Improvements in Quality of Life in Children Following Epicutaneous Immunotherapy (EPIT) for Peanut Allergy in PEPITES and PEOPLE Studies

Abstract

Peanut allergy is associated with impaired food allergy quality of life (FAQL). Food allergy quality of life questionnaires (FAQLQs) are used to provide insight into the burdens associated with food allergy and may be used as an outcome measure instrument. In the current study, researchers examined FAQL changes after treatment with epicutaneous immunotherapy (EPIT) for peanut allergy.Data from children between the ages of 4 to 11 years who completed 12 months of therapy during the phase 3 Peanut EPIT Efficacy and Safety Study (PEPITES) and the first 12 months of the follow-on open-label extension study PEPITES Open-Label Extension Study (PEOPLE) were included in this study. PEPITES was a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of the epicutaneous peanut patch (DBV712 250μg) in 356 children. Enrolled patients had physician-diagnosed peanut allergy and reacted to ≤300 mg of peanut protein on entry double-blind placebo-controlled food challenge (DBPCFC). Participants were randomly assigned 2:1 to receive a DBV712 250μg epicutaneous peanut patch or placebo patch daily for 12 months. The PEOPLE study is designed to evaluate the long-term safety, tolerability, and efficacy of DBV712 250 μg for up to 5 years of treatment. A total of 298 children enrolled in the PEOPLE study.FAQL was prospectively measured at baseline, month 12 (before DBPCFC, with treatment allocation blinded), and month 24 (before DBPCFC for children initially randomly assigned to placebo, with treatment unblinded) by using the Food Allergy Quality of Life Questionnaire Parent Proxy Form (FAQLQ-PF) for children aged ≤12 years, and the Food Allergy Quality of Life Questionnaire Child Form (FAQLQ-CF) for children aged ≥8 years. FAQL assessments were assessed by analysis of covariance, according to between-group and in-group differences by longitudinal controlled repeated-measure analysis. FAQL assessments were also analyzed post hoc by linear regression analysis by using changes in mean and domain-specific FAQLQ-PF and FAQLQ-CF scores from baseline to month 24 as the dependent variable and treatment group and month 12 FAQLQ assessments as independent variables.FAQLQs were analyzed from placebo (FAQLQ-PF: 96; FAQLQ-CF: 47) and treatment participants (FAQLQ-PF: 209; FAQLQ-CF: 105). At 24 months, global FAQL scores were significantly improved in the treatment group (least squares mean [LSM]: 0.34 [P = .008] and 0.46 [P = .023]). At 24 months, there were significant FAQLQ-PF score improvements in patients initially randomly assigned to treatment who met the efficacy primary end point (n = 74; LSM: 0.55 [P < .001]) and in participants with any eliciting dose (ED) increase (n = 127; LSM, 0.66; P < .001). Improvements in FAQLQ-PF were observed in social dietary limitations, food-related anxiety, and emotional impact domains. Improvements in FAQLQ-CF were observed in risk of accidental exposure and allergen avoidance domains.EPIT was associated with significant global and domain-specific FAQL improvement, largely driven by increases in ED.These findings suggest that EPIT had a meaningful impact on the lives of patients and caregivers. Although there may be some bias toward positive survey responses from caregivers and patients who were satisfied with their outcomes, this encouraging study reveals a measurable modality for capturing outcome perceptions. Additional study of ongoing peanut EPIT is needed to better understand the clinical relationship between intermediate and long-term ED changes, efficacy, safety, and FAQL.