Interaction Between Baseline Participant Factors and Treatment Effects Following Peanut Oral Immunotherapy

Melanie Lloyd; Paxton Loke; Sarah Ashley; Adriana C Lozinsky; Francesca Orsini; Michael O'Sullivan; Michael Gold; Patrick Quinn; Jessica Metcalfe; Mimi L K Tang

doi:10.1016/j.jaip.2023.12.028

Interaction Between Baseline Participant Factors and Treatment Effects Following Peanut Oral Immunotherapy

J Allergy Clin Immunol Pract. 2024 Apr;12(4):1019-1028.e2. doi: 10.1016/j.jaip.2023.12.028. Epub 2023 Dec 26.

Authors

Affiliations

¹ Allergy Immunology, Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Centre for Medicine Use and Safety, Monash University, Melbourne, Victoria, Australia.
² Allergy Immunology, Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia; Monash Children's Hospital, Melbourne, Victoria, Australia.
³ Allergy Immunology, Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Melbourne, Victoria, Australia.
⁴ Allergy Immunology, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
⁵ Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia; Clinical Epidemiology and Biostatistics, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
⁶ Department of Immunology, Perth Children's Hospital, Nedlands, Western Australia, Australia; Telethon Kid Institute, University of Western Australia, Perth, Western Australia, Australia.
⁷ Department of Paediatrics, Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia; Department of Allergy and Clinical Immunology, Women's and Children's Health Network, North Adelaide, South Australia, Australia.
⁸ Department of Allergy and Clinical Immunology, Women's and Children's Health Network, North Adelaide, South Australia, Australia.
⁹ Allergy Immunology, Murdoch Children's Research Institute, Melbourne, Victoria, Australia; Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Melbourne, Victoria, Australia. Electronic address: mimi.tang@mcri.edu.au.

PMID: 38154554
DOI: 10.1016/j.jaip.2023.12.028

Abstract

Background: The Probiotic Peanut Oral Immunotherapy-003 multicenter randomized trial found that both probiotic peanut oral immunotherapy (PPOIT) and peanut OIT alone (OIT) were effective compared with placebo in inducing clinical remission after 18 months of treatment, and improving health-related quality of life (HRQL) at 12 months after treatment. Understanding treatment effect modifiers can optimize outcomes through precision care.

Objectives: This post hoc study examined baseline clinical and demographic participant factors that modified treatment effects.

Methods: The study sample included 201 children (aged 1-10 years) with challenge-confirmed peanut allergy. Exposure variables were baseline clinical and demographic factors. Outcomes were remission (double-blind, placebo-controlled food challenge, cumulative 4,950-mg peanut protein at 8 weeks after treatment) and HRQL (change in Food Allergy Quality of Life Questionnaire-Parent Form score). Interactions between baseline factors and treatment effects on remission and HRQL were explored with regression models.

Results: A higher degree of peanut sensitivity (large peanut skin prick test, high peanut specific IgE, and low reaction-eliciting dose at study entry challenge) and other concurrent allergic conditions (multiple food allergies, asthma, or wheeze) were associated with the decreased likelihood of attaining remission after both PPOIT and OIT treatment. History of anaphylaxis was associated with the reduced likelihood of remission after PPOIT compared with OIT. For the HRQL outcome, there was evidence that sex, history of anaphylaxis, and age modified treatment effects.

Conclusions: Baseline participant factors modify PPOIT and OIT effects on remission and HRQL. Considering modifiers of treatment effect during participant selection may optimize treatment success and clinical trial design toward specific outcomes, such as the achievement of remission.

Keywords: Oral immunotherapy; Peanut allergy; Quality of life; Remission; Sustained unresponsiveness.

Publication types

Randomized Controlled Trial
Multicenter Study

MeSH terms

Administration, Oral
Allergens
Anaphylaxis*
Arachis
Child
Desensitization, Immunologic
Humans
Peanut Hypersensitivity* / therapy
Quality of Life

Substances

Allergens