Nearly half of children aged 4–7 years achieved clinically meaningful peanut desensitisation after 12 months of treatment.
A daily wearable patch delivering peanut protein through the skin significantly increased tolerance to peanut in children aged four to seven years, according to topline results from a phase 3 trial.
DBV Technologies reported that 46.6% of children treated with the epicutaneous immunotherapy patch known as the VIASKIN Peanut Patch, as part of the VITESSE trial, met predefined responder criteria after 12 months, compared with 14.8% of those receiving placebo.
The difference in response rates was 31.8%, with the lower bound of the 95% confidence interval at 24.5%, exceeding the prespecified efficacy threshold of 15%. The treatment effect was statistically significant (p<0.001).
Responder status was determined using double-blind, placebo-controlled food challenges measuring the eliciting dose – the amount of peanut protein that triggers an allergic reaction.
Children with a baseline eliciting dose of 30mg or less were considered responders if they tolerated at least 300mg after 12 months, while those starting at 100mg needed to tolerate at least 600mg.
The VITESSE study enrolled 654 children, exceeding its original recruitment target of 600 participants. Of these, 438 were randomised to receive the VIASKIN Peanut patch and 216 to placebo, with treatment groups balanced for age and baseline disease characteristics.
Safety outcomes were consistent with previous studies of the patch. The most common treatment-emergent adverse events were mild to moderate local skin reactions at the patch application site.
Discontinuation due to adverse events occurred in 3.2% of children in the treatment arm compared with 0.5% in the placebo arm. There were no treatment-related serious adverse events, and treatment-related anaphylaxis occurred in two children (0.5%), both of whom continued treatment.
Overall adherence to treatment was high at 96.2%, similar to compliance observed in earlier phase 3 studies of the VIASKIN Peanut programme.
Professor David Fleischer, professor of paediatrics at Children’s Hospital Colorado and global principal investigator of the VITESSE study, said the results showed clinically meaningful desensitisation and highlighted the potential of a non-invasive treatment approach for peanut allergy in young children.
“Peanut allergy places a considerable burden on children and their families that is insufficiently addressed by current treatment options or strict avoidance,” he said.
“I’m thrilled by these topline results which show a statistically significant treatment effect in children treated with the VIASKIN Peanut patch.
“The levels of desensitisation achieved in this study after one year on treatment are highly clinically meaningful and represent substantial progress towards a well-tolerated, non-invasive potential option that I believe would be welcomed into paediatric care.
“As a practicing allergist, I look forward to what that may mean for families managing peanut allergy every day and hope to be able to implement this treatment in my clinic, if approved.”
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The therapy uses epicutaneous immunotherapy, delivering small amounts of peanut protein through intact skin to gradually train the immune system to tolerate exposure while limiting systemic absorption.
Cherie Zachary, president of the American College of Allergy, Asthma and Immunology, said clinicians were closely watching the development of epicutaneous immunotherapy and its potential role in paediatric allergy care.
“I am excited to see what’s possible with this innovative treatment in four-seven-year-old patients, if approved,” she said.
“I look forward to open-label results in the future to fully understand the potential impact VIASKIN Peanut can have in this age group.”
DBV Technologies said it plans to submit a biologics licence application to the US Food and Drug Administration in the first half of this year. The VIASKIN Peanut patch previously received breakthrough therapy designation from the regulator and may qualify for priority review.
The company also plans to present the full VITESSE results at future medical congresses as well as submit them for publication in a peer-reviewed journal.
Allergy & Respiratory Republic contacted DBV Technologies for comment on whether it has plans for a TGA application in Australia but has not yet received a response.
