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.).

Food protein-induced enterocolitis syndrome: Healthcare utilization and referral patterns among a pediatric cohort.

Background: Food protein-induced enterocolitis syndrome (FPIES) is a non-IgE mediated food allergy characterized by delayed, repetitive vomiting. FPIES is improving in recognition; however, there remains a lag in diagnosis. This study aimed to further explore this lag, as well as referral patterns and healthcare utilization, to help determine areas for earlier recognition. Methods: A retrospective chart review of pediatric FPIES patients at two hospital systems in New York was completed. Charts were reviewed for FPIES episodes and healthcare visits prior to diagnosis, and reason/source of referral to an allergist. A cohort of patients with IgE-mediated food allergy was reviewed for comparison of demographics and the time to the diagnosis. Results: In total, 110 patients with FPIES were identified. The median time to diagnosis was 3 months, vs. 2 months in IgE-mediated food allergy (p < 0.05). Most referrals were from the pediatrician (68%) or gastroenterology (28%), none were from the ED. The most common reason for referral was concern of IgE-mediated allergy (51%), followed by FPIES (35%). There was a statistically significant difference in race/ethnicity between the FPIES cohort and IgE-mediated food allergy group (p < 0.0001), with a greater proportion of Caucasian patients in FPIES vs. IgE-mediated food allergy cohort. Conclusion: This study demonstrates a lag in the diagnosis of FPIES and a lack of recognition outside of the allergy community, as only one-third of patients were considered to have FPIES prior to an allergy evaluation.

Differentiating Eosinophilic Esophagitis and Eating/Feeding Disorders.

Eosinophilic esophagitis (EoE) is an inflammatory condition of the esophagus that causes symptoms of esophageal dysmotility. Patients with feeding or eating disorders (ED) can have similar symptoms, and there is a paucity of literature exploring these similarities. Furthermore, EoE can occur in addition to an ED, requiring clinicians to obtain a thorough history, make accurate diagnoses, and adequately treat all underlying conditions. We present 4 pediatric cases highlighting the similarities between EoE and ED symptomatology. Patients 1 to 3 were presumed to have an ED and were subsequently diagnosed with EoE. Patient 4 had a history of previously diagnosed and inadequately treated EoE, but was later found to also have a longstanding ED. The patients presented to the University of Rochester Pediatric Ambulatory Clinics in 2020. This series demonstrates that symptoms of EoE can overlap with those of an ED, such as anorexia nervosa or avoidant restrictive food intake disorder. Therefore, assessment for either EoE or an ED should include questions related to both diagnoses. Symptoms that may raise suspicion of EoE are indigestion, acute (versus chronic) weight loss, and dysphagia, including the inability to swallow pills, particularly in the presence of personal or family history of atopy. Patients with known EoE should be periodically evaluated for the presence of an ED. This case series illustrates that EoE can either present as an ED or complicate the diagnosis and/or treatment of an ED, making prompt diagnosis and treatment essential for successful management of all conditions.

Managing nut-induced anaphylaxis: challenges and solutions.

The prevalence of peanut and tree nut allergy in the USA has increased, especially in the pediatric population. Nut allergy remains the leading cause of fatal anaphylactic reactions. Management of anaphylaxis includes not only treatment of symptoms during a reaction, but strict dietary avoidance and education on potential situations, which may place the patient at high risk for accidental exposure. Cross-reactivity between various nuts along with various cross-contamination sources should be discussed with all nut-allergic individuals. Exciting research continues to emerge on other potential treatments for patients allergic to nuts, including allergen immunotherapy. Results of such interventions have been encouraging, though further studies are needed regarding safety and long-term outcomes before these can be applied to clinical practice.