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About the recommendation of the GINA strategy report on asthma step 1

Serena Ferretti, Mariannita Gelsomino, Stefano Miceli Sopo
European Respiratory Journal 2021 57: 2003324; DOI: 10.1183/13993003.03324-2020
Serena Ferretti
Dept of Woman and Child Health, Policlinico Gemelli Universitary Foundation IRCCS, Catholic University of Sacred Heart, Rome, Italy
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Mariannita Gelsomino
Dept of Woman and Child Health, Policlinico Gemelli Universitary Foundation IRCCS, Catholic University of Sacred Heart, Rome, Italy
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Stefano Miceli Sopo
Dept of Woman and Child Health, Policlinico Gemelli Universitary Foundation IRCCS, Catholic University of Sacred Heart, Rome, Italy
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Abstract

There is not yet sufficient evidence to transfer the use of as-needed low dose ICS–formoterol, as GINA has recommended since 2019, instead of as-needed SABA to patients affected by step 1 asthma https://bit.ly/2G1IieN

To the Editor:

“GINA 2019: a fundamental change in asthma management.” This is how Reddel et al. [1] headline their editorial on the report in question. Reddel et al. [1] express a fundamental concept: “GINA no longer recommends treatment of asthma in adolescents and adults with SABA alone. Instead, to reduce their risk of serious exacerbations, all adults and adolescents with asthma should receive either symptom-driven (in mild asthma) or daily inhaled corticosteroid (ICS)-containing treatment.” We have some doubts about the full suitability of this change.

For a long time, the therapy suggested for asthmatic patients at step 1 has been as-needed albuterol or another short-acting β2-agonist (SABA). This is, for example, what the international guidelines on asthma of the British Thoracic Society [2] and the National Institute for Health and Care Excellence [3], suggest. In 2019, the Global Initiative for Asthma (GINA) for the first time questioned this traditional indication [4]. GINA classifies asthma severity based on the level of therapy needed to control symptoms. According to its report, asthma controlled with as-needed therapy or daily low dose inhaled corticosteroids (ICS) is defined as “mild” and this group is composed of step 1 and step 2 patients. Since 2019, GINA has recommended as-needed low dose ICS–formoterol as the “preferred controller option” for step 1 asthma patients [4], transferring for the first time the preferable use of this association (or otherwise use of low dose ICS whenever SABA is taken) from step 2. The reason for this significant management change arises from the high importance that was given by GINA to ICS in reducing exacerbations and asthma-related deaths, and the risks of SABA-only therapy [5]. The GINA report highlights the frequency of severe exacerbations and the importance of their prevention [4], and also in mild asthma [6]. Of course, the GINA report has an excellent intention. But is it well supported? Some questions can be raised about this new step 1 approach.

Regarding GINA 2019, the recommendation was based on indirect evidence from the corresponding step 2 studies, in particular the SYGMA report [7]. According to this study, the use of as-needed budesonide–formoterol resulted in a 64% lower rate of severe exacerbations than as-needed terbutaline (annualised exacerbation rate 0.07 versus 0.20; rate ratio 0.36, 95% CI 0.27–0.49; p<0.001). The recommendation was reinforced in GINA 2020 by two further studies, the PRACTICAL [8] and Novel START [9] trials. According to the first, the rate of severe asthma exacerbations was lower with as-needed budesonide–formoterol than budesonide maintenance plus as-needed terbutaline therapy (absolute rate per patient per year 0.119 versus 0.172; relative rate 0.69, 95% CI 0.48–1,00; p=0.049) [8]. As for the second, the number of severe exacerbations in the as-needed budesonide–formoterol group was lower than the number in both the albuterol group (9/223 versus 23/220; relative risk 0.40, 95% CI 0.18–0.86) and the budesonide maintenance group (9/223 versus 21/225; relative risk 0.44, 95% CI 0.20–0.96) [9]. However, these studies involve both step 1 and step 2 patients, with no specific differences described in results.

So, how can we understand that there would be a benefit even for the patients at step 1 only? It is currently true that mild asthma can lead to severe exacerbations with a frequency ranging from 0.12 to 0.77 per patient-year [6], but this data may be affected by the presence in the study population of step 2 patients, not allowing differentiation to be made between them and step 1 patients. No direct evidence is today available about the frequency of severe exacerbation in patients who before were classifiable to step 1. Probably, this frequency is lower than that of a step 2 patient having a severe exacerbation. Thus, the difference in the incidence of severe exacerbations between patients treated with only as-needed SABA and patients treated with as-needed low dose ICS–formoterol may not be significant nor clinically irrelevant in step 1 patients.

Trying to avoid a hypothetical risk could lead to an unmotivated overtreatment this way. The currently unavailable evidence demonstrating the real need for use of ICS–formoterol association for step 1 could arise from a randomised controlled trial comparing treatment with SABA alone versus low dose ICS–formoterol in a pure population of step 1 patients.

Thus, we think that there is not yet sufficient evidence to transfer the use of ICS–formoterol, recommended in step 2, to step 1. Treating intermittent as mild persistent asthma could mean killing step 1: are you sure it would be fair?

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Footnotes

  • Conflict of interest: S. Ferretti has nothing to disclose.

  • Conflict of interest: M. Gelsomino has nothing to disclose.

  • Conflict of interest: S. Miceli Sopo has nothing to disclose.

  • Received August 31, 2020.
  • Accepted September 23, 2020.
  • ©ERS 2021.
https://www.ersjournals.com/user-licence

References

  1. ↵
    1. Reddel HK,
    2. FitzGerald JM,
    3. Bateman ED, et al.
    GINA 2019: a fundamental change in asthma management: treatment of asthma with short-acting bronchodilators alone is no longer recommended for adults and adolescents. Eur Respir J 2019; 53: 1901046.
    OpenUrlAbstract/FREE Full Text
  2. ↵
    BTS/SIGN British Guideline on the Management of Asthma 2019. www.brit-thoracic.org.uk/quality-improvement/guidelines/asthma/ Date last accessed: 28 Aug 2020.
  3. ↵
    National Institute for Health and Care Excellence. NICE Guideline 2017: Asthma: Diagnosis, Monitoring and Chronic Asthma Management. Update February 2020. www.nice.org.uk/guidance/ng80/resources/asthma-diagnosis-monitoring-and-chronic-asthma-management-pdf-1837687975621 Date last accessed: 28 Aug 2020.
  4. ↵
    1. Global Initiative for Asthma
    . Global Strategy for Asthma Management and Prevention, 2019. www.ginasthma.org Date last accessed: 28 Aug 2020.
  5. ↵
    1. Nwaru BI,
    2. Ekström M,
    3. Hasvold P, 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: 1901872.
    OpenUrlAbstract/FREE Full Text
  6. ↵
    1. Dusser D,
    2. Montani D,
    3. Chanez P, et al.
    Mild asthma: an expert review on epidemiology, clinical characteristics and treatment recommendations. Allergy 2007; 62: 591–604.
    OpenUrlCrossRefPubMed
  7. ↵
    1. O'Byrne PM,
    2. FitzGerald JM,
    3. Bateman ED, et al.
    Inhaled combined budesonide-formoterol as needed in mild asthma. N Engl J Med 2018; 378: 1865–1876.
    OpenUrlCrossRefPubMed
  8. ↵
    1. Hardy J,
    2. Baggott C,
    3. Fingleton J, et al.
    Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): a 52-week, open-label, multicentre, superiority, randomised controlled trial. Lancet 2019; 394: 919–928.
    OpenUrlPubMed
  9. ↵
    1. Beasley R,
    2. Holliday M,
    3. Reddel HK, et al.
    Controlled trial of budesonide-formoterol as needed for mild asthma. N Engl J Med 2019; 380: 2020–2030.
    OpenUrlPubMed
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About the recommendation of the GINA strategy report on asthma step 1
Serena Ferretti, Mariannita Gelsomino, Stefano Miceli Sopo
European Respiratory Journal Feb 2021, 57 (2) 2003324; DOI: 10.1183/13993003.03324-2020

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About the recommendation of the GINA strategy report on asthma step 1
Serena Ferretti, Mariannita Gelsomino, Stefano Miceli Sopo
European Respiratory Journal Feb 2021, 57 (2) 2003324; DOI: 10.1183/13993003.03324-2020
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