New findings show Viaskin Peanut provided significant improvements to HRQL over placebo in a pair of its clinical trials.
A new study showed a significant global and domain-specific health-related quality of life (HRQL) improvement in patients with peanut allergy treated with epicutaneous peanut immunotherapy.
The American College of Allergy, Asthma & Immunology (ACAAI) 2019 Scientific Meeting-reported findings, which compared epicutaneous immunotherapy (EPIT) candidate Viaskin Peanut from DBV Technologies to placebo, come months prior to pending US Food and Drug Administration (FDA) decision on the application of the therapy as the first regulated immunotherapy indicated for a food allergy.
The findings also complement the understood patient benefits for EPIT administration: tolerability and controlled dosing.
In an interview with MD Magazine® while at ACAAI 2019, study author Todd Green, MD, vice president of Medical Affairs for DBV Technologies, North America, described the skin patch treatment as a “simple approach” which requires no up-dosing phase, compared to oral immunotherapy.
“It’s generally a pretty convenient approach,” Green said. “There were no restrictions around activity or illness, so it seems to fit in well with the lifestyles of family—and that’s supported by high compliance rates in the high 90 percentages.”
Green and colleagues conducted a prospective HRQL-based assessment of treated and placebo patients from 12-month periods of the PEPITES and PEOPLE trials. Data used from the double-blind, randomized, controlled PEPITES study included the entire 12-month duration, and data from the open-label, follow-up PEOPLE study included the first 12 months of observation.
The team used the completed parent and children forms of the Food Allergy Quality of Life Questionnaire (FAQLQ-PF; FAQLQ-CF) from baseline, 12 months, and 24 months from the PEPITES and PEOPLE studies. They analyzed data for between-group differences only after treatment unblinding occurred.
The parent forms were assessed from 96 placebo and 209 treatment participants, respectively. The children forms were assessed from 47 placebo and 105 treatment participants, respectively.
At 24 months, both parent and children forms reported significantly lower HRQL scores among treated participants, versus placebo (LS mean 0.34, P = .008; LS mean 0.46, P = .023, respectively). Also at 24 months, parent forms among a subgroup of initially-treated patients who met the primary efficacy endpoint (LS mean 0.55, P <.001), plus any participant with an eliciting dose increase (LS mean 0.66, P <.001) were significantly improved.
At domain levels, investigators observed differences in the parent form in social dietary limitations (P = .002), food-related anxiety (P = .029), and emotional impact (P = .048) domains. Among children forms, significant changes were observed in accident exposure risk (P = .002) and allergen avoidance (P = .04) domains.
Green told MD Mag from both study data and in discussions with treated-patient families that there is interest in decreasing allergen sensitivity through increased dosing—not many are interested in achieving a level of tolerance that would allow them to potentially eat peanut.
“They just want to be reassured when they go to a party, a sleepover, or a restaurant, that they aren’t going to accidentally come across something that could trigger a reaction,” Green said. “This is all about trying to essentially have a seat belt or a safety buffer.”
These new findings, which investigators concluded indicate EPIT is associated with significant HRQL improvements versus placebo, help acknowledge that patient goal.
The study, “Improvements in Quality of Life Following Epicutaneous Peanut Immunotherapy: PEPITES and PEOPLE Studies,” was presented at ACAAI 2019.