Peanut patch reduces reaction severity in toddlers

LOUISVILLE, Ky. — The use of a peanut immunotherapy patch for 12 months appeared to reduce reaction severity while increasing eliciting dose among toddlers, according to results from the phase 3 EPITOPE study.

“Peanut allergy develops in infancy and accidental exposures may occur that result in severe reactions, including anaphylaxis,” Terri F. Brown-Whitehorn, MD, attending physician in the division of allergy and immunology, Center for Pediatric Eosinophilic Disorders and the Integrative Health Program at Children’s Hospital of Philadelphia, said during her poster presentation at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting. “There is currently no approved treatment for peanut allergy in children under 4 years of age. This demonstrates a strong, unmet need for an available treatment in this category of patients.

“We also know in young children that their immune system may be more malleable and particularly responsive to immunomodulation,” Brown-Whitehorn added.

The EPITOPE study evaluated epicutaneous immunotherapy for this population using a skin patch (VP250, DBV Technologies) containing 250 µg peanut protein, or the equivalent of approximately 1/1,000 of a single peanut, daily for 12 months. The primary analysis of this trial, also presented at ACAAI, showed a significantly higher desensitization rate in the treatment group vs. placebo group (67% vs. 33.5%; difference, 33.4%; 95% CI, 22.4%-44.5%; P < .001).

In the current analysis, researchers sought to evaluate the differences and changes in reaction severity during the double-blind, placebo-controlled food challenges (DBPCFC) at baseline to month 12 between the treatment and placebo groups.

Researchers assessed reaction severity using PRACTALL guidelines, for which each symptom domain was ranged from 0 (no symptoms) to 3 (severe symptoms). Signs and symptoms assessed during DBPCFC including those affecting the skin (erythematous rash, pruritus, urticaria) or eyes (conjunctivitis) as well as the upper/lower respiratory (sneezing, congestion, wheezing), gastrointestinal (diarrhea, vomiting) and cardiovascular (tachy/bradycardia, hypotension) systems.

The study included 362 children aged 1 to younger than 4 years randomly assigned 2:1 to receive the VP250 epicutaneous immunotherapy or placebo. All patients at baseline had an eliciting dose during the DBPCFC of 300 mg or less of peanut protein.

Of those patients, the current analysis included 200 of the children assigned VP250 and 98 assigned placebo who completed both baseline and 12-month DBPCFC. At baseline, patients in these two groups showed comparable reactive severity to DBPCFC, with 23% of the VP250 group and 25.5% of the placebo group having severe symptoms.

By month 12, the distribution of maximum symptom severity significantly shifted toward less severe symptoms in the treatment relative to placebo groups (P < .001). Conversely, the placebo group showed no significant change from baseline to month 12 in severity of symptoms.

Specifically, 12.5% of patients in the treatment group vs. 28.6% of those assigned placebo had severe symptoms at 12 months. Also, about twice as many patients assigned VP250 experienced mild or no symptoms compared with the placebo group (36.5% vs. 19.4%).

This shift in symptoms coincided with an increase in eliciting dose among patients assigned VP250, according to the researchers. Patients in the treatment group showed a 900 mg medium change in eliciting dose from baseline to month 12 compared with 0 mg in the placebo group.

“This pivotal phase 3 trial demonstrated that in addition to desensitizing children between 1 and 4 with peanut allergy with this patch, the reaction severity decreased as well, and patients needed a higher amount of peanut or eliciting dose, and tolerated much more peanut,” Brown-Whitehorn said. “This is truly an unmet need for our patients and for those of us who care for patients with peanut allergy.”