A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response.
Abstract
BACKGROUND:
Open-label oral immunotherapy (OIT) protocols have been used to treat small numbers of patients with peanut allergy. Peanut OIT has not been evaluated in double-blind, placebo-controlled trials.
OBJECTIVE:
To investigate the safety and effectiveness of OIT for peanut allergy in a double-blind, placebo-controlled study.
METHODS:
In this multicenter study, children ages 1 to 16 years with peanut allergy received OIT with peanut flour or placebo. Initial escalation, build-up, and maintenance phases were followed by an oral food challenge (OFC) at approximately 1 year. Titrated skin prick tests (SPTs) and laboratory studies were performed at regular intervals.
RESULTS:
Twenty-eight subjects were enrolled in the study. Three peanut OIT subjects withdrew early in the study because of allergic side effects. During the double-blind, placebo-controlled food challenge, all remaining peanut OIT subjects (n = 16) ingested the maximum cumulative dose of 5000 mg (approximately 20 peanuts), whereas placebo subjects (n = 9) ingested a median cumulative dose of 280 mg (range, 0-1900 mg; P < .001). In contrast with the placebo group, the peanut OIT group showed reductions in SPT size (P < .001), IL-5 (P = .01), and IL-13 (P = .02) and increases in peanut-specific IgG(4) (P < .001). Peanut OIT subjects had initial increases in peanut-specific IgE (P < .01) but did not show significant change from baseline by the time of OFC. The ratio of forkhead box protein 3 (FoxP3)(hi): FoxP3(intermediate) CD4+ CD25+ T cells increased at the time of OFC (P = .04) in peanut OIT subjects.
CONCLUSION:
These results conclusively demonstrate that peanut OIT induces desensitization and concurrent immune modulation. The current study continues and is evaluating the hypothesis that peanut OIT causes long-term immune tolerance.
Copyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
LINK TO STUDY: A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response. Journal of Allergy & Clinical Immunology. 127(3):654-60, 2011 Mar http://www.ncbi.nlm.nih.gov/pubmed/21377034
NOTE:
This is the 2nd of 3 publications on this study. While not published until 2011, this study began enrolling and treating patients in March 2007 through December 2008
See the 2009 Study report:
https://oit101.org/research/clinical-efficacy-and-immune-regulation-with-peanut-oral-immunotherapy-2009/
See the 2014 study completed after this one:
https://oit101.org/research/sustained-unresponsiveness-to-peanut-in-subjects-who-have-completed-peanut-oral-immunotherapy-2014/