TY - JOUR
T1 - Defining a Severe Asthma Super-Responder
T2 - Findings from a Delphi Process
AU - Upham, John W.
AU - Le Lievre, Chantal
AU - Jackson, David J.
AU - Masoli, Matthew
AU - Wechsler, Michael E.
AU - Price, David B.
AU - Mansur, Adel
AU - Detoraki, Aikaterini
AU - Altraja, Alan
AU - James, Alan
AU - Nanzer-Kelly, Alexandra
AU - Côté, Andréanne
AU - Menzies-Gow, Andrew
AU - Papaioannou, Andriana
AU - Cheffins, Anne Maree
AU - Bourdin, Arnaud
AU - Mahboub, Bassam
AU - Lipworth, Brian
AU - Celis-Preciado, Carlos Andrés
AU - Torres-Duque, Carlos
AU - Bucca, Caterina
AU - Porsbjerg, Celeste
AU - Ulrik, Charlotte
AU - Corrigan, Chris
AU - Taube, Christian
AU - Farah, Claude
AU - Katelaris, Constance
AU - Langton, David
AU - Ryan, Dermot
AU - Larenas-Linnemann, Désirée
AU - Zervas, Eleftherios
AU - Heffler, Enrico
AU - Hoyte, Flavia
AU - Puggioni, Francesca
AU - Christoff, George
AU - Canonica, Giorgio Walter
AU - Carpagnano, Giovanna Elisiana
AU - Guida, Giuseppe
AU - Katsoulotos, Gregory
AU - Brusselle, Guy
AU - Rupani, Hitashi
AU - Jersmann, Hubertus
AU - Clifton, Ian
AU - Dhariwal, Jaideep
AU - Fingleton, James
AU - Duke, Jane
AU - Rimmer, Janet
AU - Douglass, Jo
AU - Fonseca, João
AU - Fowler, Stephen
N1 - Funding Information:
Conflicts of interest: J.W. Upham reports personal fees from AstraZeneca, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, and Novartis, outside the submitted work. D.J. Jackson reports personal fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Teva, Napp, Chiesi, and Novartis; and grants from AstraZeneca , outside the submitted work. M. Masoli reports personal fees from Novartis and AstraZeneca, outside the submitted work. M.E. Wechsler reports grants and personal fees from Novartis , Sanofi , and Cohero Health ; personal fees from Regeneron, Genentech, Sentien, Restorbio, Equillium, and Genzyme; grants, personal fees, and nonfinancial support from Teva and AstraZeneca ; personal fees and nonfinancial support from Boehringer Ingelheim ; and personal fees from GSK, outside the submitted work. D.B. Price reports grants from AKL Research and Development Ltd , British Lung Foundation , Respiratory Effectiveness Group , and UK National Health Service ; grants and personal fees from AstraZeneca , Boehringer Ingelheim , Chiesi , Mylan , Novartis , Regeneron Pharmaceuticals , Sanofi Genzyme , Theravance , Zentiva (Sanofi Generics); personal fees from Cipla, GlaxoSmithKline, Kyorin, Merck, Mundipharma, Airway Vista Secretariat, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L, Talos Health Solutions, and WebMD Global LLC, outside the submitted work; nonfinancial support from Efficacy and Mechanism Evaluation programme and Health Technology Assessment; and stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and 5% shareholding in Timestamp, which develops adherence monitoring technology. The rest of the authors declare that they have no relevant conflicts of interest.
Funding Information:
This project was supported by in kind contributions from the Observational and Pragmatic Research Institute and the University of Queensland Faculty of Medicine . No pharmaceutical companies were involved in the study design or execution.
Funding Information:
This project was supported by in kind contributions from the Observational and Pragmatic Research Institute and the University of Queensland Faculty of Medicine. No pharmaceutical companies were involved in the study design or execution.Conflicts of interest: J.W. Upham reports personal fees from AstraZeneca, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, and Novartis, outside the submitted work. D.J. Jackson reports personal fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Teva, Napp, Chiesi, and Novartis; and grants from AstraZeneca, outside the submitted work. M. Masoli reports personal fees from Novartis and AstraZeneca, outside the submitted work. M.E. Wechsler reports grants and personal fees from Novartis, Sanofi, and Cohero Health; personal fees from Regeneron, Genentech, Sentien, Restorbio, Equillium, and Genzyme; grants, personal fees, and nonfinancial support from Teva and AstraZeneca; personal fees and nonfinancial support from Boehringer Ingelheim; and personal fees from GSK, outside the submitted work. D.B. Price reports grants from AKL Research and Development Ltd, British Lung Foundation, Respiratory Effectiveness Group, and UK National Health Service; grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Theravance, Zentiva (Sanofi Generics); personal fees from Cipla, GlaxoSmithKline, Kyorin, Merck, Mundipharma, Airway Vista Secretariat, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L, Talos Health Solutions, and WebMD Global LLC, outside the submitted work; nonfinancial support from Efficacy and Mechanism Evaluation programme and Health Technology Assessment; and stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and 5% shareholding in Timestamp, which develops adherence monitoring technology. The rest of the authors declare that they have no relevant conflicts of interest.
Publisher Copyright:
© 2021 American Academy of Allergy, Asthma & Immunology
PY - 2021/11
Y1 - 2021/11
N2 - Background: Clinicians are increasingly recognizing severe asthma patients in whom biologics and other add-on therapies lead to dramatic improvement. Currently, there is no agreed-upon super-responder (SR) definition.Objective: To survey severe asthma experts using a modified Delphi process, to develop an international consensus-based definition of a severe asthma SR.Methods: The Delphi panel was composed of 81 participants (94% specialist pulmonologists or allergists) from 24 countries and consisted of three iterative online voting rounds. Consensus on individual items, whether acceptance or rejection, required at least 70% agreement by panel members.Results: Consensus was achieved that the SR definition should be based on improvement across three or more domains assessed over 12 months. Major SR criteria included exacerbation elimination, a large improvement in asthma control (two or more times the minimal clinically important difference), and cessation of maintenance of oral steroids (or weaning to adrenal insufficiency). Minor SR criteria were composed of a 75% exacerbation reduction, having well-controlled asthma, and 500 mL or greater improvement in FEV1. The SR definition requires improvement in at least two major criteria. In the future, the SR definition should be expanded to incorporate quality of life measures, although current tools can be difficult to implement in a clinical setting and further research is needed.Conclusions: This international consensus-based definition of severe asthma SRs is an important prerequisite for better understanding SR prevalence, predictive factors, and the mechanisms involved. Further research is needed to understand the patient's perspective and to measure quality of life more precisely in SRs.
AB - Background: Clinicians are increasingly recognizing severe asthma patients in whom biologics and other add-on therapies lead to dramatic improvement. Currently, there is no agreed-upon super-responder (SR) definition.Objective: To survey severe asthma experts using a modified Delphi process, to develop an international consensus-based definition of a severe asthma SR.Methods: The Delphi panel was composed of 81 participants (94% specialist pulmonologists or allergists) from 24 countries and consisted of three iterative online voting rounds. Consensus on individual items, whether acceptance or rejection, required at least 70% agreement by panel members.Results: Consensus was achieved that the SR definition should be based on improvement across three or more domains assessed over 12 months. Major SR criteria included exacerbation elimination, a large improvement in asthma control (two or more times the minimal clinically important difference), and cessation of maintenance of oral steroids (or weaning to adrenal insufficiency). Minor SR criteria were composed of a 75% exacerbation reduction, having well-controlled asthma, and 500 mL or greater improvement in FEV1. The SR definition requires improvement in at least two major criteria. In the future, the SR definition should be expanded to incorporate quality of life measures, although current tools can be difficult to implement in a clinical setting and further research is needed.Conclusions: This international consensus-based definition of severe asthma SRs is an important prerequisite for better understanding SR prevalence, predictive factors, and the mechanisms involved. Further research is needed to understand the patient's perspective and to measure quality of life more precisely in SRs.
KW - Asthma
KW - Asthma treatment
KW - Biologics
UR - http://www.scopus.com/inward/record.url?scp=85111291256&partnerID=8YFLogxK
U2 - 10.1016/j.jaip.2021.06.041
DO - 10.1016/j.jaip.2021.06.041
M3 - Article
C2 - 34271216
AN - SCOPUS:85111291256
SN - 2213-2198
VL - 9
SP - 3997
EP - 4004
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 11
ER -