Real-world evidence analysis of SABA use in over 1 million patients with asthma consistently showed three or more SABA inhalers a year was associated with increased risk of severe asthma exacerbations
40% of asthma patients were overusing SABA reliever inhalers
New data reinforce GINA recommendations and national guideline changes which no longer recommend SABA as the preferred reliever
New results from the largest real-world observational data analysis of asthma inhaler therapy found that short-acting beta2-agonist (SABA) reliever overuse is a global issue adversely impacting asthma outcomes.1,2 Data from across the SABA Use IN Asthma (SABINA) global programme have been published in The Journal of Allergy and Clinical Immunology: In Practice (JACI: In Practice) and the European Respiratory Journal (ERJ).
The multi-country analyses of over 1 million patients with asthma showed use of three or more SABA inhalers per year was associated with an increased risk of severe exacerbations1,2 and a lower likelihood of controlled asthma.2 The findings were consistent regardless of country and asthma severity, and the risk of exacerbation was independent of maintenance therapy containing inhaled corticosteroids (ICS), further highlighting the need for continued efforts to improve asthma management.1,2
SABINA data from Europe and North America published in JACI: In Practice, found that approximately 40% of patients across all asthma severities were prescribed or received three or more SABA inhalers per year.1 This was associated with a 32% increase in risk of severe asthma exacerbations compared to patients receiving one or two inhalers per year, independent of ICS-containing medications used.1
Jennifer Quint, Professor of Respiratory Epidemiology at the National Heart and Lung Institute at Imperial College London, Honorary Consultant in Respiratory Medicine based at The Royal Brompton Hospital, London, UK and lead author of the JACI: In Practice publication, said: “As the largest analysis of clinical outcomes related to the use of reliever and maintenance therapies to date, the SABINA findings reveal that high use of SABA relievers is a common issue in many countries and is associated with a greater risk of severe asthma attacks in patients around the world. These data reinforce the urgent need to adopt treatment paradigms that improve asthma management, including those from the Global Initiative for Asthma, which no longer recommend SABA as the preferred reliever therapy across all asthma severities.”
SABINA data from 24 countries across five continents, published in the ERJ, demonstrated that 38% of patients were prescribed three or more SABA relievers a year.2 This was associated with an increasing rate of severe exacerbations and a lower likelihood of satisfactory symptom control. Patients prescribed three to five SABA relievers a year had 40% more severe exacerbations compared to patients receiving one or two inhalers per year. This rose further with increasing numbers of SABA prescriptions.2
Eric D. Bateman, Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa and lead author of the ERJ publication, said: "The SABINA programme shows that the overuse of SABA is a global problem of considerable magnitude, associated with negative outcomes of asthma treatment. It brings into focus the need for renewed efforts to reduce over-reliance on SABAs and the adoption of treatment strategies that provide both quick symptom relief and an anti-inflammatory effect.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Results from SABINA across diverse patient populations and healthcare systems add to the body of evidence demonstrating SABA overuse is associated with an increased risk of exacerbations in patients with asthma. With more than 176 million asthma attacks experienced globally each year, there is a clear need for asthma management that addresses the inflammatory nature of the disease and reduces exacerbation risk to improve outcomes for patients.”
Notes
Asthma
Asthma is a chronic, inflammatory, fluctuating respiratory disease3 that affects as many as 339 million adults and children worldwide.3 Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.4 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.5,6
There are an estimated 176 million asthma exacerbations globally per year;7 these are physically threatening and emotionally significant for many patients8 and can be fatal.3,4
Inflammation is central to both asthma symptoms4 and exacerbations.9 Many patients experiencing asthma symptoms use a SABA as a reliever medication, however taking a SABA alone does not address inflammation, leaving patients at risk of exacerbations,10 which can result in impaired quality of life,11 hospitalisation and frequent oral corticosteroids (OCS) use.12 Repeated courses of OCS therapy are associated with an increased risk of systemic side effects including pneumonia, osteoporosis and type 2 diabetes.13,14 International recommendations from the Global Initiative for Asthma (GINA) no longer recommend SABA as the preferred reliever therapy across all asthma severities.4
SABINA
The SABA Use IN Asthma (SABINA) programme, funded by AstraZeneca, is the largest real-world data analysis of clinical outcomes related to SABA use and maintenance therapy in asthma, consisting of an innovative framework of harmonised, large-scale observational studies across 40 countries. The SABINA programme examines patterns of prescription and receiving of SABA and ICS-containing medication as a surrogate measure of medication use. The studies evaluated diverse asthma populations, healthcare systems and asthma management strategies on data collected between 2007 and 2017.1,2,10,15,16
SABINA includes over 1 million asthma patients globally and has four main pillars:
- SABINA I – Retrospective observational database study in the UK1
- SABINA II – Retrospective observational database study in 8 countries (France, Germany, Italy, Netherlands, Spain, Sweden, Canada and Israel)1
- SABINA III – Cross-sectional study conducted in 24 countries across 5 continents2
- SABINA+ – Multi-design extended pillar for countries that joined after initiation of the programme (China, Hong Kong, Morocco, Poland, Romania, Switzerland, and the US)1
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main disease areas and is a key growth driver for the Company.
AstraZeneca is an established leader in respiratory care with a 50-year heritage. The Company aims to transform the treatment of asthma and chronic obstructive pulmonary disease (COPD) by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Company’s early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.
With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company’s growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
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References
1. Quint JK, et al.; on behalf of SABINA European and North American Study contributors. Short-acting β2-agonist exposure and severe asthma exacerbations: SABINA findings from Europe and North America. J Allergy Clin Immunol Pract 2022; DOI: https://doi.org/10.1016/j.jaip.2022.02.047. Epub ahead of print.
2. Bateman ED, et al. Short-acting β2-agonist prescriptions are associated with poor clinical outcomes of asthma: the multi-country, cross-sectional SABINA III study. Eur Respir J 2021; Sep 24:2101402. doi: 10.1183/13993003.01402-2021. Epub ahead of print. PMID: 34561293.
3. The Global Asthma Network. The Global Asthma Report 2018. [Online]. Available at: http://www.globalasthmanetwork.org/. [Last accessed: March 2022]
4. Global Initiative for Asthma. 2021 GINA Report, Global Strategy for Asthma Management and Prevention. [Online]. Available at: https://ginasthma.org/wp-content/uploads/2021/04/GINA-2021-Main-Report_FINAL_21_04_28-WMS.pdf [Last accessed: March 2022]
5. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009.
6. Papi A, et al. Relationship of inhaled corticosteroid adherence to asthma exacerbations in patients with moderate-to-severe asthma. J Allergy Clin Immunol Pract. 2018; 6 (6): 1989-98.e3.
7. AstraZeneca Pharmaceuticals. Data on file. Budesonide/formoterol: Annual Rate of Exacerbations Globally (ID:SD-3010-ALL-0017).
8. Sastre J, et al. Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016; 9: 13.
9. Wark PA, et al. Asthma exacerbations· 3: pathogenesis. Thorax. 2006; 61 (10): 909-15.
10. Nwaru BI, et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J. 2020; 55 (4): 1901872.
11. Lloyd A, et al. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007; 16 (1): 22-7.
12. Bourdin A, et al. ERS/EAACI statement on severe exacerbations in asthma in adults: facts, priorities and key research questions. Eur Respir J. 2019; 54 (3): 1900900
13. Price DB, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018; 11: 193–204.
14. Sullivan PW, et al. Oral corticosteroid exposure and adverse effects in asthmatic patients. J Allergy Clin Immunol. 2018; 141: 110-116.e7
15. Bloom CI, et al. Asthma-Related Health Outcomes Associated with Short-Acting β2-Agonist Inhaler Use: An Observational UK Study as Part of the SABINA Global Program. Adv Ther 2020; 37: 4190–4208
16. Cabrera CS, et al. SABINA: global programme to evaluate prescriptions and clinical outcomes related to short-acting β2-agonist use in asthma. Eur Respir J. 2020; 55 (2): 1901858.
Veeva ID: Z4-32396
Date of Preparation: March 2022