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

Journal Article (Clinical Trial;Journal Article)

BACKGROUND: Oral immunotherapy (OIT) offers a promising therapeutic option for peanut allergy. Given that during OIT an allergic patient ingests an allergen that could potentially cause a serious reaction, the safety of OIT is of particular concern. OBJECTIVE: The purpose of this study was to examine safety during the initial escalation day, buildup phase, and home dosing phase in subjects enrolled in a peanut OIT study. METHODS: Skin, upper respiratory tract, chest, and abdominal symptoms were recorded with initial escalation day and buildup phase dosings. Subjects also maintained daily diaries detailing symptoms after each home dosing. A statistical analysis of these data was performed. RESULTS: Twenty of 28 patients completed all phases of the study. During the initial escalation day, upper respiratory tract (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 buildup phase dose was 46%, with a risk of 29% for upper respiratory tract symptoms and 24% for skin symptoms. The risk of reaction with any home dose was 3.5%. Upper respiratory tract (1.2%) and skin (1.1%) symptoms were the most likely after home doses. Treatment was given with 0.7% of home doses. Two subjects received epinephrine after 1 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.

Full Text

Duke Authors

Cited Authors

  • Hofmann, AM; Scurlock, AM; Jones, SM; Palmer, KP; Lokhnygina, Y; Steele, PH; Kamilaris, J; Burks, AW

Published Date

  • August 2009

Published In

Volume / Issue

  • 124 / 2

Start / End Page

  • 286 - 291.e6

PubMed ID

  • 19477496

Pubmed Central ID

  • PMC2731305

Electronic International Standard Serial Number (EISSN)

  • 1097-6825

Digital Object Identifier (DOI)

  • 10.1016/j.jaci.2009.03.045


  • eng

Conference Location

  • United States