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

Research output: Journal article (peer-reviewed)Journal article

3 Citations (Scopus)

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 languageEnglish
Pages (from-to)2835-2850
Number of pages16
JournalAllergy: European Journal of Allergy and Clinical Immunology
Volume78
Issue number11
Early online date14 Jul 2023
DOIs
Publication statusPublished - Nov 2023

Keywords

  • Allergens
  • Asthma/diagnosis
  • Biomarkers
  • Desensitization, Immunologic
  • Humans
  • Reference Standards

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