Signalling good news for children with peanut allergies, a global phase three clinical trial found that a year-long immunotherapy through a skin patch safely desensitised toddlers with these allergies, lowering the risk of a severe allergic reaction from accidental exposure.
Results of the randomised, double-blind, placebo-controlled trial for children aged one-two, funded by DBV Technologies, were published in the New England Journal of Medicine.
“We were excited to contribute to this landmark study that carries so much promise,” said co-author Dr Melanie Makhija, principal investigator of the study at Ann & Robert H. Lurie Children’s Hospital of Chicago and an associate professor of Paediatrics at Northwestern University Feinberg School of Medicine.
“Children who originally reacted to a small fraction of a peanut were able to tolerate the equivalent of one to four peanuts after the treatment course. This means they will be well protected from accidental exposure to peanuts. Importantly, we found that the patch was safe, with very low chances of a severe allergic reaction. This is terrific news for families of kids with peanut allergies.”
Peanut allergy affects at least 2% of children in the US, Canada and other westernised countries, and commonly persists into adulthood. Life-threatening allergic reactions can be triggered by unintentional exposure to minute quantities, including through products manufactured on shared equipment as peanuts. Currently, there are no approved treatments for peanut-allergic children under four.
Since 2012, the clinical trials programme for food allergies at Lurie Children’s has enrolled patients on numerous studies of novel treatments, including the oral immunotherapy for peanuts that has been approved by the US Food and Drug Administration (FDA). Ongoing trials are available for all age groups, from infancy to young adulthood.
Study details
Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy
Matthew Greenhawt, Sayantani. Sindher, Wesley Burks, et al.
Published in the New England Journal of Medicine on 11 May 2023
Abstract
Background
No approved treatment for peanut allergy exists for children younger than four years of age, and the efficacy and safety of epicutaneous immunotherapy with a peanut patch in toddlers with peanut allergy are unknown.
Methods
We conducted this phase 3, multicentre, double-blind, randomised, placebo-controlled trial involving children one to three with peanut allergy confirmed by a double-blind, placebo-controlled food challenge. Patients who had an eliciting dose (the dose necessary to elicit an allergic reaction) of 300 mg or less of peanut protein were assigned in a 2:1 ratio to receive epicutaneous immunotherapy delivered by means of a peanut patch (intervention group) or to receive placebo administered daily for 12 months. The primary end point was a treatment response as measured by the eliciting dose of peanut protein at 12 months. Safety was assessed according to the occurrence of adverse events during the use of the peanut patch or placebo.
Results
Of the 362 patients who underwent randomisation, 84.8% completed the trial. The primary efficacy end point result was observed in 67.0% of children in the intervention group as compared with 33.5% of those in the placebo group (risk difference, 33.4 percentage points; 95% confidence interval, 22.4 to 44.5; P<0.001). Adverse events that occurred during the use of the intervention or placebo, irrespective of relatedness, were observed in 100% of the patients in the intervention group and 99.2% in the placebo group. Serious adverse events occurred in 8.6% of the patients in the intervention group and 2.5% of those in the placebo group; anaphylaxis occurred in 7.8% and 3.4%, respectively. Serious treatment-related adverse events occurred in 0.4% of patients in the intervention group and none in the placebo group. Treatment-related anaphylaxis occurred in 1.6% in the intervention group and none in the placebo group.
Conclusions
In this trial involving children 1 to 3 years of age with peanut allergy, epicutaneous immunotherapy for 12 months was superior to placebo in desensitising children to peanuts and increasing the peanut dose that triggered allergic symptoms.
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