This article is part of MPR’s coverage of the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting, being held virtually from November 13-15, 2020.
When residual peanut protein was evaluated on epicutaneous patches, it appeared that allergen delivery was achieved with at least 12 to 16 hours of daily patch application time, which should be sufficient to drive clinically meaningful desensitization to peanuts after 12 months. A post hoc analysis of data from a phase 3 clinical trial on the subject was conducted, and the results presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2020 Annual Scientific Meeting, held virtually from November 13 to 15.
Investigators sought to evaluate the association between daily application duration and efficacy of an epicutaneous patch (DBV712) containing 250 µg of peanut protein. They applied the DBV712 patch to a total of 30 nonallergic volunteers for various durations of time, ranging from 2 to 24 hours, and then examined the participants for residual peanut protein remaining on the patch. Patch application data were analyzed, based on prespecified responder rates and changes in eliciting dose with use of a geometric mean (GM) eliciting dose ratio (12 months/baseline).
Results of the study showed that median peanut protein that remained on the patch decreased from 2 to 12 hours of application and was below the limit of quantification after 12 hours. In fact, the median daily patch application duration in the phase 3 trial was 21.1 hours with DBV712 compared with 22.4 hours with placebo. Overall, 95% of the treated study population attained more than10 hours per day of mean patch application.
Of the participants with a mean range of patch application duration from more than10 hours to more than 20 hours, the prespecified responder rate ranged from 36.6% to 42.6%, with GM eliciting dose ratios of 3.8 to 4.0, respectively. Of the participants who received DBV712, those with more than 16 hours of mean application duration — which represented 84.5% of the treated population — the responder rate was 38.8%, compared with a responder rate of 13.4% with placebo (difference, 24.4%; 95% CI, 15.5%-34.0%; P <.001).
The investigators concluded that the results of this study demonstrated that since allergen delivery was attained with at least 12 to 16 hours of daily patch application, this should allow sufficient time to generate clinically meaningful desensitization to peanut after 12 months.
Spergel J, Fleischer D, Kim E, et al. Evaluation of daily patch application duration for epicutaneous immunotherapy for peanut allergy. Presented at: the American College of Allergy, Asthma & Immunology (ACAAI) 2020 Annual Scientific Meeting (Virtual Experience); November 13-15, 2020. Abstract P300.