M Greenhawt et al. NEJM 2023; 388: 1755-1766. Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy
Editorial: A Togias. NEJM 2023; 388: 1814-1815. Good News for Toddlers with Peanut Allergy
Methods: This was a phase 3, multicenter, double-blind, randomized, placebo-controlled (EPITOPE) trial involving children 1 to 3 years of age with peanut allergy confirmed by a double-blind, placebo-controlled food challenge. Patients (n=362) were randomized a 2:1 ratio to receive epicutaneous immunotherapy delivered by means of a peanut patch (250 mcg) (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.
Key findings:
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
Treatment-related anaphylaxis occurred in 1.6% in the intervention group and none in the placebo group
Points from the editorial:
“The primary finding is that after receiving treatment with the peanut patch for a year, 67.0% of the toddlers in the intervention group could safely ingest the peanut-protein equivalent of approximately three to four peanuts or approximately one peanut, depending on how sensitive to peanut they were at baseline. In the placebo group, 33.5% of the children reached this end point…many practitioners have been using orally delivered foods for the same purpose for approximately a decade.”
“A trial of peanut oral immunotherapy that did not involve the use of the commercially available product was recently conducted among children 1 to 3 years of age (the Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children Trial [IMPACT]).5…The data suggest that oral immunotherapy may have a stronger protective effect than the effect reported in the EPITOPE trial.” Able to tolerate ingestion of 10 peanuts: “In the EPITOPE trial, 37% of the children in the intervention group and 10% of those in the placebo group had this result, as compared with 71% and 2%, respectively, in the IMPACT trial.”
” On the other hand, epicutaneous immunotherapy appears to have a better safety profile than oral immunotherapy…For example, allergic reactions that resulted in the administration of epinephrine occurred in 10% of the children in the intervention group in the EPITOPE trial and in 22% of those in the IMPACT trial. Also, eosinophilic esophagitis was seen in 3% of the children in the IMPACT trial who had received oral peanut immunotherapy.”
My take: Immunotherapy, oral or cutaneous, can result in some tolerance to peanuts in the majority of children. However, primary prevention of peanut allergy by timely introduction of peanuts in the diet could prevent the need for this intervention. Usually, introduction is at 4-6 months of age (though with specific precautions recommended in those with severe eczema and egg allergy).
