Sex assigned at birth may modify health-related quality of life in children treated with peanut oral immunotherapy.

Abstract

Background: The high burden of peanut allergy underscores the need for treatment options that improve patient health-related quality of life (HRQL). However, the modifying effect of sex assigned at birth on treatment-related outcomes remains poorly understood. We sought to investigate whether sex modifies treatment effect on the change in overall and subdomain HRQL during the PPOIT-003 trial. Method(s): PPOIT-003 was a multicenter, randomized controlled trial in 201 children with peanut allergy (aged 1-10) allocated to combined probiotic and peanut oral immunotherapy (PPOIT), peanut oral immunotherapy alone (OIT), or placebo. Participant HRQL was measured with the Food Allergy Quality of Life-Parent Form (FAQLQ-PF) at baseline, end-of-treatment, and 12 months post-treatment. Multivariable linear regression with an interaction term was used to investigate the relationship between treatment and HRQL in males (N = 128, 63.68%) and females (N = 73, 36.32%). Result(s): Sex-modification of total FAQLQ-PF scores was present between baseline to end of 12 month follow-up (p =.008). In this time, improvement in FAQLQ-PF scores was significantly better in active compared to placebo groups for males (PPOIT vs. Placebo: -1.003 [95% CI: -1.571, -0.436]; OIT vs. Placebo: -1.250 [95% CI: -1.805, -0.695]), but not for females where improvement also occurred in the placebo group (PPOIT vs. Placebo: -0.148 [95% CI: -0.914, 0.617]; OIT vs. Placebo: 0.252 [95% CI: -0.547, 1.052]). Separate analysis of study phases revealed sex effect modification was greater during treatment than during post-treatment follow-up in domains related to food anxiety (p =.037) and emotional impact of allergy (p =.063). Conclusion(s): Sex modifies HRQL outcomes during peanut OIT. Greater understanding of the biological and psychosocial drivers of post-treatment HRQL will facilitate personalized management approaches.Copyright © 2025 The Author(s). Pediatric Allergy and Immunology published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.