Immunotherapy skin patch shows efficacy for toddlers with peanut allergy
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LOUISVILLE, Ky. — Epicutaneous immunotherapy conferred a significant response after 12 months among children aged 1 to 3 years with peanut allergy, according to results of the phase 3 randomized, double-blind EPITOPE study.
These results were presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting.
“There are very little published data regarding immunotherapy in infants and toddlers,” Matthew Greenhawt, MD, MBA, MSc, director of the food challenge and research unit at Children’s Hospital Colorado, told Healio. “Recently, the IMPACT study (sponsored by the Immune Tolerance Network) showed that peanut oral immunotherapy, using a 12% light-roast peanut flour, was effective in desensitizing this population.”
Given the lack of approved peanut allergy treatments for children aged younger than 4 years, Greenhawt and colleagues assessed the safety and efficacy of 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.
“You apply a patch daily to the child’s back between the shoulder blades; the first patch is applied at the study site, and subsequent applications are at home,” Greenhawt said during his presentation. “This requires no up-dosing and one of the advantages of this type of therapy is that there are no restrictions based on illness or day-to-day activities, unlike certain other therapies.”
The analysis included 362 children (median age, 2.5 years; age range, 1 to younger than 4 years; 68.8% boys) who met stopping criteria during a double-blind, placebo-controlled food challenge (DBPCFC) at an eliciting dose of 300 mg peanut protein or less. All patients also had a specific IgE of 0.7 kU/L or greater and a skin prick test of at least 6 mm.
Researchers randomly assigned the children 2:1 to receive 12 months of daily treatment with the peanut patch (n = 244) or a placebo patch (n = 118).
The percent difference in responders between the two groups, determined by comparing the eliciting dose at DBPCFC from baseline to 12 months, served as the study’s primary endpoint. The responder definition of this endpoint involved two thresholds, including 1,000 mg or greater if the baseline eliciting dose was greater than 10 mg, and 300 mg or greater if the baseline eliciting dose was 10 mg or less.
Overall, 84.8% of the children completed 12 months of treatment.
A greater proportion of the children assigned the peanut patch met the primary efficacy endpoint compared with those assigned placebo (67% vs. 33.5%; difference, 33.4%; 95% CI, 22.4%-44.5%; P < .001).
Also, 64.2% of those assigned the peanut patch compared with 29.6% of placebo patients achieved an eliciting dose of peanut protein of 1,000 mg or greater, for a difference of 34.7% (95% CI, 23.6-45.7; P < .001).
Also, a greater proportion of patients assigned the peanut patch than placebo achieved a cumulative reactive dose of 3,444 mg or greater at month 12 (37% vs. 10%; difference, 27%; 95% CI, 17.9%-36.1%; P < .001), indicating patients were able to receive all of the doses assigned at the end challenge, Greenhawt said.
When researchers evaluated reaction severity, they found that the peanut patch treatment group shifted toward less severe symptoms by month 12 (P < .001) compared with the placebo group, with a smaller proportion of the treatment group experiencing severe reactions (12.5% vs. 28.6%) and a greater proportion experiencing mild (20.5% vs. 14.3%) or no (16% vs. 5.1%) symptoms.
“These infants and toddlers who responded to treatment saw a significant increase in the amount of peanut needed to trigger a reaction, as well as a decrease in the severity of such reactions, compared with placebo-treated subjects,” Greenhawt told Healio. “These data show the incredible potential of epicutaneous therapy as well as targeting the immune response in very young children with peanut allergy.”
Researchers noted that most treatment-emergent adverse events were mild or moderate application site reactions, with serious events occurring among 8.6% of the peanut patch group vs. 2.5% of the placebo group.
Also, four patients (1.6%) assigned the peanut patch experienced treatment-related anaphylaxis, three of whom were treated with a single dose of epinephrine and one of whom discontinued treatment.
Overall, seven (2.9%) patients in the treatment group and none in the placebo group discontinued treatment due to a treatment-related adverse event.
Greenhawt described these findings as “very promising.”
“There are no FDA-approved products for treating food allergy in infants and toddlers at present, so there is an incredible need for safe and effective products for these children,” he said. “Moreover, some parents have very clearly expressed a preference for therapies that involve lower risk to the child in terms of serious adverse events, which have been associated with other therapies that require allergen ingestion to desensitize a child.”
Researchers plan to continue to follow these children to evaluate response at 3 years and to assess quality-of-life data, he added.