Biologics in Asthma: Changing the Severe Asthma Paradigm

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Biologics in Asthma: Changing the Severe Asthma Paradigm
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Shyam Subramanian, MD, FCCP

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References
  1. Shah PA, Brightling C. Biologics for severe asthma—which, when and why? Respirology. 2023;28(8):709-721. doi:10.1111/resp.14520
  2. Rogers L, Jesenak M, Bjermer L, Hanania NA, Seys SF, Diamant Z. Biologics in severe asthma: a pragmatic approach for choosing the right treatment for the right patient. Respir Med. 2023;218:107414. doi:10.1016/j.rmed.2023.107414
  3. Frøssing L, Silberbrandt A, Von Bülow A, Backer V, Porsbjerg C. The Prevalence of Subtypes of Type 2 Inflammation in an Unselected Population of Patients with Severe Asthma. J Allergy Clin Immunol Pract. 2021;9(3):1267-1275. doi:10.1016/j.jaip.2020.09.051
  4. McGregor MC, Krings JG, Nair P, Castro M. Role of biologics in asthma. Am J Respir Crit Care Med. 2019;199(4):433-445. doi:10.1164/rccm.201810-1944CI
  5. d'Ancona G, Kavanagh J, Roxas C, et al. Adherence to corticosteroids and clinical outcomes in mepolizumab therapy for severe asthma. Eur Respir J. 2020;55(5):1902259. Published 2020 May 7. doi:10.1183/13993003.02259-2019
  6. Exacerbation reduction & other clinical information | TEZSPIRE® (tezepelumab-Ekko) for hcps. Accessed July 25, 2024. https://www.tezspirehcp.com/efficacy-and-clinical-data/exacerbation-reductions-and-clinical-in-formation.html
  7. Exacerbation reduction in patients 12+ years. DUPIXENT® (dupilumab) for healthcare providers. Accessed June 18, 2024. https://www.dupixenthcp.com/asthma/efficacy/exacerbations
  8. Korn S, Bourdin A, Chupp G, et al. Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4. doi:10.1016/j.jaip.2021.07.058
  9. Jackson DJ, Heaney LG, Humbert M, et al; for the SHAMAL Investigators. Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study [published correction appears in Lancet. 2024;403(10432):1140]. Lancet. 2024;403(10423):271-281. doi:10.1016/S0140-6736(23)02284-5
  10. Thomas D, McDonald VM, Stevens S, et al. Biologics (mepolizumab and omalizumab) induced remission in severe asthma patients. Allergy. 2024;79(2):384-392. doi:10.1111/all.15867
  11. Hansen S, Baastrup Søndergaard M, von Bülow A, et al. Clinical response and remission in patients with severe asthma treated with biologic therapies. Chest. 2024;165(2):253-266. doi:10.1016/j.chest.2023.10.046
  12. Bagnasco D, Savarino EV, Yacoub MR, et al. Personalized and precision medicine in asthma and eosinophilic esophagitis: the role of T2 target therapy. Pharmaceutics. 2023;15(9):2359. doi:10.3390/pharmaceutics15092359
  13. Wang E, Wechsler ME, Tran TN, et al. Characterization of severe asthma worldwide: data from the International Severe Asthma Registry [published correction appears in Chest. 2021;160(5):1989.]. Chest. 2020;157(4):790-804. doi:10.1016/j.chest.2019.10.053
  14. Inselman JW, Jeffery MM, Maddux JT, Shah NS, Rank MA. Trends and Disparities in Asthma Biologic Use in the United States. J Allergy Clin Immunol Pract. 2020;8(2):549-554.e1. doi:10.1016/j.jaip.2019.08.024
  15. Pelaia C, Crimi C, Vatrella A, Tinello C, Terracciano R, Pelaia G. Molecular targets for biological therapies of severe asthma. Front Immunol. 2020;11:603312. doi:10.3389/fimmu.2020.603312
  16. Biologics for the treatment of asthma. Asthma and Allergy Foundation of America. Reviewed November 2023. Accessed June 18, 2024. https://aafa.org/asthma/asthma-treatment/biologics-asthma-treatment/
  17. Safety profile. TEZSPIRE® (tezepelumab-ekko) for healthcare providers. Accessed June 18, 2024. https://www.tezspirehcp.com/safety-profile.html
  18. Nucala (mepolizumab) for hcps. Severe Eosinophilic Asthma | NUCALA (mepolizumab) for HCPs. Accessed August 1, 2024. https://nucalahcp.com/severe-eosinophilic-asthma/.
  19. Xolair® (omalizumab). xolair. Accessed August 1, 2024. https://www.xolairhcp.com/allergic-asthma/side-effects/summary.html.
  20. Cinqair. Cinqairhcp.com. Accessed August 1, 2024. https://www.cinqairhcp.com/efficacy-and-safety-profiles/.
Author and Disclosure Information

Shyam Subramanian, MD, FCCP
Chief, Division of Pulmonary Critical Care
Sutter Health
Tracy, CA

Dr. Subramanian has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Sanofi; GSK; AZ

Publications
MDedge Internal Medicine
CHEST Physician
Topics
Asthma
Author(s)
Shyam Subramanian, MD, FCCP
Author(s)
Shyam Subramanian, MD, FCCP
Author and Disclosure Information

Shyam Subramanian, MD, FCCP
Chief, Division of Pulmonary Critical Care
Sutter Health
Tracy, CA

Dr. Subramanian has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Sanofi; GSK; AZ

Author and Disclosure Information

Shyam Subramanian, MD, FCCP
Chief, Division of Pulmonary Critical Care
Sutter Health
Tracy, CA

Dr. Subramanian has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Sanofi; GSK; AZ

Click to view more from Pulmonology Data Trends 2024. 

Click to view more from Pulmonology Data Trends 2024. 

References
  1. Shah PA, Brightling C. Biologics for severe asthma—which, when and why? Respirology. 2023;28(8):709-721. doi:10.1111/resp.14520
  2. Rogers L, Jesenak M, Bjermer L, Hanania NA, Seys SF, Diamant Z. Biologics in severe asthma: a pragmatic approach for choosing the right treatment for the right patient. Respir Med. 2023;218:107414. doi:10.1016/j.rmed.2023.107414
  3. Frøssing L, Silberbrandt A, Von Bülow A, Backer V, Porsbjerg C. The Prevalence of Subtypes of Type 2 Inflammation in an Unselected Population of Patients with Severe Asthma. J Allergy Clin Immunol Pract. 2021;9(3):1267-1275. doi:10.1016/j.jaip.2020.09.051
  4. McGregor MC, Krings JG, Nair P, Castro M. Role of biologics in asthma. Am J Respir Crit Care Med. 2019;199(4):433-445. doi:10.1164/rccm.201810-1944CI
  5. d'Ancona G, Kavanagh J, Roxas C, et al. Adherence to corticosteroids and clinical outcomes in mepolizumab therapy for severe asthma. Eur Respir J. 2020;55(5):1902259. Published 2020 May 7. doi:10.1183/13993003.02259-2019
  6. Exacerbation reduction & other clinical information | TEZSPIRE® (tezepelumab-Ekko) for hcps. Accessed July 25, 2024. https://www.tezspirehcp.com/efficacy-and-clinical-data/exacerbation-reductions-and-clinical-in-formation.html
  7. Exacerbation reduction in patients 12+ years. DUPIXENT® (dupilumab) for healthcare providers. Accessed June 18, 2024. https://www.dupixenthcp.com/asthma/efficacy/exacerbations
  8. Korn S, Bourdin A, Chupp G, et al. Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4. doi:10.1016/j.jaip.2021.07.058
  9. Jackson DJ, Heaney LG, Humbert M, et al; for the SHAMAL Investigators. Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study [published correction appears in Lancet. 2024;403(10432):1140]. Lancet. 2024;403(10423):271-281. doi:10.1016/S0140-6736(23)02284-5
  10. Thomas D, McDonald VM, Stevens S, et al. Biologics (mepolizumab and omalizumab) induced remission in severe asthma patients. Allergy. 2024;79(2):384-392. doi:10.1111/all.15867
  11. Hansen S, Baastrup Søndergaard M, von Bülow A, et al. Clinical response and remission in patients with severe asthma treated with biologic therapies. Chest. 2024;165(2):253-266. doi:10.1016/j.chest.2023.10.046
  12. Bagnasco D, Savarino EV, Yacoub MR, et al. Personalized and precision medicine in asthma and eosinophilic esophagitis: the role of T2 target therapy. Pharmaceutics. 2023;15(9):2359. doi:10.3390/pharmaceutics15092359
  13. Wang E, Wechsler ME, Tran TN, et al. Characterization of severe asthma worldwide: data from the International Severe Asthma Registry [published correction appears in Chest. 2021;160(5):1989.]. Chest. 2020;157(4):790-804. doi:10.1016/j.chest.2019.10.053
  14. Inselman JW, Jeffery MM, Maddux JT, Shah NS, Rank MA. Trends and Disparities in Asthma Biologic Use in the United States. J Allergy Clin Immunol Pract. 2020;8(2):549-554.e1. doi:10.1016/j.jaip.2019.08.024
  15. Pelaia C, Crimi C, Vatrella A, Tinello C, Terracciano R, Pelaia G. Molecular targets for biological therapies of severe asthma. Front Immunol. 2020;11:603312. doi:10.3389/fimmu.2020.603312
  16. Biologics for the treatment of asthma. Asthma and Allergy Foundation of America. Reviewed November 2023. Accessed June 18, 2024. https://aafa.org/asthma/asthma-treatment/biologics-asthma-treatment/
  17. Safety profile. TEZSPIRE® (tezepelumab-ekko) for healthcare providers. Accessed June 18, 2024. https://www.tezspirehcp.com/safety-profile.html
  18. Nucala (mepolizumab) for hcps. Severe Eosinophilic Asthma | NUCALA (mepolizumab) for HCPs. Accessed August 1, 2024. https://nucalahcp.com/severe-eosinophilic-asthma/.
  19. Xolair® (omalizumab). xolair. Accessed August 1, 2024. https://www.xolairhcp.com/allergic-asthma/side-effects/summary.html.
  20. Cinqair. Cinqairhcp.com. Accessed August 1, 2024. https://www.cinqairhcp.com/efficacy-and-safety-profiles/.
References
  1. Shah PA, Brightling C. Biologics for severe asthma—which, when and why? Respirology. 2023;28(8):709-721. doi:10.1111/resp.14520
  2. Rogers L, Jesenak M, Bjermer L, Hanania NA, Seys SF, Diamant Z. Biologics in severe asthma: a pragmatic approach for choosing the right treatment for the right patient. Respir Med. 2023;218:107414. doi:10.1016/j.rmed.2023.107414
  3. Frøssing L, Silberbrandt A, Von Bülow A, Backer V, Porsbjerg C. The Prevalence of Subtypes of Type 2 Inflammation in an Unselected Population of Patients with Severe Asthma. J Allergy Clin Immunol Pract. 2021;9(3):1267-1275. doi:10.1016/j.jaip.2020.09.051
  4. McGregor MC, Krings JG, Nair P, Castro M. Role of biologics in asthma. Am J Respir Crit Care Med. 2019;199(4):433-445. doi:10.1164/rccm.201810-1944CI
  5. d'Ancona G, Kavanagh J, Roxas C, et al. Adherence to corticosteroids and clinical outcomes in mepolizumab therapy for severe asthma. Eur Respir J. 2020;55(5):1902259. Published 2020 May 7. doi:10.1183/13993003.02259-2019
  6. Exacerbation reduction & other clinical information | TEZSPIRE® (tezepelumab-Ekko) for hcps. Accessed July 25, 2024. https://www.tezspirehcp.com/efficacy-and-clinical-data/exacerbation-reductions-and-clinical-in-formation.html
  7. Exacerbation reduction in patients 12+ years. DUPIXENT® (dupilumab) for healthcare providers. Accessed June 18, 2024. https://www.dupixenthcp.com/asthma/efficacy/exacerbations
  8. Korn S, Bourdin A, Chupp G, et al. Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4. doi:10.1016/j.jaip.2021.07.058
  9. Jackson DJ, Heaney LG, Humbert M, et al; for the SHAMAL Investigators. Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study [published correction appears in Lancet. 2024;403(10432):1140]. Lancet. 2024;403(10423):271-281. doi:10.1016/S0140-6736(23)02284-5
  10. Thomas D, McDonald VM, Stevens S, et al. Biologics (mepolizumab and omalizumab) induced remission in severe asthma patients. Allergy. 2024;79(2):384-392. doi:10.1111/all.15867
  11. Hansen S, Baastrup Søndergaard M, von Bülow A, et al. Clinical response and remission in patients with severe asthma treated with biologic therapies. Chest. 2024;165(2):253-266. doi:10.1016/j.chest.2023.10.046
  12. Bagnasco D, Savarino EV, Yacoub MR, et al. Personalized and precision medicine in asthma and eosinophilic esophagitis: the role of T2 target therapy. Pharmaceutics. 2023;15(9):2359. doi:10.3390/pharmaceutics15092359
  13. Wang E, Wechsler ME, Tran TN, et al. Characterization of severe asthma worldwide: data from the International Severe Asthma Registry [published correction appears in Chest. 2021;160(5):1989.]. Chest. 2020;157(4):790-804. doi:10.1016/j.chest.2019.10.053
  14. Inselman JW, Jeffery MM, Maddux JT, Shah NS, Rank MA. Trends and Disparities in Asthma Biologic Use in the United States. J Allergy Clin Immunol Pract. 2020;8(2):549-554.e1. doi:10.1016/j.jaip.2019.08.024
  15. Pelaia C, Crimi C, Vatrella A, Tinello C, Terracciano R, Pelaia G. Molecular targets for biological therapies of severe asthma. Front Immunol. 2020;11:603312. doi:10.3389/fimmu.2020.603312
  16. Biologics for the treatment of asthma. Asthma and Allergy Foundation of America. Reviewed November 2023. Accessed June 18, 2024. https://aafa.org/asthma/asthma-treatment/biologics-asthma-treatment/
  17. Safety profile. TEZSPIRE® (tezepelumab-ekko) for healthcare providers. Accessed June 18, 2024. https://www.tezspirehcp.com/safety-profile.html
  18. Nucala (mepolizumab) for hcps. Severe Eosinophilic Asthma | NUCALA (mepolizumab) for HCPs. Accessed August 1, 2024. https://nucalahcp.com/severe-eosinophilic-asthma/.
  19. Xolair® (omalizumab). xolair. Accessed August 1, 2024. https://www.xolairhcp.com/allergic-asthma/side-effects/summary.html.
  20. Cinqair. Cinqairhcp.com. Accessed August 1, 2024. https://www.cinqairhcp.com/efficacy-and-safety-profiles/.
Publications
MDedge Internal Medicine
CHEST Physician
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CHEST Physician
Topics
Asthma
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Biologics in Asthma: Changing the Severe Asthma Paradigm
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The introduction of biologic therapies has revolutionized the treatment paradigm for severe asthma, particularly for type 2 mediated disease, which accounts for 70%-80% of all cases.1-3 Biologics have shown significant reductions in asthma exacerbations, decreased reliance on oral steroids, reduced daily rescue inhaler use, improved lung function, and enhanced overall quality of life for patients who remained poorly controlled on conventional treatments.2,4,5 Tezepelumab and dupilumab reduce exacerbations by up to 71% and 70%, respectively.4,6

Biologics also show enduring efficacy. Of the patients who continued dupilumab for 3 years or benralizumab for 5 years, 89% and 87% experienced zero exacerbations, respectively.7,8 Biologics have reduced the need for inhaled corticosteroid maintenance therapy, with up to 91% of patients having zero exacerbations after stopping inhaled corticosteroids while on a biologic.9 This is paving the way for asthma remission. In fact, a recent study found that up to 29% of patients met criteria for remission while on biologic therapy.10,11

Selecting the right biologic is crucial and involves appropriately phenotyping the patient based on their history and using biomarkers such as absolute blood eosinophil count (AEC), immunoglobulin E (IgE), fractional exhaled nitric oxide (FeNO) levels, and allergy panels.4 New biologics are also being developed to expand the range of biologic treatments available.12

Biologics represent a breakthrough for severe asthma. Despite their promise, only 25% of eligible patients receive biologics, highlighting the need for increased clinician education.13 Moreover, disparities in access to these agents remains a concern due to the elevated cost of treatment.14

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