RT Journal Article SR Electronic T1 Global Initiative for Asthma (GINA) Strategy 2021 - Executive summary and rationale for key changes JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP 2102730 DO 10.1183/13993003.02730-2021 A1 Helen K. Reddel A1 Leonard B. Bacharier A1 Eric D. Bateman A1 Christopher E. Brightling A1 Guy G. Brusselle A1 Roland Buhl A1 Alvaro A. Cruz A1 Liesbeth Duijts A1 Jeffrey M. Drazen A1 J. Mark FitzGerald A1 Louise J. Fleming A1 Hiromasa Inoue A1 Fanny W. Ko A1 Jerry A. Krishnan A1 Mark L. Levy A1 Jiangtao Lin A1 Kevin Mortimer A1 Paulo M. Pitrez A1 Aziz Sheikh A1 Arzu A. Yorgancioglu A1 Louis-Philippe Boulet YR 2021 UL http://erj.ersjournals.com/content/early/2021/10/14/13993003.02730-2021.abstract AB The Global Initiative for Asthma (GINA) Strategy Report provides clinicians with an annually updated evidence-based strategy for asthma management and prevention, which can be adapted for local circumstances (e.g., medication availability). This article summarizes key recommendations from GINA 2021, and the evidence underpinning recent changes.GINA recommends that asthma in adults and adolescents should not be treated solely with short-acting beta2-agonist (SABA), because of the risks of SABA-only treatment and SABA overuse, and evidence for benefit of inhaled corticosteroids (ICS). Large trials show that as- needed combination ICS-formoterol reduces severe exacerbations by >60% in mild asthma compared with SABA alone, with similar exacerbation, symptom, lung function and inflammatory outcomes as daily ICS plus as-needed SABA.Key changes in GINA 2021 include division of the treatment figure for adults and adolescents into two tracks. Track 1 (preferred) has low-dose ICS-formoterol as the reliever at all steps: as-needed only in Steps 1-2 (mild asthma), and with daily maintenance ICS-formoterol (maintenance-and-reliever therapy, MART) in Steps 3-5. Track 2 (alternative) has as-needed SABA across all steps, plus regular ICS (Step 2) or ICS-long-acting beta2-agonist (LABA) (Steps 3-5). For adults with moderate-to-severe asthma, GINA makes additional recommendations in Step 5 for add-on long-acting muscarinic antagonists and azithromycin, with add-on biologic therapies for severe asthma. For children 6-11  years, new treatment options are added at Steps 3-4.Across all age-groups and levels of severity, regular personalized assessment, treatment of modifiable risk factors, self-management education, skills training, appropriate medication adjustment and review remain essential to optimize asthma outcomes.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Leonard B. Bacharier reports receiving royalties for textbooks from Elsevier; consulting fees from GlaxoSmithKline, Teva, AstraZeneca, Sanofi, Regeneron, Vectura, Circassia, Kinaset, Merck and Boehringer Ingelheim; honoraria for lectures from GlaxoSmithKline, Genentech/Novartis, Teva Honoraria, AstraZeneca, Sanofi/Regeneron and WebMD/Medscape; participation on a Data Safety Monitoring Board or Advisory Board for DBV Technologies, AstraZeneca and Vertex (CF Foundation); leadership or fiduciary roles in other board, society, committee or advocacy group, paid or unpaid for AAAAI Board of Directors (unpaid) and ABAI Board of Directors, in the past 36 months.Conflict of interest: Eric D. Bateman reports receiving advisory boards, consultant and speaker fees from AstraZeneca, Sanofi Genzyme, Regeneron, Novartis and ALK; speaker fees from Boehringer Ingelheim, Menarini and Orion; and advisory boards and speaker fees from Chiesi, since the initial planning of this work. Eric D. Bateman reports receiving consulting fees from AstraZeneca, Sanofi Genzyme, Regeneron, Novartis and ALK; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Menarini, Orion, Novartis, Regeneron, Sanofi Genzyme, Chiesi and ALK; support for attending meetings and/or travel from Novartis (to attend European Respiratory Society Congress 2021); participation on a Data Safety Monitoring Board or Advisory Board from AstraZeneca, ALK, Sanofi Genzyme, Regeneron, Novartis and Chiesi; leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid for Global Initiative for Asthma (Member of Board and Science Committee, unpaid), in the past 36 months.Conflict of interest: Christopher E. Brightling reports receiving grants or contracts from GSK, AZ, Novartis, Chiesi, BI, Mologic, 4DPharma, Gossamer, Merck and Roche/Genentech (all paid to Institution); consulting fees from AZ, Novartis, Chiesi, BI, Mologic, TEVA, 4DPharma, Gossamer, Regeneron, Sanofi and Roche/Genentech (all paid to Institution), in the past 36 months.Conflict of interest: Guy G. Brusselle reports receiving payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi and Teva; participation on a Data Safety Monitoring Board or Advisory Board for AstraZeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, MSD, Novartis, Sanofi and Teva, in the past 36 months.Conflict of interest: Roland Buhl reports grants from Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Roche; lecture honoraria from AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Novartis, Roche, Sanofi, Teva; participation on advisory board from AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Roche, Sanofi, Teva; outside the submitted work; and has acted as a Member of the Scientific Committee of the Global Initiative for Asthma (GINA).Conflict of interest: Alvaro A. Cruz reports lecture honoraria from Abdi Ibrahim, AstraZeneca, Boehringer Ingelheim, Chiesi, Glennmark, GSK, Mylan, Novartis, Sanofi; travel support from AstraZeneca; Boehringer Ingelheim; Chiesi; outside the submitted work.Conflict of interest: Liesbeth Duijts reports grants from European Union's Horizon 2020 research and innovation programme (LIFECYCLE, grant agreement No 733206, 2016; EUCAN-Connect grant agreement No 824989; ATHLETE, grant agreement No 874583), outside the submitted work.Conflict of interest: J. Mark FitzGerald reports grants from Astra Zeneca, GSK, TEVA, SANOFI, CIHR, NIH; consulting fees and lecture honoraria from Astra Zeneca, GSK, TEVA, SANOFI; outside the submitted work.Conflict of interest: Louise J. Fleming reports consulting fees from GSK, Sanofi, Respiri UK, Astra Zeneca; lecture honoraria from Novartis, Teva; outside the submitted work.Conflict of interest: Hiromasa Inoue reports grants to institution to Boehringer-Ingelheim, GlaxoSmithKline, Kyorin, MerckSharp&Dohme, Ono; personal consulting fees from Boehringer-Ingelheim; lecture honoraria from AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Kyorin, MerckSharp&Dohme, Novartis, Sanofi; has participated on an advisory board for AstraZeneca, GlaxoSmithKline, Novartis, Sanofi; board leadership with Board of Directors & Chairman of Education Committee in Japanese Respiratory Society, Former Chairman of Education Committee in Japanese Society of Allergology; outside the submitted work.Conflict of interest: Fanny W. Ko reports support for travel from Novartis, Boehringer Ingelheim and GSK, outside the submitted work.Conflict of interest: Jerry A. Krishnan reports grants from Regeneron Pharmaceuticals, Sergey Brin Family Foundation, Patient Centered Outcomes Research Institute, COPD Foundation, American Lung Association; consulting fees from GlaxoSmithKline for COVID-19 mAb; board leadership at COPD Foundation, Respiratory Health Association; outside the submitted work.Conflict of interest: Mark L. Levy reports grants from Consorzio Futuro in Ricerca, Astra Zeneca; royalties from Class Publishing, Taylor & Francis; consulting fees from Respiri, Ltd, TEVA, NSHI Ltd; lecture honoraria from TEVA, Novartis, Chiesi, Orion; payment for expert testimony from HM Coroner Walthamstow, London, HM Coroner, Waltham Forrest, London; travel support from Orion Pharmaceuticals, Menarini Pharmaceuticals, Napp Pharmaceuticals, TEVA; participation on advisory board at Chiesi, Novartis, GSK, Sandoz; and board leadership at Board of Directors, GINA, outside the submitted work.Conflict of interest: Kevin Mortimer participated as member of Advisory Boards for AstraZeneca, outside the submitted work.Conflict of interest: Paulo Pitrez reports consulting fees and lecture honoraria from AstraZeneca, Boehringer Ingelheim, GSK, Sanofi, and Novartis; travel support from GSK and Boehringer Ingelheim; and held an unpaid position as President of the Brazilian Severe Asthma Group; outside the submitted work.Conflict of interest: Helen K. Reddel reports grants from AstraZeneca, GlaxoSmithKline, Novartis; consulting fees from Novartis; lecture payments from AstraZeneca, GlaxoSmithKline, Teva, Boehringer Ingelheim, Sanofi, Chiesi; participation on advisory boards for AstraZeneca, GlaxoSmithKline, Novartis, Chiesi, Sanofi; acted as Chair of Scientific Committee and Member of Board of Directors for Global Initiative for Asthma, and acted as Member of Australian Asthma Guidelines Committee for National Asthma Council; outside the submitted work.Conflict of interest: Aziz Sheikh reports grants from HDRUK BREATHE Hub, Asthma UK Centre for Applied Research; and participated in the AstraZeneca Unmet Asthma Need Working Group; outside the submitted work.Conflict of interest: Arzu A. Yorgancioglu reports grants from MSD, Astra Zeneca, Sanofi, Novartis; consulting fees from AstraZeneca, GSK, Novartis, Sanofi, Chiesi, Deva; lecture honoraria from Astra Zeneca, Abdi İbrahim, GSK, Novartis, Sandoz, Chiesi, Vem İlaç; advisory board participation from GSK, Astra Zeneca; outside the submitted work.