Evaluating asthma endpoints in allergen immunotherapy trials may improve efficacy and consistency

There is a need for consensus on asthma endpoints in allergen immunotherapy (AIT) trials for allergic asthma patients, according to a new study.

AIT is considered a beneficial add-on intervention to pharmacological treatment for certain asthma phenotypes. However, the evidence for its efficacy is based on controlled clinical trials that use standardized endpoint measures. The lack of consensus on asthma endpoints hinders the evaluation of AIT’s effectiveness.

To address this issue, a task force of the European Academy of Allergy and Clinical Immunology conducted an evaluation of various outcome measures for AIT in allergic asthma. The domains of outcome measures assessed in this position paper include exacerbation rate, lung function, withdrawal of inhaled corticosteroids (ICS), symptoms and rescue medication use, questionnaires, bronchial/nasal provocation, allergen exposure chambers, and biomarkers.

The results suggest that exacerbation rate can serve as a reliable objective primary outcome measure for AIT trials, although there is limited evidence due to varying definitions of exacerbation. The time from ICS withdrawal to the first exacerbation is considered a primary outcome measure.

Reference
Kappen J, Diamant Z, Agache I, et al. Standardization of clinical outcomes used in allergen immunotherapy in allergic asthma: An EAACI position paper. Allergy. 2023;doi: 10.1111/all.15817. Epub ahead of print. PMID: 37449468.