Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy
Background: No approved treatment for peanut allergy exists for children younger than 4 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, multicenter, double-blind, randomized, placebo-controlled trial involving children 1 to 3 years of age 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 randomization, 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 desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms. (Funded by DBV Technologies; EPITOPE ClinicalTrials.gov number, NCT03211247.). https://doi.org/10.1056/NEJMoa2212895
The protective effect of moderate maternal peanut consumption on peanut sensitization and allergy
Background: The Learning Early About Peanut Allergy or LEAP trial found that the early introduction of peanuts in the diet of infants at risk for peanut allergies prevents peanut allergy. The effect of maternal consumption of peanuts on subsequent peanut sensitization or peanut allergy in the LEAP trial has not been studied to date. Objective: To determine whether maternal consumption of peanut protein while breastfeeding protects against peanut-allergic outcomes in the absence of peanut consumption in infants. Methods: We performed an analysis of the data from the peanut avoidance arm of the LEAP study to discern the effects of maternal consumption of peanuts while pregnant and breastfeeding on an infant's peanut-allergic outcomes. Results: Of the 303 infants in the avoidance group, 31 mothers consumed more than 5 g of peanut per week, 69 consumed less than 5 g of peanut per week and 181 did not consume peanut while breastfeeding. Peanut sensitization (P = .03) and peanut allergy (P = .07) occurred less frequently in infants whose mothers consumed a moderate amount of peanuts while breastfeeding when compared with those who either did not consume peanuts while breastfeeding or those who consumed a large amount of peanuts when breastfeeding. Ethnicity (odds ratio [OR], 0.47; P = .046, 95% confidence interval [CI], 0.22-0.99), baseline peanut skin prick test stratum (OR, 4.87; P < .001, 95% CI, 2.13-11.12), no maternal peanut consumption while breastfeeding (OR, 3.25; P = .008, 95% CI, 1.36-7.77), and baseline SCORing Atopic Dermatitis greater than 40 (OR, 2.78; P = .007, 95% CI, 1.32-5.85) were all significant contributors to peanut sensitization or allergy at 60 months of age. Conclusion: Moderate consumption (<5 grams per week) of peanuts while breastfeeding provides a significant protective effect against peanut sensitization and a noticeable but not statistically significant protective effect against peanut allergy later on in life in high-risk infants in the context of delayed peanut introduction. https://doi.org/10.1016/j.anai.2023.04.012