Re-evaluating treatment success in trials of peanut oral-immunotherapy: impact of different definitions on efficacy outcomes
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Purpose of review
Allergen immunotherapy (AIT) is increasingly popular as a treatment strategy for food allergy. Unfortunately, there is significant heterogeneity in reported outcomes, specifically in the dose-thresholds selected for evaluation and the symptoms used to define a “tolerated dose”. These considerations are often investigator-driven and do not consider patient perspectives.
Recent findings
A systematic review by the EAACI CO-FAITH taskforce recently flagged the need to better standardize and harmonize outcomes used in clinical trials of food-AIT. Using less objective symptoms to define dose-limiting symptoms can underestimate the reaction threshold determined at baseline food challenge. As a consequence, this can overestimate the efficacy of food-AIT by 15%. In this review, we perform an individual patient data (IPD) meta-analysis using data from three randomized-controlled trials and one real-world registry, to evaluate how the definition of dose “tolerance” impacts upon reported desensitization rates.
Summary
This analysis provides insight into how clinical efficacy rates for food-AIT are impacted by using different dose thresholds and definitions for when a dose might be consider tolerated. Using more patient-centric outcomes may be a more useful metric to harmonize reporting of outcomes and inform clinical practice, paving the way towards reaching a consensus on outcome reporting in trials of food-AIT.
Allergen immunotherapy (AIT) is increasingly popular as a treatment strategy for food allergy. Unfortunately, there is significant heterogeneity in reported outcomes, specifically in the dose-thresholds selected for evaluation and the symptoms used to define a “tolerated dose”. These considerations are often investigator-driven and do not consider patient perspectives.
Recent findings
A systematic review by the EAACI CO-FAITH taskforce recently flagged the need to better standardize and harmonize outcomes used in clinical trials of food-AIT. Using less objective symptoms to define dose-limiting symptoms can underestimate the reaction threshold determined at baseline food challenge. As a consequence, this can overestimate the efficacy of food-AIT by 15%. In this review, we perform an individual patient data (IPD) meta-analysis using data from three randomized-controlled trials and one real-world registry, to evaluate how the definition of dose “tolerance” impacts upon reported desensitization rates.
Summary
This analysis provides insight into how clinical efficacy rates for food-AIT are impacted by using different dose thresholds and definitions for when a dose might be consider tolerated. Using more patient-centric outcomes may be a more useful metric to harmonize reporting of outcomes and inform clinical practice, paving the way towards reaching a consensus on outcome reporting in trials of food-AIT.
Date Issued
2025-06-01
Date Acceptance
2025-04-01
Citation
Current Opinion in Allergy and Clinical Immunology, 2025, 25 (3), pp.185-193
ISSN
1473-6322
Publisher
Lippincott, Williams & Wilkins
Start Page
185
End Page
193
Journal / Book Title
Current Opinion in Allergy and Clinical Immunology
Volume
25
Issue
3
Copyright Statement
Copyright © 2025 The Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0
License URL
Identifier
10.1097/ACI.0000000000001077
Subjects
Humans
Peanut Hypersensitivity
Allergens
Treatment Outcome
Desensitization, Immunologic
Administration, Oral
Randomized Controlled Trials as Topic
Arachis
Publication Status
Published
Date Publish Online
2025-04-10