Leso V, Candia C, Pacella D, Molino A, Nocera C, Maniscalco M, et al. Quality of life and work functionality in severe asthma patients: the impact of biological therapies. J Occup Med Toxicol. 2024;19(1):8.

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