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

Jasper Kappen; Zuzana Diamant; Ioana Agache; Matteo Bonini; Jean Bousquet; G. Walter Canonica; Stephen R. Durham; George V. Guibas; Eckard Hamelmann; Marek Jutel; Nikolaos G. Papadopoulos; Graham Roberts; Mohamed H. Shamji; Petra Zieglmayer; Roy Gerth van Wijk; Oliver Pfaar

doi:10.1111/all.15817

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

Jasper Kappen^*, Zuzana Diamant, Ioana Agache, Matteo Bonini, Jean Bousquet, G. Walter Canonica, Stephen R. Durham, George V. Guibas, Eckard Hamelmann, Marek Jutel, Nikolaos G. Papadopoulos, Graham Roberts, Mohamed H. Shamji, Petra Zieglmayer, Roy Gerth van Wijk, Oliver Pfaar

^*Corresponding author for this work

Internal Medicine

Research output: Contribution to journal › Article › Academic › peer-review

19 Citations (Scopus)

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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 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.

Original language	English
Pages (from-to)	2835-2850
Number of pages	16
Journal	Allergy: European Journal of Allergy and Clinical Immunology
Volume	78
Issue number	11
Early online date	14 Jul 2023
DOIs	https://doi.org/10.1111/all.15817
Publication status	Published - Nov 2023

Bibliographical note

Funding Information:
This is an EAACI TF position paper. TF meetings were financially supported by EAACI. The authors would like to thank EAACI for their financial support in the development of this Position Paper.

Publisher Copyright:
© 2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

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Cite this

Kappen, J., Diamant, Z., Agache, I., Bonini, M., Bousquet, J., Canonica, G. W., Durham, S. R., Guibas, G. V., Hamelmann, E., Jutel, M., Papadopoulos, N. G., Roberts, G., Shamji, M. H., Zieglmayer, P., Gerth van Wijk, R., & Pfaar, O. (2023). Standardization of clinical outcomes used in allergen immunotherapy in allergic asthma: An EAACI position paper. Allergy: European Journal of Allergy and Clinical Immunology, 78(11), 2835-2850. https://doi.org/10.1111/all.15817

@article{9272d68b66384c85b651cec1cce74d26,

title = "Standardization of clinical outcomes used in allergen immunotherapy in allergic asthma: An EAACI position paper",

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 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.",

author = "Jasper Kappen and Zuzana Diamant and Ioana Agache and Matteo Bonini and Jean Bousquet and Canonica, \{G. Walter\} and Durham, \{Stephen R.\} and Guibas, \{George V.\} and Eckard Hamelmann and Marek Jutel and Papadopoulos, \{Nikolaos G.\} and Graham Roberts and Shamji, \{Mohamed H.\} and Petra Zieglmayer and Roy Gerth van Wijk and Oliver Pfaar",

note = "Funding Information: This is an EAACI TF position paper. TF meetings were financially supported by EAACI. The authors would like to thank EAACI for their financial support in the development of this Position Paper. Publisher Copyright: {\textcopyright} 2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley \& Sons Ltd.",

year = "2023",

month = nov,

doi = "10.1111/all.15817",

language = "English",

volume = "78",

pages = "2835--2850",

journal = "Allergy: European Journal of Allergy and Clinical Immunology",

issn = "0105-4538",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "11",

}

Kappen, J, Diamant, Z, Agache, I, Bonini, M, Bousquet, J, Canonica, GW, Durham, SR, Guibas, GV, Hamelmann, E, Jutel, M, Papadopoulos, NG, Roberts, G, Shamji, MH, Zieglmayer, P, Gerth van Wijk, R & Pfaar, O 2023, 'Standardization of clinical outcomes used in allergen immunotherapy in allergic asthma: An EAACI position paper', Allergy: European Journal of Allergy and Clinical Immunology, vol. 78, no. 11, pp. 2835-2850. https://doi.org/10.1111/all.15817

TY - JOUR

T1 - Standardization of clinical outcomes used in allergen immunotherapy in allergic asthma

T2 - An EAACI position paper

AU - Kappen, Jasper

AU - Diamant, Zuzana

AU - Agache, Ioana

AU - Bonini, Matteo

AU - Bousquet, Jean

AU - Canonica, G. Walter

AU - Durham, Stephen R.

AU - Guibas, George V.

AU - Hamelmann, Eckard

AU - Jutel, Marek

AU - Papadopoulos, Nikolaos G.

AU - Roberts, Graham

AU - Shamji, Mohamed H.

AU - Zieglmayer, Petra

AU - Gerth van Wijk, Roy

AU - Pfaar, Oliver

N1 - Funding Information: This is an EAACI TF position paper. TF meetings were financially supported by EAACI. The authors would like to thank EAACI for their financial support in the development of this Position Paper. Publisher Copyright: © 2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

PY - 2023/11

Y1 - 2023/11

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85165266586

U2 - 10.1111/all.15817

DO - 10.1111/all.15817

M3 - Article

C2 - 37449468

AN - SCOPUS:85165266586

SN - 0105-4538

VL - 78

SP - 2835

EP - 2850

JO - Allergy: European Journal of Allergy and Clinical Immunology

JF - Allergy: European Journal of Allergy and Clinical Immunology

IS - 11

ER -

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

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