Standardization of clinical outcomes used in allergen immunotherapy in allergic asthma: An EAACI position paper.
Allergy
; 78(11): 2835-2850, 2023 11.
Article
en En
| MEDLINE
| ID: mdl-37449468
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Asma
/
Alérgenos
Límite:
Humans
Idioma:
En
Revista:
Allergy
Año:
2023
Tipo del documento:
Article
País de afiliación:
Países Bajos