Safety of a peanut oral immunotherapy protocol in children with peanut allergy

Abstract

Background Oral immunotherapy offers a promising therapeutic option for peanut allergy. Given that during oral immunotherapy an allergic patient ingests an allergen that could potentially cause a serious reaction, safety of oral immunotherapy is of particular concern. Objective The purpose of this study is to examine safety during the initial escalation day, build-up phase, and home dosing phase in subjects enrolled in a peanut oral immunotherapy study. Methods Skin, upper respiratory, chest and abdominal symptoms were recorded with initial escalation day and build-up phase dosings. Subjects also maintained daily diaries detailing symptoms after each home dosing. A statistical analysis of this data was performed. Results Twenty of 28 patients completed all phases of the study. During the initial escalation day, upper respiratory (79%) and abdominal (68%) symptoms were the most likely symptoms experienced. The risk of mild wheezing during the initial escalation day was 18%. The probability of having any symptoms after a build-up phase dose was 46%, with a risk of 29% for upper respiratory symptoms and 24% for skin symptoms. The risk of reaction with any home dose was 3.5%. Upper respiratory (1.2%) and skin (1.1%) were the most likely symptoms after home doses. Treatment was given with 0.7% of home doses. Two subjects received epinephrine after one home dose each. Conclusions Subjects were more likely to have significant allergic symptoms during the initial escalation day when they were in a closely monitored setting than during other phases of the study. Allergic reactions with home doses were rare.

Oral Immunotherapy for Food Allergy

“…Following 2 case reports of successful peanut OIT in 2006 [16,17], the first open-label trial of peanut OIT was published in 2009 in a prospective cohort study [18,19], which showed successful desensitization and an overall reassuring safety profile, as well as immunologic changes consistent with those seen in other forms of immunotherapy. With a maintenance dose of 1800 mg of peanut protein, 93% of the 29 patients who completed the protocol were able to tolerate an oral challenge with a cumulative dose of 3.9 g of peanut protein at 36 months [18].…”

“…Wasserman et al [62] reported that 95 reactions requiring epinephrine occurred during peanut OIT in 352 patients. It is especially concerning that most severe reactions occur unpredictably, with a dose that has previously been tolerated, and that they are often associated with cofactors such as infection, exercise, anxiety, or allergen coexposure [19,23,42,43].…”

The Safety of Peanut Oral Immunotherapy in Peanut Allergic Subjects in a Single Center Trial

“…(10)(11)(12)(13)(14) Since OIT necessitates ingesting the offending food, and ingestion of peanut allergen is responsible for more anaphylactic deaths than any other food allergen, it is easy to understand the trepidation of doctors and patients. However, peanut allergy is also a disease without an available disease-modifying treatment, and we live in a society where accidental exposures are almost unavoidable.…”

The Progress of Food Allergy Concept, Classifications and Diagnosis

“…OIT for peanut allergy has only recently been investigated, and there have been no studies for tree nut allergy. The first studies of OIT for peanut allergy were uncontrolled and performed in the United States [56][57] and Europe, [58][59] and these studies showed promising results. A systematic review of OIT for peanut allergy by Sheikhet [60] discussed findings from these studies and 3 abstract articles.…”