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Standardization of clinical outcomes used in allergen immunotherapy in allergic asthma : An EAACI position paper

Kappen, Jasper ; Diamant, Zuzana LU ; Agache, Ioana ; Bonini, Matteo ; Bousquet, Jean ; Canonica, G. Walter ; Durham, Stephen R. ; Guibas, George V. ; Hamelmann, Eckard and Jutel, Marek , et al. (2023) In Allergy: European Journal of Allergy and Clinical Immunology 78(11). p.2835-2850
Abstract

Introduction: In allergic asthma patients, one of the more common phenotypes might benefit from allergen immunotherapy (AIT) as add-on intervention to pharmacological treatment. AIT is a treatment with disease-modifying modalities, the evidence for efficacy is based on controlled clinical trials following standardized endpoint measures. However, so far there is a lack of a consensus for asthma endpoints in AIT trials. The aim of a task force (TF) of the European Academy of Allergy and Clinical Immunology (EAACI) is evaluating several outcome measures for AIT in allergic asthma. Methods: The following domains of outcome measures in asthmatic patients have been evaluated for this position paper (PP): (i) exacerbation rate, (ii) lung... (More)

Introduction: In allergic asthma patients, one of the more common phenotypes might benefit from allergen immunotherapy (AIT) as add-on intervention to pharmacological treatment. AIT is a treatment with disease-modifying modalities, the evidence for efficacy is based on controlled clinical trials following standardized endpoint measures. However, so far there is a lack of a consensus for asthma endpoints in AIT trials. The aim of a task force (TF) of the European Academy of Allergy and Clinical Immunology (EAACI) is evaluating several outcome measures for AIT in allergic asthma. Methods: The following domains of outcome measures in asthmatic patients have been evaluated for this position paper (PP): (i) exacerbation rate, (ii) lung function, (iii) ICS withdrawal, (iv) symptoms and rescue medication use, (v) questionnaires (PROMS), (vi) bronchial/nasal provocation, (vii) allergen exposure chambers (AEC) and (viii) biomarkers. Results: Exacerbation rate can be used as a reliable objective primary outcome; however, there is limited evidence due to different definitions of exacerbation. The time after ICS withdrawal to first exacerbation is considered a primary outcome measure. Besides, the advantages and disadvantages and clinical implications of further domains of asthma endpoints in AIT trials are elaborated in this PP. Conclusion: This EAACI-PP aims to highlight important aspects of current asthma measures by critically evaluating their applicability for controlled trials of AIT.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
allergen immunotherapy, allergy, asthma, clinical outcomes, subcutaneous, sublingual
in
Allergy: European Journal of Allergy and Clinical Immunology
volume
78
issue
11
pages
2835 - 2850
publisher
Wiley-Blackwell
external identifiers
  • pmid:37449468
  • scopus:85165266586
ISSN
0105-4538
DOI
10.1111/all.15817
language
English
LU publication?
yes
id
08039c3f-fe93-4ca5-afc3-078e7cfef4fb
date added to LUP
2023-09-27 11:15:28
date last changed
2024-04-19 01:43:03
@article{08039c3f-fe93-4ca5-afc3-078e7cfef4fb,
  abstract     = {{<p>Introduction: In allergic asthma patients, one of the more common phenotypes might benefit from allergen immunotherapy (AIT) as add-on intervention to pharmacological treatment. AIT is a treatment with disease-modifying modalities, the evidence for efficacy is based on controlled clinical trials following standardized endpoint measures. However, so far there is a lack of a consensus for asthma endpoints in AIT trials. The aim of a task force (TF) of the European Academy of Allergy and Clinical Immunology (EAACI) is evaluating several outcome measures for AIT in allergic asthma. Methods: The following domains of outcome measures in asthmatic patients have been evaluated for this position paper (PP): (i) exacerbation rate, (ii) lung function, (iii) ICS withdrawal, (iv) symptoms and rescue medication use, (v) questionnaires (PROMS), (vi) bronchial/nasal provocation, (vii) allergen exposure chambers (AEC) and (viii) biomarkers. Results: Exacerbation rate can be used as a reliable objective primary outcome; however, there is limited evidence due to different definitions of exacerbation. The time after ICS withdrawal to first exacerbation is considered a primary outcome measure. Besides, the advantages and disadvantages and clinical implications of further domains of asthma endpoints in AIT trials are elaborated in this PP. Conclusion: This EAACI-PP aims to highlight important aspects of current asthma measures by critically evaluating their applicability for controlled trials of AIT.</p>}},
  author       = {{Kappen, Jasper and Diamant, Zuzana and Agache, Ioana and Bonini, Matteo and Bousquet, Jean and Canonica, G. Walter and Durham, Stephen R. and Guibas, George V. and Hamelmann, Eckard and Jutel, Marek and Papadopoulos, Nikolaos G. and Roberts, Graham and Shamji, Mohamed H. and Zieglmayer, Petra and Gerth van Wijk, Roy and Pfaar, Oliver}},
  issn         = {{0105-4538}},
  keywords     = {{allergen immunotherapy; allergy; asthma; clinical outcomes; subcutaneous; sublingual}},
  language     = {{eng}},
  number       = {{11}},
  pages        = {{2835--2850}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Allergy: European Journal of Allergy and Clinical Immunology}},
  title        = {{Standardization of clinical outcomes used in allergen immunotherapy in allergic asthma : An EAACI position paper}},
  url          = {{http://dx.doi.org/10.1111/all.15817}},
  doi          = {{10.1111/all.15817}},
  volume       = {{78}},
  year         = {{2023}},
}