gina 2019: a fundamental change in asthma management

Levy is lead on asthma and joint lead for COPD in developing dashboards for clinical care for general practitioners in London, outside the submitted work. Print 2020 Feb. Muneswarao J, Hassali MA, Ibrahim B, Saini B, Ali IAH, Verma AK. 53, Eur Resp J. England; 2019. Conflict of interest: H.K. What changed, and why is it important? Other populations in whom as-needed ICS–formoterol should be investigated include pregnant women, where protection from exacerbations with a very low dose of ICS may be particularly attractive, and patients with seasonal allergic asthma. GINA also provides additional as-needed controller options for Step 2 strategies that may reduce exacerbations, albeit with limited evidence. GINA 2019: a fundamental change in asthma management: Treatment of asthma with short-acting bronchodilators alone is no longer recommended for adults and adolescents. [22]. Drug Ther Bull. Patient reliance on SABA was further reinforced by its prominent use in the trusted environments of emergency department and hospital care. 2017 Feb;72(2):183-200. doi: 10.1111/all.13039. European Respiratory Society442 Glossop RoadSheffield S10 2PXUnited KingdomTel: +44 114 2672860Email: journals@ersnet.org, Print ISSN:  0903-1936 Even in resource-rich countries, despite the best efforts of health professionals, adherence to maintenance treatment with ICS in mild asthma remains a distant hope. Therapy Working Group of the National Asthma Task Force and the MRC General Practice Research Framework, Low-dose inhaled corticosteroids and the prevention of death from asthma, Regular use of inhaled corticosteroids and the long term prevention of hospitalisation for asthma, Low dose inhaled budesonide and formoterol in mild persistent asthma: the OPTIMA randomized trial, Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial, Concluding remarks: can we explain the association of beta-agonists with asthma mortality? 2019 Nov 21;54(5):1901583. doi: 10.1183/13993003.01583-2019. 2019 Nov 21;54(5). Bacharier reports personal fees for lecturing and consultancy from Aerocrine, GlaxoSmithKline, Genentech/Novartis, Teva, Boehringer Ingelheim and AstraZeneca, personal fees for advisory board work from Merck and Circassia, personal fees for data monitoring committee work from DBV Technologies, personal fees for CME programme development from WebMD/Medscape, personal fees for lecturing and advisory board work from Sanofi/Regeneron, personal fees for consultancy and advisory board work from Vectura, outside the submitted work. Instead, they should receive symptom-driven (in mild asthma) or a daily corticosteroid-containing inhaler, to reduce risk of severe exacerbations. Conflict of interest: H.K. pii: 1901860. doi: 10.1183/13993003.01860-2019. The authors are members of the GINA Science Committee and/or the GINA Board. Conflict of interest: J.M. A hypothesis, Double trouble: impact of inappropriate use of asthma medication on the use of health care resources, A 10 year asthma programme in Finland: major change for the better, Rapid reduction in hospitalisations after an intervention to manage severe asthma, Quantifying the proportion of severe asthma exacerbations attributable to inhaled corticosteroid nonadherence, Compliance, adherence, and concordance: implications for asthma treatment, Asthma and adherence to inhaled corticosteroids: current status and future perspectives. Pedersen reports personal fees for lectures and consultancy from Astrazeneca, personal fees for consultancy from ALK and Thermofisher, outside the submitted work. ‘GINA 2019: a fundamental change in asthma management’, is the title of a short, free editorial in Eur Respir J that summarises the key recommendations, provides evidence and outlines the rationale for … Conflict of interest: J.A. GINA recommendations in adults with symptomatic mild asthma and a smoking history. Combination ICS–SABAs are available in a few countries, but with limited safety data. The 2019 update, published in April, was perhaps the most fundamental change in asthma management in 30 yr. Reddel HK, FitzGerald JM, Bateman ED, et al. This site needs JavaScript to work properly. 2020 Dec 18;21(24):9658. doi: 10.3390/ijms21249658. 1. The 2019 Global Initiative for Asthma (GINA) treatment strategy figure for adults and adolescents, annotated to highlight key features. Are asthma medications and management related to deaths from asthma? Ko has nothing to disclose. Eur Respir J. 2019… This was the most fundamental change in … Sign In to Email Alerts with your Email Address, GINA 2019: a fundamental change in asthma management, A brief history of inhaled asthma therapy over the last fifty years, A cohort analysis of excess mortality in asthma and the use of inhaled beta-agonists. Conflict of interest: J. Lin has nothing to disclose. Conflict of interest: G. Brusselle reports personal fees for lecturing and advisory board work from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis and Teva, personal fees for advisory board work from Sanofi, outside the submitted work. However, it was recognised that this cut-off was arbitrary, and that patients with infrequent symptoms would be unlikely to be adherent with daily ICS, reverting to SABA-only treatment. Eur Respir J. Eur. The further paradoxes of asthma management: time for a new approach across the spectrum of asthma severity, Combination formoterol and budesonide as maintenance and reliever therapy, Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma, As-needed budesonide-formoterol versus maintenance budesonide in mild asthma, Inhaled combined budesonide-formoterol as needed in mild asthma, Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study, Combination of budesonide/formoterol on demand improves asthma control by reducing exercise-induced bronchoconstriction, Beclometasone–formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial, Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): a randomised, double-blind, placebo-controlled trial, Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: the BASALT randomized controlled trial, Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children, Association of inhaled corticosteroids and long-acting beta-agonists as controller and quick relief therapy with exacerbations and symptom control in persistent asthma: A systematic review and meta-analysis, Mild asthma: an expert review on epidemiology, clinical characteristics and treatment recommendations, Controlled trial of budesonide-formoterol as needed for mild asthma, Description of the protocol for the PRACTICAL study: a randomised controlled trial of the efficacy and safety of ICS/LABA reliever therapy in asthma, Household air pollution and adult respiratory health, www.rcplondon.ac.uk/file/868/download?token=3wikiuFg. Modified with permission of the Global Initiative for Asthma (www.ginasthma.org). Conflict of interest: H. Inoue reports grants from Boehringer Ingelheim, Kyorin, MeijiSeikaPharma, Novartis, Ono, Taiho and Teijin-Pharma, personal fees for lecturing and advisory board work from Astellas, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Kyorin, Merck Sharp & Dohme, Novartis, Otsuka and Sanofi, outside the submitted work. J. Eur Respir J. These initiatives were aimed at obtaining evidence about effective treatment options for mild asthma and providing consistent messaging for patients and clinicians across the spectrum of asthma severity. 4. From 2007, based on evidence that exacerbations were significantly reduced by low dose ICS–formoterol maintenance and reliever therapy in moderate–severe asthma [21] and, in a study by Papi et al. FitzGerald reports grants and personal fees for advisory board work and speaker bureau-related presentations from AstraZeneca, GSK and Sanofi Regeneron, grants from Novartis, Boehringer Ingelheim and TEVA, during the conduct of the study; and is a member of the Executive and Science Committees of GINA. The need for such studies was supported by the findings of the UK National Review of Asthma Deaths in 2014, that 9% of asthma deaths were in patients being treated with SABA alone (suggesting that their physician had considered they had mild asthma), and 39% were associated with excess prescriptions for SABA [23]. However, before choosing this option, the clinician should consider whether a patient is likely to be adherent with daily ICS, or default to SABA-only treatment with its attendant risks. Print 2019 Nov. JAMA Pediatr. The most fundamental change in asthma management in 30 years? The authors acknowledge with respect and gratitude the tireless work of Claude Lenfant and Suzanne Hurd for GINA, from its establishment in 1993 until their retirement in 2014, and of Rebecca Decker, the Global Program Director for GINA, since 2014. AU - Reddel, … Respir. Epub 2008 Apr 18. Although the public health implications of these major changes in GINA recommendations remain to be studied, their potential is great, both in economically developed countries and in low income countries where access to ICS-containing medications, particularly as maintenance therapy, is limited or non-existent. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. Brusselle G, Buhl R, Cruz AA, Fleming L, Inoue H et al. Conflict of interest: A. Becker reports personal fees for continuing medical education from AstraZeneca, personal fees for lecturing from Johnson and Johnson, and MSD, personal fees for advisory board work from Novartis, outside the submitted work. Cattani-Cavalieri I, da Maia Valença H, Moraes JA, Brito-Gitirana L, Romana-Souza B, Schmidt M, Valença SS. These include two open-label randomised controlled trials, representing the way that patients would use as-needed ICS–formoterol in real life [34, 35]; both of these studies include type 2 biomarkers at baseline and during treatment. 2020 Feb 6;55(2):1902043. doi: 10.1183/13993003.02043-2019. In addition, there was a paucity of evidence for feasible alternatives. a) Mild asthma … In parallel, extensive evidence emerged of the protective value of regular ICS, with a dramatic reduction in the risk of asthma-related hospitalisations and death [6, 7]. New recommendations from the Global Initiative for Asthma (GINA) were released in a pocket guide form on April 12, 2019. Print 2019 Nov. Conflict of interest: A. Becker reports personal fees for continuing medical education from AstraZeneca, personal fees for lecturing from Johnson and Johnson, and MSD, personal fees for advisory board work from Novartis, outside the submitted work. Here, we provide the background to these recommendations, summarise the evidence and rationale for the changes, and identify research gaps. 2020 Nov 7;18(1):22. doi: 10.1186/s12948-020-00137-2. Reddel HK, FitzGerald JM, Bateman ED, et al. NIH However, unusually among chronic diseases, patients with apparently mild asthma are over-represented in serious outcomes: 30–37% of adults with acute asthma, 16% of patients with near-fatal asthma, and 15–20% of adults dying of asthma had asthma symptoms less than weekly in the previous 3 months [33]. Levy is lead on asthma and joint lead for COPD in developing dashboards for clinical care for general practitioners in London, outside the submitted work. Louis-Philippe Boulet is Chair of the GINA Board; Helen K. Reddel is Chair of the GINA Science Committee; and Mark L. Levy is Chair of the GINA Dissemination and Implementation Committee. Levy reports personal fees for consultancy from Clement Clarke International, personal fees for lecturing from Teva and Soar Beyond, personal fees for advisory board work from AstraZeneca, Orion Pharmaceuticals, GlaxoSmithKline and Trudel Pharmaceuticals, non-financial (travel) support from and is a board member of GINA, personal fees for data monitoring committee work and travel support from Chiesi, grants from Conzorcio Futuro In Ricerca, support for meeting attendance from Napp Pharmaceuticals, personal fees for consultancy from National Services for Health Improvement, a company providing services for practices (Nurse asthma reviews), personal fees for lecturing and advisory board work from Novartis Pharmaceuticals, and support from Whole Systems Integrated Care (WSIC) for whom M.L. Which of the following statement is true concerning mild asthma? In making this recommendation, high importance was given to the weight of evidence that ICS reduces asthma-related deaths [6], and that it reduces exacerbations even in so-called “intermittent” asthma [26]. Conflict of interest: A. Sheikh reports support for meeting attendance from GSK, grants from Asthma UK, and other support from the Scottish Allergy and Respiratory Academy (a not-for-profit training initiative for health care professionals supported by a consortium of industry funders), outside the submitted work. Krishnan reports research grants from the US National Institutes of Health (current), research contracts from the US Patient Centered Outcomes Research Institute (current), and personal fees from Sanofi to serve on an independent data monitoring committee, outside the submitted work. In April 2019, the Global Initiative for Asthma (GINA) (box 1) published new recommendations that might be considered the most fundamental change in asthma management in … Response: The most fundamental change in asthma management in 30 years? GINA no longer recommends treating adults/adolescents with asthma with short-acting bronchodilators alone. T2 - a fundamental change in asthma management: Treatment of asthma with short-acting bronchodilators alone is no longer recommended for adults and adolescents. Sci Rep. 2021 Jan 12;11(1):724. doi: 10.1038/s41598-020-80815-y. New recommendations about treatment of mild asthma, described in the present report, represent the outcome of more than a decade of work by GINA members and others, and may be considered the … Conflict of interest: M.L. Ko has nothing to disclose. Several treatment options for achieving this are recommended in the GINA 2019 strategy report (figure 1). Online ISSN: 1399-3003, Copyright © 2021 by the European Respiratory Society. Regular ICS maintenance treatment has been around for more than 40 years. Spiral, Imperial College Digital Repository. GINA 2019: a fundamental change in asthma management: Treatment of asthma with short-acting bronchodilators alone is no longer recommended for adults and adolescents. 2019;53(6):1901046. Updated Australian guidelines for mild asthma: what's changed and why? Conflict of interest: A.A. Cruz reports grants and personal fees for advisory board work from GSK, grants, personal fees for lecturing and advisory board work and non-financial support for meeting attendance from AstraZeneca, personal fees for lecturing, developing educational materials and advisory board work, and non-financial support for meeting attendance from Boehringer Ingelheim, personal fees for lecturing and non-financial support for meeting attendance from Chiesi, personal fees for lecturing and developing educational materials, and non-financial support for meeting attendance from EUROFARMA and MEDA Pharma, personal fees for lecturing from Novartis, personal fees for consultancy and advisory board work from Sanofi, outside the submitted work. Currently, all of these as-needed strategies are technically “off-label”, as ICS, ICS–formoterol and ICS–SABA are indicated only for regular use in most countries. For Step 2 (for patients with symptoms twice a month or more, or with risk factors for exacerbations), the previous recommendation for daily low dose ICS remains. Q2. Exacerbations are infrequent events in mild asthma; in the closely monitored SYGMA 1 study, only 12% of patients receiving as-needed SABA experienced a severe exacerbation in 12 months [25]. The work of GINA is supported only by the sale and licensing of GINA reports and its other publications, and by the voluntary work of GINA committee members. Conflict of interest: M.L. Print 2020 Feb. Eur Respir J. GINA 2019: a fundamental change in asthma management: treatment of asthma with short-acting bronchodilators alone is no longer recommended for adults and adolescents. A description of GINA methodology is also available on the GINA website. 2015 Sep;53(9):102-4. doi: 10.1136/dtb.2015.9.0349. Head-to-head studies of as-needed ICS–formoterol and ICS–SABA are needed, to compare efficacy and safety. These recommendations provide very important changes to the management of asthma, especially regarding the treatment of intermittent and mild asthma… Int J Mol Sci. Bateman is a member of the Science Committee and Board of GINA; reports personal fees from ALK, AstraZeneca, Boehringer Ingelheim, Cipla, Menarini, Novartis, Orion, Regeneron, Sanofi Genzyme and Vectura, and grants to his institution from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi-Aventis and TEVA, outside the submitted work. The new guideline states that, for safety, “[Global Initiative for Asthma] no longer recommends treatment of asthma … Controller treatment for mild asthma represents a population-level risk reduction strategy, similar to treatment of hypertension or hypercholesterolaemia, where one cannot know whether any individual patient has avoided a serious outcome. Studies of airway hyperresponsiveness, and of the relationship between symptoms, lung function and use of ICS–formoterol reliever are needed, in order to understand the mechanism by which exacerbations are reduced. 2020 Feb 6;55(2):2000068. doi: 10.1183/13993003.00068-2020. When ICS–formoterol was used as-needed and pre-exercise, protection against exercise-induced bronchoconstriction was obtained, of similar magnitude to that obtained with regular ICS plus as-needed and pre-exercise SABA [27]. Krishnan reports research grants from the US National Institutes of Health (current), research contracts from the US Patient Centered Outcomes Research Institute (current), and personal fees from Sanofi to serve on an independent data monitoring committee, outside the submitted work. Conflict of interest: S.E. ICS: inhaled corticosteroids; SABA: short-acting β2-agonists; LTRA: leukotriene receptor antagonists; LABA: long-acting β2-agonists; OCS: oral corticosteroids; BDP: beclometasone dipropionate; HDM: house dust mite; SLIT: sublingual immunotherapy; FEV1: forced expiratory volume in 1 s; IL: interleukin. … Conflict of interest: R. Buhl reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Novartis, Roche, and Teva, outside the submitted work, as well as grants to Mainz University from Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Roche, also outside the submitted work. Multiple studies had demonstrated adverse effects of even short-term regular use of SABA alone, including reduced bronchoprotection and bronchodilator response, increased airway hyperresponsiveness, exercise-induced bronchoconstriction and allergic responses, and increased eosinophilic inflammation and mast cell mediator release [10, 11]. 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