Published online: August 22, 2020
Peanut allergy is a common and persistent food allergy. Health-related Quality of Life (HRQL) is known to be poor in peanut-allergic children and their caregivers due to the burden of constant vigilance, including the fear of reactions due to accidental exposure. It is hoped that emerging treatment options can help improve HRQL, and this has been noted as a reason that families may seek therapy.
In the recent report published in The Journal of Allergy and Clinical Immunology: In Practice, Dr. DunnGalvin and her colleagues report on the effects of treatment with epicutaneous immunotherapy (EPIT) on the HRQL in children with peanut allergy. This study followed children aged 4-11 years, who had completed 12 months of therapy with DBV712 250 μg epicutaneous peanut patch (EPIT peanut patch) or placebo during the phase 3 PEPITES study, and the first 12 months of the follow-on open-label extension study PEOPLE (where all children received EPIT peanut patch). HRQL was measured by asking the parents to rate their impression of the child’s HRQL (using the Food Allergy Quality of Life Questionnaire [FAQLQ] parent form [PF]) and for children ≥8 years old, to self-rate their HRQL (using the FAQLQ child form [CF]). Measurements were taken at baseline, at 12 months (before the exit food challenge and study unblinding for PEPITES), and at 24 months. The groups were compared according to their randomization group in PEPITES (e.g. active patch or placebo) at all endpoints, with FAQLQ data from placebo participants (n = PF: 96; CF: 47) and active treatment group participants (n = PF: 209; CF: 105) available for analysis.
Overall, there was significant HRQL improvement noted at Month 24 among the children who had initially been treated with EPIT peanut patch during PEPITES, compared with those who had initially received placebo. Twenty-four–month total FAQLQ scores (for both FAQLQ-PF and -CF) were significantly improved in the treatment group versus placebo group (least squares mean 0.34, P=0.008 and 0.46, P=0.023, respectively). In addition, at 24 months, there was significant FAQLQ-PF score improvement in children initially randomized to EPIT peanut patch who met the PEPITES study eliciting dose primary efficacy endpoint (n=74, LS mean 0.55, P<0.001) and in those with any eliciting dose increase (vs. their baseline) over the first 12 months of treatment (n=127, LS mean 0.66, P<0.001). In addition to total scores, FAQL was also measured for specific categories, such as “food-related anxiety” and “social dietary limitations”. FAQLQ-PF improvements were observed across all measured categories and 2 of the 4 FAQLQ-CF categories (risk of accidental exposure (P=0.002) and allergen avoidance (P=0.04)). Nearly all changes were within a range that indicates clinical significance, in terms of meeting a (non-treatment context) minimal clinically important difference (MCID) of between 0.3-0.5. Interestingly, similar to what has been reported in studies of peanut oral immunotherapy versus placebo, no change in HRQL was noted in the 12-month data before unblinding.
These results suggest that EPIT peanut patch treatment was associated with significant improvement in HRQL in children with peanut allergy, and that HRQL may improve even with very small increases in a patient’s eliciting dose.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.