In this section
@article{Turner:2023:10.1016/j.jaci.2022.12.818,
author = {Turner, P and Patel, N and Blumchen, K and Berkes, S and Sampson, HA and Beyer, K},
doi = {10.1016/j.jaci.2022.12.818},
journal = {Journal of Allergy and Clinical Immunology},
pages = {145--154},
title = {Impact of using less objective symptoms to define tolerated dose during food challenges: a data-driven approach},
url = {http://dx.doi.org/10.1016/j.jaci.2022.12.818},
volume = {152},
year = {2023}
}
TY - JOUR
AB - Background:Food challenges (FCs) form the basis for assessing efficacy outcomes in interventional studies of food allergy; however, different studies have used a variety of similar but not identical criteria to define a challenge reaction, including subjective (nonobjective) symptoms occurring in a single-organ system as dose limiting.Objective:Our aim was to undertake a secondary analysis of 4 interventional studies to assess the impact of using less objective criteria to determine challenge-stop on reaction thresholds and their reproducibility.Methods:We analyzed individual participant data, including individual participant data meta-analysis, by using 3 different published challenge-stop criteria: (1) PRACTALL consesus criteria; (2) Consortium for Food Allergy Research version 3 (CoFAR v3) with at least 1 moderate- or severe-grade symptom; or (3) CoFAR v3 with at least 2 mild symptoms occurring in different organ systems. Reproducibility of challenge threshold was also assessed in participants undergoing subsequent repeat FCs.Results:Four studies, with detailed challenge data from a total of 592 participants, were included. Applying CoFAR v3 definitions for dose-limiting symptoms resulted in an underestimate of reaction thresholds compared with those in PRACTALL (P < .001) that is equivalent to almost a single dosing increment when using a semi-log dosing regimen. Reproducibility was also reduced when applying CoFAR v3 (P < .001 [n = 223]). Using the least conservative interpretation of CoFAR v3 (≥2 mild symptoms occurring in different systems) resulted in a significant overestimate of 15% when assessing oral immunotherapy efficacy. Applying a data-driven minor modification to CoFAR v3 resulted in a new set of challenge-stop criteria with validity similar to that of PRACTALL but one that is simpler to implement and in which significant gastrointestinal discomfort with observable decreased activity remains a dose-limiting symptom.Conclusion:The use of les
AU - Turner,P
AU - Patel,N
AU - Blumchen,K
AU - Berkes,S
AU - Sampson,HA
AU - Beyer,K
DO - 10.1016/j.jaci.2022.12.818
EP - 154
PY - 2023///
SN - 0091-6749
SP - 145
TI - Impact of using less objective symptoms to define tolerated dose during food challenges: a data-driven approach
T2 - Journal of Allergy and Clinical Immunology
UR - http://dx.doi.org/10.1016/j.jaci.2022.12.818
VL - 152
ER -