Peanut oral immunotherapy using an extensively heated and baked novel composition of peanuts.

BACKGROUND: Oral immunotherapy (OIT) is an increasingly acceptable therapeutic option for peanut-allergic (PA) children, despite significant side effects. Major peanut allergenic proteins are heat-resistant and are not rendered hypoallergenic after baking or cooking. Lyophilized peanut protein-MH (LPP-MH) is a novel composition from developing peanuts, enabling cooking-induced reduction in allergenicity. We aimed to explore the safety and efficacy of OIT, with extensively heated and baked (EHEB) LPP-MH in PA children. METHODS: In a single-arm, single-center, pilot study, PA children with a single highest tolerated dose of <100 mg peanut protein were placed on a 40-week OIT protocol with 300 mg daily of heat-treated LPP-MH. A repeat open peanut food challenge was performed after 40 weeks of treatment and at a 6-12 months of follow-up visit. RESULTS: Thirty-three children with PA were enrolled, with a mean cumulative tolerated dose (MCTD) of 71.2 mg PP (95% CI 45-100 mg). After 40 weeks, 32/33 patients were able to consume more than 300 mg of natural PP, with MCTD of 1709 mg (CI 365-3675 mg). There were no severe allergic reactions requiring epinephrine, during any of the observed LPP-MH challenges or any treatment related doses at home. After 6-12 months on daily maintenance, the MCTD was 8821 mg (95% CI 1930-13,500 mg). This enabled most children age-appropriate dietary inclusion of peanuts. CONCLUSION: An OIT protocol with heat-treated LPP-MH, a novel composition from developing peanuts, seems a potentially safe and efficacious OIT modality for PA children, enabling the introduction of dietary levels of peanut proteins in highly allergic PA children. Validation in randomized controlled studies is mandated.

Oral immunotherapy for children with a high-threshold peanut allergy.

BACKGROUND: Between 25% and 30% of children with peanut allergy (PA) have a relatively high-threshold peanut allergy (HTPA), with a single maximal tolerated dose (SMTD) higher than 100 mg of peanut protein (PP). However, this threshold may decrease with time, age, exercise, illness, sleep deprivation, and other covariates. OBJECTIVE: To explore the feasibility of a simplified oral immunotherapy (OIT) protocol in a group of children with HTPA. METHODS: Children with PA with an SMTD higher than 100 mg were placed on a 40-week OIT protocol of either 300 mg/d of PP or 100 mg/d for 20 weeks followed by 300 mg/d for 20 weeks. A repeat open peanut food challenge was performed after 40 weeks of treatment and at a 6-month follow-up visit. After the 40-week challenge, all children received a maintenance dosage of 2 gPP 3 times a week. RESULTS: A total of 28 children with HTPA were enrolled, with 56% boys, 89% younger than 6 years old, and a mean SMTD of 304 mg (95% confidence interval 229-378). All were placed on the described OIT protocol. Overall, 2 children were not compliant and 3 had allergic reactions at home on the dose previously tolerated in clinic, 23 completed the 40-week protocol, and all were able to consume 2 g of PP. The mean tolerated dosage at the 6-month follow-up was 8 g. This enabled most children age-appropriate dietary inclusion of peanut-containing products. CONCLUSION: In children with HTPA, a simple, fixed-dose OIT can be both safe and efficacious.

Diagnosis of Peanut Allergy in Preschool Children: The Impact of Skin Testing With a Novel Composition of Peanuts.

Peanut allergy is an increasing concern in younger children. Available bedside diagnostic tools, i.e., prick tests with commercial extracts or peanut-containing foods have only limited predictive values. In a cohort of preschoolers with both a history of allergic reactions and sensitization to peanut proteins, we aimed to characterize the impact of skin tests with a novel composition of peanuts LPP-MH. Almost one quarter (27/110) of preschool children, with a history of allergic reactions to peanuts and positive standard IgE-mediated tests for peanut allergy, can tolerate the reintroduction of peanut proteins into their diet after resolving their allergy and, thus, can avoid adverse health outcomes associated with the false diagnosis. In the younger age group, a quarter of peanut allergic children, display a relatively high threshold, potentially enabling an easier and safer oral immunotherapy protocol in this window of opportunity in childhood. The use of the novel diagnostic skin test, LPP-MH, significantly improves the predictive value of outpatient evaluation for the outcomes of peanut challenge as well as the expected threshold at which the PA child will react, thus, making for a better informed decision of how, when, and where to challenge.