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Management of Severe Asthma: a European Respiratory Society/American Thoracic Society Guideline

Fernando Holguin, Juan Carlos Cardet, Kian Fan Chung, Sarah Diver, Diogenes S. Ferreira, Anne Fitzpatrick, Mina Gaga, Liz Kellermeyer, Sandhya Khurana, Shandra Knight, Vanessa M. McDonald, Rebecca L. Morgan, Victor E. Ortega, David Rigau, Padmaja Subbarao, Thomy Tonia, Ian M. Adcock, Eugene R. Bleecker, Chris Brightling, Louis-Philippe Boulet, Michael Cabana, Mario Castro, Pascal Chanez, Adnan Custovic, Ratko Djukanovic, Urs Frey, Betty Frankemolle, Peter Gibson, Dominique Hamerlijnck, Nizar Jarjour, Satoshi Konno, Huahao Shen, Cathy Vitary, Andy Bush
European Respiratory Journal 2019; DOI: 10.1183/13993003.00588-2019
Fernando Holguin
1University of Colorado, Pulmonary Sciences and Critical Care Medicine, Denver, CO, USA
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  • For correspondence: fernando.holguin@ucdenver.edu
Juan Carlos Cardet
2University of South Florida, Allergy and Immunology, Tampa, FL, USA
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Kian Fan Chung
3Experimental Studies Medicine, Imperial College London, National Heart & Lung Institute, London, UK
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Sarah Diver
4University of Leicester, Respiratory Biomedical Unit, Leicester, UK
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Diogenes S. Ferreira
5Alergia e Imunologia, Complexo Hospital de Clinicas, Universidade Federal do Parana, Curitiba, Brazil
6School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
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Anne Fitzpatrick
7Emory University, Division of Pulmonology Allergy/Immunology, Cystic Fibrosis and Sleep, Atlanta, GA, USA
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Mina Gaga
8Athens Chest Hospital, Respiratory Medicine Department and Asthma Centre, Athens, Greece
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Liz Kellermeyer
9Biomedical Library, National Jewish Health, Denver, CO, USA
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Sandhya Khurana
10Pulmonary Diseases and Critical Care, University of Rochester, Rochester, NY, USA
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Shandra Knight
11Biomedical Library, National Jewish Health, Denver, CO, USA
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Vanessa M. McDonald
12School of Nursing, University of Newcastle, Newcastle, Australia
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Rebecca L. Morgan
13Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada
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Victor E. Ortega
14Pulmonary, Critical Care, Allergy and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, NC, USA
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David Rigau
15Iberoamerican Cochrane Centre, Barcelona, Spain
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Padmaja Subbarao
16Department of Pediatrics, SickKids, Toronto, Ontario, Canada
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Thomy Tonia
17Institute of Social and Preventive Medicine, University of Bern, Switzerland
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Ian M. Adcock
18Department of Molecular Cell Biology, Imperial College of London, National Heart & Lung Institute, London, UK
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Eugene R. Bleecker
19Division of Genetics, Genomics and Precision Medicine, University of Arizona, Tucson, Arizona
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Chris Brightling
20Department of Respiratory Sciences, University of Leicester, Leicester, UK
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Louis-Philippe Boulet
21Respiratory Medicine, Laval University, Quebec, Canada
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Michael Cabana
22Division of General Pediatrics, University of California San Francisco, SF, USA
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Mario Castro
23Division of Pulmonary and Critical Care Medicine, Washington University, St. Louis, MO, USA
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Pascal Chanez
24Department of Respiratory Diseases, University of Aix-Marseille, Marseille, France
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Adnan Custovic
25Paediatric Allergy, Imperial College of London, National Heart & Lung Institute, London, UK
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Ratko Djukanovic
26Respiratory Biomedical Research, University of Southampton, Southampton, UK
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Urs Frey
27Department of Pediatrics, University Children's Hospital, Basel, Switzerland
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Betty Frankemolle
28European Lung Foundation, Lausanne, Switzerland
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Peter Gibson
29School of Medicine and Public Health, University of New Castle, New Castle, Australia
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Dominique Hamerlijnck
28European Lung Foundation, Lausanne, Switzerland
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Nizar Jarjour
30Division of Pulmonary and Critical Care, University of Wisconsin, Madison, WI, USA
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Satoshi Konno
31Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Hokkaido, Japan
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Huahao Shen
34Department of Respiratory and Critical Care Medicine, The second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China
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Cathy Vitary
32Asthma Institute, University of Pittsburgh, Pittsburgh, PA, USA
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Andy Bush
33Department of Paediatrics, National Heart & Lung Institute, Imperial College London, London, UK
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Abstract

This document provides clinical recommendations for the management of severe asthma. Comprehensive evidence syntheses, including meta-analyses, were performed to summarise all available evidence relevant to the Task Force's questions. The evidence was appraised using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach and the results were summarised in evidence profiles. The evidence syntheses were discussed and recommendations formulated by a multidisciplinary Task Force of asthma experts, who made specific recommendations on 6 specific questions. After considering the balance of desirable and undesirable consequences, quality of evidence, feasibility, and acceptability of various interventions, the Task Force made the following recommendations: 1) Suggest using anti-IL5 and anti IL-5Rα for severe uncontrolled adult eosinophilic asthma phenotypes; 2) suggest using blood eosinophil cut-point of ≥150/μL to guide anti-IL5 initiation in adult patients with severe asthma; and 3) Suggest considering specific eosinophil (≥260/μL) and FeNO (≥19.5 ppb) cutoffs to identify adolescents or adults with the greatest likelihood or response to anti-IgE therapy; 4) Suggest using inhaled tiotropium for adolescents and adults with severe uncontrolled asthma despite GINA step 4–5 or NAEPP step 5 therapies; 5) Suggest a trial of chronic macrolide therapy to reduce asthma exacerbations in persistently symptomatic or uncontrolled patients on GINA step 5 or NAEPP step 5 therapies, irrespective of asthma phenotype; 6) Suggest using anti-IL4/13 for adult patients with severe eosinophilic asthma, and for those with severe corticosteroid-dependent asthma regardless of blood eosinophil levels. These recommendations should be reconsidered as new evidence becomes available.

Footnotes

This 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: Dr. Holguin has nothing to disclose.

Conflict of interest: KFC has received honoraria for participating in Advisory Board meetings of GSK, AZ, Novartis, Merck, BI, 4D, Pieris and TEVA regarding treatments for asthma, cough and chronic obstructive pulmonary disease and has also been renumerated for speaking engagements.

Conflict of interest: Dr. Diver has nothing to disclose.

Conflict of interest: Dr. Ferreira reports Fellowship MTF 2015-02 from European Respiratory Society, during the conduct of the study.

Conflict of interest: Dr. Fitzpatrick has nothing to disclose.

Conflict of interest: Dr. Gaga reports grants and personal fees from Astra-Zeneca, grants from Novartis, grants from Menarini, grants from Elpen, grants and personal fees from Chiesi, personal fees from MSD, personal fees from BMS, outside the submitted work; .

Conflict of interest: Ms. Kellermeyer has nothing to disclose.

Conflict of interest: Dr. Khurana reports grants from GlaxoSmithKline and Sanofi, outside the submitted work.

Conflict of interest: Ms. Knight has nothing to disclose.

Conflict of interest: Dr. McDonald reports grants from GSK, grants and personal fees from AZ, personal fees from Menarini, outside the submitted work.

Conflict of interest: Dr. Morgan has nothing to disclose.

Conflict of interest: Dr. Ortega has nothing to disclose.

Conflict of interest: Dr. Rigau reports and declares he works as methodologist of the ERS.

Conflict of interest: Dr. Subbarao has nothing to disclose.

Conflict of interest: Dr. Tonia acts as ERS methodologist.

Conflict of interest: Dr. Adcock has nothing to disclose.

Conflict of interest: Dr. Bleecker reports other from ERB has undertaken clinical trials through his employer, Wake Forest School of Medicine and University of Arizona, for AstraZeneca, MedImmune, Boehringer Ingelheim, Genentech, Johnson and Johnson (Janssen), Novartis, Regeneron, and Sanofi Genzyme, personal fees from ERB has also served as a paid consultant for AztraZeneca, MedImmune, Boehringer Ingelheim, Glaxo Smith Kline, Novartis, Regeneron, and Sanofi Genzyme, outside the submitted work; .

Conflict of interest: Dr. brightling reports grants and personal fees from GSK, grants and personal fees from Novartis, grants and personal fees from Genentech/Roche, grants and personal fees from Chiesi, personal fees from Sanofi/Regeneron, grants and personal fees from 4DPharma, grants and personal fees from Glenmark, grants and personal fees from BI, grants and personal fees from Mologic, grants and personal fees from Gossamer, grants and personal fees from AZ/MedImmune, personal fees from TEVA, outside the submitted work; .

Conflict of interest: Dr. Boulet reports Research grants for participation to multicentre studies AstraZeneca, Boston Scientific, GlaxoSmithKline, Hoffman La Roche, Novartis, Ono Pharma, Sanofi, Takeda. Support for research projects submitted by the investigator AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Merck, Takeda. Consulting and advisory boards Astra Zeneca, GSK, Novartis, Methapharm. Nonprofit grants for production of educational materials AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Merck Frosst, Novartis. Conference fees AstraZeneca, GlaxoSmithKline, Merck, Novartis. Support for participation in conferences and meetings Novartis, Takeda..

Conflict of interest: Dr. CABANA reports personal fees from GENENTECH, personal fees from NOVARTIS, outside the submitted work; .

Conflict of interest: Dr. Castro receives University Grant Funding from NIH, American Lung Association, PCORI. He receives Pharmaceutical Grant Funding from AstraZeneca, Boeringer Ingelheim, Chiesi, GSK, Novartis, Sanofi Aventis. He is a consultant for Aviragen, Boston Scientific, Genentech, Nuvaira, Neutronic, Therabron, Theravance, Vectura, 4D Pharma, VIDA, Mallinckrodt, Teva, Sanofi-Aventis. He is a speaker for Astra-Zeneca, Boeringer Ingelheim, Boston Scientific, Genentech, Regeneron, Sanofi, Teva. He receives royalties from Elsevier.

Conflict of interest: Pascal Chanez PC had Consultancy services for Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Novartis, Teva, Chiesi, Sanofi and SNCF

Served on advisory boards for Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Novartis, Teva, Chiesi, and Sanofi

Received lecture fees from GlaxoSmithKline, AstraZeneca, Novartis, Teva, Chiesi, Boston Scientific and ALK

Received industry-sponsored grants from, AstraZeneca, ALK, Novartis.

Conflict of interest: Dr. Custovic reports personal fees from Novartis, personal fees from Regeneron / Sanofi, personal fees from Thermo Fisher Scientific, personal fees from Boehringer Ingelheim, personal fees from Novartis, personal fees from Philips, outside the submitted work.

Conflict of interest: Dr Djukanovic reports receiving fees for lectures at symposia organised by Novartis, AstraZeneca and TEVA, consultation for TEVA and Novartis as member of advisory boards, and participation in a scientific discussion about asthma organised by GlaxoSmithKline. He is a co-founder and current consultant, and has shares in Synairgen, a University of Southampton spin out company.

Conflict of interest: Dr. Frey reports personal fees from GSK Scientific Advisory Board, outside the submitted work; .

Conflict of interest: Dr. Frankemölle has nothing to disclose.

Conflict of interest: Dr. Gibson reports grants and personal fees from Glaxosmithkline, grants and personal fees from Astrazeneca, personal fees from Novartis, Sanofi, outside the submitted work; .

Conflict of interest: Dr. Hamerlijnck reports and Independent European Federation of Allergy and Airways (EFA) patient advisor to NOVARTIS Chief medical officer on patient involvment.

Conflict of interest: Dr. Jarjour reports personal fees from Astra Zeneca , personal fees from Boehringer Ingelheim, during the conduct of the study; and N.N. Jarjour reports receiving the following, outside the submitted work: a grant from National

Conflict of interest: Dr. Konno reports grants from Astra Zeneka, grants from KYORIN Pharmaceutical Co. Ltd, grants from Japan Allergy Foundation, grants from Novartis, grants from Ministry of Education, Culture, Sports, Science and Technology of Japan, during the conduct of the study; .

Conflict of interest: Dr. Shen has nothing to disclose.

Conflict of interest: Dr. Bush has nothing to disclose.

Conflict of interest: Ms. Vitari has nothing to disclose.

Conflict of interest: Dr. Cardet has nothing to disclose.

Conflict of interest: PC had Consultancy services for Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Novartis, Teva, Chiesi, Sanofi and SNCF?Served on advisory boards for Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Novartis, Teva, Chiesi, and SanofiReceived lecture fees from GlaxoSmithKline, AstraZeneca, Novartis, Teva, Chiesi, Boston Scientific and ALK?Received industry-sponsored grants from, AstraZeneca, ALK, Novartis.

This is a PDF-only article. Please click on the PDF link above to read it.

  • Received April 13, 2019.
  • Accepted August 8, 2019.
  • Copyright ©ERS 2019
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Management of Severe Asthma: a European Respiratory Society/American Thoracic Society Guideline
Fernando Holguin, Juan Carlos Cardet, Kian Fan Chung, Sarah Diver, Diogenes S. Ferreira, Anne Fitzpatrick, Mina Gaga, Liz Kellermeyer, Sandhya Khurana, Shandra Knight, Vanessa M. McDonald, Rebecca L. Morgan, Victor E. Ortega, David Rigau, Padmaja Subbarao, Thomy Tonia, Ian M. Adcock, Eugene R. Bleecker, Chris Brightling, Louis-Philippe Boulet, Michael Cabana, Mario Castro, Pascal Chanez, Adnan Custovic, Ratko Djukanovic, Urs Frey, Betty Frankemolle, Peter Gibson, Dominique Hamerlijnck, Nizar Jarjour, Satoshi Konno, Huahao Shen, Cathy Vitary, Andy Bush
European Respiratory Journal Jan 2019, 1900588; DOI: 10.1183/13993003.00588-2019

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Management of Severe Asthma: a European Respiratory Society/American Thoracic Society Guideline
Fernando Holguin, Juan Carlos Cardet, Kian Fan Chung, Sarah Diver, Diogenes S. Ferreira, Anne Fitzpatrick, Mina Gaga, Liz Kellermeyer, Sandhya Khurana, Shandra Knight, Vanessa M. McDonald, Rebecca L. Morgan, Victor E. Ortega, David Rigau, Padmaja Subbarao, Thomy Tonia, Ian M. Adcock, Eugene R. Bleecker, Chris Brightling, Louis-Philippe Boulet, Michael Cabana, Mario Castro, Pascal Chanez, Adnan Custovic, Ratko Djukanovic, Urs Frey, Betty Frankemolle, Peter Gibson, Dominique Hamerlijnck, Nizar Jarjour, Satoshi Konno, Huahao Shen, Cathy Vitary, Andy Bush
European Respiratory Journal Jan 2019, 1900588; DOI: 10.1183/13993003.00588-2019
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