LOUISVILLE, Kentucky — A 12-month course of epicutaneous immunotherapy with a patch that contained 250 μg of peanut protein was associated with significant desensitization to peanut protein compared with placebo in peanut-allergic children aged 1 to 3 years, according to results from the phase 3 EPITOPE study.
Study author Matthew Greenhawt, MD, professor of pediatrics-allergy/immunology at the University of Colorado School of Medicine in Aurora, Colorado, told Medscape Medical News that this was the first study to show that this desensitization could be accomplished over 1 year with the use of daily, non-oral, epicutaneous exposure of approximately 1/1000th of a single peanut kernel.
"These data show the incredible potential of epicutaneous therapy as well as targeting the immune response in very young children with peanut allergy," said Greenhawt, who presented the research findings here at the American College of Allergy, Asthma, and Immunology (ACAAI) 2022 Annual Meeting.
The study also found that treatment with epicutaneous immunotherapy was associated with low rates of treatment-related anaphylaxis and discontinuations due to treatment-emergent adverse events (TEAEs).
To date, no peanut allergy treatments have been approved by the US Food and Drug Administration for the treatment of peanut-allergic children younger than 4 years, highlighting a considerable unmet treatment need for this vulnerable population.
"Moreover, some parents have very clearly expressed a preference for therapies that involve lower risk to the child in terms of serious side effects, which have been associated with other therapies that require allergen ingestion to desensitize a child," reported Greenhawt.
During his presentation, Greenhawt said that studies have demonstrated "that early oral introduction of peanuts in children could reduce the risk of developing peanut allergies, suggesting that the immune system in this age may be particularly responsive to immunomodulation."
In the EPITOPE study, Greenhawt and colleagues investigated the safety and efficacy of EPIT (epicutaneous immunotherapy) with investigational VP250 in children younger than 4 years. According to Greenhawt, EPIT with VP250 "is a novel patch-based approach involving administration of microgram quantities of peanut allergen to intact skin to induce desensitization."
The investigational therapy involves a single patch that is applied daily to the backs of children. For the purposes of the study, the first patch was applied at the study site, and subsequent applications were performed at home. Each patch contains 250 μg of peanut protein.
The study included symptomatic peanut-allergic children (median age: 2.5 years; 68.8% boys) who met the stopping criteria during a double-blind, placebo-controlled food challenge (DBPCFC) at an eliciting dose of ≤300 mg of peanut protein.
Patients were randomly assigned to receive daily treatment with either the peanut patch (n = 244) or a placebo patch (n = 118) for 12 months.
For the primary endpoint, Greenhawt and colleagues evaluated the percent difference between active treatment and placebo with respect to response, as determined by DBPCFC eliciting dose at baseline and 12 months. The investigators also assessed safety.
Approximately 85% of patients completed their assigned treatment. Among these patients, a greater proportion of those who received the active peanut patch (67%) in comparison with the placebo patch (33.5%) met responder criteria. The difference between treatment groups was statistically significant (difference, 33.4%; P < .001).
Similarly, 64.2% of patients assigned active treatment and 29.6% of patients who received placebo achieved a peanut protein eliciting dose of ≥1000 mg (difference, 34.7%; P < .001).
The distribution of maximum symptom severity at month 12 shifted significantly toward less severe symptoms with VP250 compared with placebo (P < .001). According to Greenhawt, this shift toward a reduction in reaction severity occurred simultaneously with an increase in eliciting dose. In addition, there was a greater proportion of responders in the VP250 group than in the placebo arm.
Most TEAEs that were reported during the study were mild or moderate application site reactions. Serious adverse events were reported in 8.6% of patients assigned the peanut patch, vs 2.5% of patients in the placebo arm. Treatment-related anaphylaxis was experienced by 1.6% of patients treated with the peanut patch; however, these events were all mild to moderate in severity.
The overall rate of treatment adherence was high; only 2.9% of patients who received the active therapy discontinued treatment because of a TEAE.
"It will be interesting to see the data for the responders at 3 years to see the longer-term effects with regard to how more prolonged use of EPIT may further increase the amount of peanut that is required to trigger a reaction in these children, as well as to see the quality-of-life data, which are still being measured," Greenhawt commented.
Greenhawt added that the data from the PEPITES/PEOPLE study, which includes children between the ages of 4 and 11 years, demonstrated significant changes in quality of life with epicutaneous immunotherapy. "This will hopefully be the case in the EPITOPE study," he said.
Yesim Demirdag, MD, told Medscape that, given the lack of available treatment options other than avoidance for peanut-allergic children younger than 4 years, epicutaneous immunotherapy may help fill an unmet treatment need and that it represents a safe, effective, and "practical treatment option that reduces the risk of severe reactions after an accidental exposure."
Demirdag, who serves as director of the allergy and immunology fellowship program and is associate professor of clinical medicine at the University of California, Irvine, School of Medicine, was not involved with the EPITOPE study. He noted that there are important advantages of epicutaneous immunotherapy for the prevention of allergic reactions.
"Epicutaneous immunotherapy does not require frequent and prolonged office visits," commented Demirdag. "Therefore, it is much more practical for allergists and parents." Second, added Demirdag, epicutaneous immunotherapy appears "to be safer in terms of risk of severe allergic reaction, and theoretically risk of other complications, such as eosinophilic esophagitis."
The study was funded by DBV Technologies. Greenhawt reports receiving grant funding from DBV Technologies. Demirdag reports no relevant financial relationships.
American College of Allergy, Asthma, and Immunology (ACAAI) 2022 Annual Meeting: Abstract D019. Presented November 12, 2022.
Brandon May is a freelance medical journalist who has written more than 2100 articles for medical publications in the United States and the UK. Twitter: @brandonmilesmay
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Cite this: Epicutaneous Immunotherapy Promising in Young Peanut-Allergic Children - Medscape - Nov 15, 2022.