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J Allergy Clin Immunol. 2015 May;135(5):1240-8.e1-3. doi: 10.1016/j.jaci.2014.12.1917. Epub 2015 Feb 3.

Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial.

Author information

1
Department of Pediatrics, University of North Carolina, Chapel Hill, NC. Electronic address: wburks@email.unc.edu.
2
Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
3
Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
4
Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
5
Department of Pediatrics, University of Colorado Denver School of Medicine and Children's Hospital Colorado, Denver, Colo.
6
Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
7
Department of Pediatrics, National Jewish Health, Denver, Colo.
8
EMMES Corporation, Rockville, Md.
9
National Institutes of Health (National Institutes of Allergy and Infectious Diseases), Bethesda, Md.

Abstract

BACKGROUND:

We previously reported the initial results of the first multicenter, randomized, double-blind, placebo-controlled clinical trial of peanut sublingual immunotherapy (SLIT), observing a favorable safety profile associated with modest clinical and immunologic effects in the first year.

OBJECTIVE:

We sought to provide long-term (3-year) clinical and immunologic outcomes for our peanut SLIT trial. Key end points were (1) percentage of responders at 2 years (ie, could consume 5 g of peanut powder or a 10-fold increase from baseline), (2) percentage reaching desensitization at 3 years, (3) percentage attaining sustained unresponsiveness after 3 years, (4) immunologic end points, and (5) assessment of safety parameters.

METHODS:

Response to treatment was evaluated in 40 subjects aged 12 to 40 years by performing a 10-g peanut powder oral food challenge after 2 and 3 years of daily peanut SLIT therapy. At 3 years, SLIT was discontinued for 8 weeks, followed by another 10-g oral food challenge and an open feeding of peanut butter to assess sustained unresponsiveness.

RESULTS:

Approximately 98% of the 18,165 doses were tolerated without adverse reactions beyond the oropharynx, with no severe symptoms or uses of epinephrine. A high rate (>50%) discontinued therapy. By study's end, 4 (10.8%) of 37 SLIT-treated participants were fully desensitized to 10 g of peanut powder, and all 4 achieved sustained unresponsiveness. Responders at 2 years showed a significant decrease in peanut-specific basophil activation and skin prick test titration compared with nonresponders.

CONCLUSIONS:

Peanut SLIT induced a modest level of desensitization, decreased immunologic activity over 3 years in responders, and had an excellent long-term safety profile. However, most patients discontinued therapy by the end of year 3, and only 10.8% of subjects achieved sustained unresponsiveness.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00580606.

KEYWORDS:

Peanut allergy; desensitization; follow-up; food allergy; sublingual immunotherapy

PMID:
25656999
PMCID:
PMC4527157
DOI:
10.1016/j.jaci.2014.12.1917
[Indexed for MEDLINE]
Free PMC Article

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