Lack of access to, ineligibility for and inadequate response to current approaches leave many patients with severe asthma poorly controlled.1
Significant unmet needs exist for patients with severe asthma1
Improved disease stability and consideration of remission as a management goal for patients living with asthma remains a long-term aspiration to improve patient care14,15
OCS, oral corticosteroid(s)
1. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. 2021. Available from: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf (Accessed May 2023); 2. Global Asthma Network. The global asthma report 2018. Available from: http://www.globalasthmareport.org/Global%20Asthma%20Report%202018.pdf (Accessed May 2023); 3. Rogliani P, et al. Pulm Ther 2020;6:47–66; 4. Caminati M, et al. J Asthma Allergy 2021;14:457–466; 5. Wang E, et al. Chest 2020;157:790–804; 6. Trevor J, et al. Ann Allergy Asthma Immunol 2021;127:579–587; 7. Ambrose CS, et al. Pragmat Obs Res 2020;11:77–90; 8. Price DB, et al. J Asthma Allergy 2018;11:193–204; 9. Chen H, et al. J Allergy Clin Immunol 2007;120:396–402; 10. Busse WW, Kraft M. Eur Respir Rev 2022;31:210176; 11. Chen S, et al. Curr Med Res Opin 2018;34:2075–2088; 12. Bleecker ER, et al. Am J Respir Crit Care Med 2020;201:276–293; 13. Canonica GW, et al. World Allergy Organ J 2019;12:100007; 14. Menzies-Gow A, et al. J Allergy Clin Immunol 2020;145:757–765; 15. Thomas D, et al. Eur Respir J 2022;60:2102583
Unmet needs in the management of patients with asthma
Asthma affects approximately 339 million people worldwide,3 of whom ~5–10% have severe or uncontrolled asthma.4
Severe asthma is defined by the Global Initiative for Asthma (GINA) as asthma that remains uncontrolled despite adherence to optimised high-dose inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA) therapy and the treatment of contributory factors, or asthma that worsens when high-dose therapy is decreased.2
The long-term goals of severe asthma management include achieving good symptom control and minimising the future risk of exacerbations and disease progression (eg, decline of lung function and persistent airflow limitation).2 In many cases where patients have poor symptom control and/or exacerbations despite medium- or high-dose ICS and LABA therapy, their asthma may appear difficult to treat because of contributory factors, such as incorrect inhaler technique, poor adherence, smoking or comorbidities, or because of incorrect diagnosis.2 For these patients, GINA recommends assessment of these contributory factors and consideration of an add-on therapy, eg, a long-acting muscarinic antagonist (LAMA).2 If problems persist, referral to a specialist centre for phenotypic assessment and consideration for add-on biologic targeted treatments are recommended.2
Confirming the diagnosis of asthma, assessing contributory factors and optimising treatment strategy are the key steps for consideration in the diagnosis and management of severe asthma.2
To date, there has been great progress in the diagnosis and management of severe asthma,5,6 with biologics representing a major advancement in the treatment landscape.7 However, many patients with severe asthma are poorly controlled.
A recent study found that approximately 60% of patients with severe asthma remained suboptimally controlled despite treatment with standard-of-care medications.8 This significant finding was described following a retrospective and prospective analysis of the International Severe Asthma Registry – a data set of 4990 patients receiving GINA Step 5 treatment or with severe asthma remaining uncontrolled at GINA Step 4 (December 2014 to December 2017). Poorly controlled asthma was defined in this study according to Asthma Control Test (score 5–15; ‘very poorly controlled’) or Asthma Control Questionnaire (score >1.5; ‘poorly controlled’) categorisations.8
Unmet needs faced by a patient with severe asthma
Suboptimal asthma control can have a significant impact on patient outcomes:
What challenges are associated with existing treatments for poorly controlled asthma?
Oral corticosteroids (OCS) are the primary therapy for resolution of acute exacerbations.16 However, patients with severe asthma are often exposed to multiple courses of OCS,17 and cumulative and chronic exposure is associated with an increased risk of side effects.12,18,19 As little as 0.5–1 g (or up to four short courses) of OCS can cause serious adverse effects, including cataracts, pneumonia, type 2 diabetes, cardiovascular disease, renal impairment and osteoporosis.12
Globally, 20–60% of patients with severe or uncontrolled asthma have received long-term OCS.18 The annual cost of OCS-related adverse events per person with severe asthma is estimated to be €1958, in Italy.19
As such, there is a clear need to avoid maintenance OCS treatment where other options are available (in line with updated recommendations by GINA)2 and to continue to develop and identify alternative steroid-sparing treatments for asthma exacerbations and for patients with severe asthma.12
Asthma is heterogeneous; patients often show activation of multiple innate and adaptive inflammatory pathways:20–22 This contributes to a significant unmet need in the management of severe uncontrolled asthma.2 Targeting specific steps of the immune-inflammatory cascade through highly selective biologic therapies offers the potential of achieving optimal disease control in several severe asthma inflammatory phenotypes.1
To learn more about the heterogeneity of severe asthma, please click here.
However, major unmet needs persist owing to lack of access and inadequate response to or ineligibility for currently available biologic treatments.1
Indeed, 72% of patients with asthma in primary care in the UK, who are thought to have severe asthma, have never been referred to a specialist.22 Globally, approximately 75% of patients with poorly controlled severe asthma (GINA Step 4/5) are not receiving biologics.8
Summary of current challenges in the diagnosis and management of severe asthma
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References
1. Caminati M, et al. J Asthma Allergy 2021;14:457–466. 2. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. 2021. Available from: https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf (Accessed May 2023). 3. Global Asthma Network. The global asthma report 2018. Available from: http://www.globalasthmareport.org/Global%20Asthma%20Report%202018.pdf (Accessed May 2023). 4. Rogliani P, et al. Pulm Ther 2020;6:47–66, 5. Charriot J, et al. Eur Respir Rev 2016;25:77–92. 6. Zervas E, et al. ERJ Open Res 2018;4:00125–02017. 7. Djukanovic R, et al. Eur Respir J 2018;52:1801671. 8. Wang E, et al. Chest 2020;157:790–804. 9. Trevor J, et al. Ann Allergy Asthma Immunol 2021;127:579–587. 10. Ambrose CS, et al. Pragmat Obs Res 2020;11:77–90. 11. Pavord ID. Curr Opin Pulm Med 2019;25:51–58. 12. Price DB, et al. J Asthma Allergy 2018;11:193–204. 13. Chen H, et al. J Allergy Clin Immunol 2007;120:396–402. 14. Busse WW, Kraft M. Eur Respir Rev 2022;31:210176. 15. Chen S, et al. Curr Med Res Opin 2018;34:2075–2088. 16. Chung LP, et al. Respirology 2020;25:161–172. 17. Papapostolou G, et al. Eur Clin Respir J 2020;8:1856024. 18. Bleecker ER, et al. Am J Respir Crit Care Med 2020;201:276–293. 19. Canonica GW, et al. World Allergy Organ J 2019;12:100007. 20. Tran TN, et al. Ann Allergy Asthma Immunol 2016;116:37–42. 21. Kupczyk M, et al. Allergy 2014;69:1198–1204. 22. Heatley H, et al. Eur Respir J 2019;54:PA2712.