Audrey DunnGalvin1, David M Fleischer2, Dianne E Campbell3, Jonathan O'B Hourihane4, Todd D Green5, Hugh A Sampson6, Matthew Greenhawt7. 1. School of Applied Psychology, University College Cork, Cork, Ireland; Paediatrics and Infectious Disease Department of Sechenov University, First Moscow State Medical University, Moscow, Russia. 2. Department of Pediatrics, Section of Allergy/Immunology, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo. 3. Children's Hospital at Westmead, Sydney, NSW, Australia; DBV Technologies, Montrouge, France. 4. Paediatrics and Child Health, University College Cork, Cork, Ireland; Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin, Ireland. 5. DBV Technologies, Montrouge, France; UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pa. 6. DBV Technologies, Montrouge, France. 7. Department of Pediatrics, Section of Allergy/Immunology, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo. Electronic address: Matthew.Greenhawt@childrenscolorado.org.
Abstract
BACKGROUND:Food allergy quality of life (FAQL) is impaired in children with peanut allergy. Food Allergy Quality of Life Questionnaires (FAQLQs) provide disease-specific insight into the burden of peanut allergy and potential FAQL changes after peanut immunotherapy. OBJECTIVE: To examine FAQL changes in children after treatment withepicutaneous immunotherapy for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg). METHODS:FAQL was prospectively measured using the FAQLQ parent proxy form (Food Allergy Quality of Life Questionnaire-Parent Proxy Form [FAQLQ-PF], for children aged ≤12 years) and child form (Food Allergy Quality of Life Questionnaire-Child Form [FAQLQ-CF], child rated if aged ≥8 years) during the 12-month double-blind, randomized, controlled Peanut EPIT Efficacy and Safety Study (PEPITES) trial and the initial 12 months of the open-label PEPITES Open Label Extension Study (PEOPLE) follow-up study. Data were analyzed for between-group differences after treatment unblinding. RESULTS: FAQLQs from placebo participants (FAQLQ-PF: 96; FAQLQ-CF: 47) and treatment group participants (FAQLQ-PF: 209; FAQLQ-CF: 105) were analyzed. Twenty-four-month global FAQL scores (FAQLQ-PF/FAQLQ-CF) were significantly improved in the treatment group versus the placebo group (least squares mean, 0.34, P = .008, and 0.46, P = .023, respectively). At 24 months, there was significant FAQLQ-PF score improvement in participants initially randomized to treatment who met the efficacy primary end point (n = 74; least squares mean, 0.55; P < .001) and in participants with any eliciting dose increase (n = 127; least squares mean, 0.66; P < .001). FAQLQ-PF improvements were observed in social dietary limitations (P = .002), food-related anxiety (P = .029), and emotional impact (P = .048) domains. FAQLQ-CF improvements were observed in risk of accidental exposure (P = .002) and allergen avoidance (P = .04) domains. Nearly all outcomes met a nontreatment context minimal clinically important difference previously cited for FAQLQ. CONCLUSIONS:Epicutaneous immunotherapy treatment was observed to be associated with significant global and domain-specific FAQL improvement (FAQLQ-PF/FAQLQ-CF), largely driven by increases in eliciting dose, in children with peanut allergy.
RCT Entities:
BACKGROUND: Food allergy quality of life (FAQL) is impaired in children with peanutallergy. Food Allergy Quality of Life Questionnaires (FAQLQs) provide disease-specific insight into the burden of peanutallergy and potential FAQL changes after peanut immunotherapy. OBJECTIVE: To examine FAQL changes in children after treatment with epicutaneous immunotherapy for peanutallergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg). METHODS: FAQL was prospectively measured using the FAQLQ parent proxy form (Food Allergy Quality of Life Questionnaire-Parent Proxy Form [FAQLQ-PF], for children aged ≤12 years) and child form (Food Allergy Quality of Life Questionnaire-Child Form [FAQLQ-CF], child rated if aged ≥8 years) during the 12-month double-blind, randomized, controlled Peanut EPIT Efficacy and Safety Study (PEPITES) trial and the initial 12 months of the open-label PEPITES Open Label Extension Study (PEOPLE) follow-up study. Data were analyzed for between-group differences after treatment unblinding. RESULTS: FAQLQs from placebo participants (FAQLQ-PF: 96; FAQLQ-CF: 47) and treatment group participants (FAQLQ-PF: 209; FAQLQ-CF: 105) were analyzed. Twenty-four-month global FAQL scores (FAQLQ-PF/FAQLQ-CF) were significantly improved in the treatment group versus the placebo group (least squares mean, 0.34, P = .008, and 0.46, P = .023, respectively). At 24 months, there was significant FAQLQ-PF score improvement in participants initially randomized to treatment who met the efficacy primary end point (n = 74; least squares mean, 0.55; P < .001) and in participants with any eliciting dose increase (n = 127; least squares mean, 0.66; P < .001). FAQLQ-PF improvements were observed in social dietary limitations (P = .002), food-related anxiety (P = .029), and emotional impact (P = .048) domains. FAQLQ-CF improvements were observed in risk of accidental exposure (P = .002) and allergen avoidance (P = .04) domains. Nearly all outcomes met a nontreatment context minimal clinically important difference previously cited for FAQLQ. CONCLUSIONS: Epicutaneous immunotherapy treatment was observed to be associated with significant global and domain-specific FAQL improvement (FAQLQ-PF/FAQLQ-CF), largely driven by increases in eliciting dose, in children with peanutallergy.
Authors: Philippe Bégin; John Andrew Bird; Jonathan M Spergel; Dianne E Campbell; Todd D Green; Katharine J Bee; Romain Lambert; Hugh A Sampson; David M Fleischer Journal: Allergy Date: 2021-09-28 Impact factor: 14.710
Authors: Gabriel Lins de Holanda Coelho; Audrey DunnGalvin; Matthew Greenhawt; Jonathan O'B Hourihane; David M Fleischer; Gang Chen; Marcus Shaker; Dianne E Campbell; Todd D Green; Philippe Bégin Journal: Allergy Date: 2022-05-02 Impact factor: 14.710