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J Allergy Clin Immunol. 2013 Jan;131(1):119-27.e1-7. doi: 10.1016/j.jaci.2012.11.011.

Sublingual immunotherapy for peanut allergy: a randomized, double-blind, placebo-controlled multicenter trial.

Author information

1
Department of Pediatrics, National Jewish Health, Denver, CO 80206, USA. Fleischerd@njhealth.org

Abstract

BACKGROUND:

There are presently no available therapeutic options for patients with peanut allergy.

OBJECTIVE:

We sought to investigate the safety, efficacy, and immunologic effects of peanut sublingual immunotherapy (SLIT).

METHODS:

After a baseline oral food challenge (OFC) of up to 2 g of peanut powder (approximately 50% protein; median successfully consumed dose [SCD], 46 mg), 40 subjects, aged 12 to 37 years (median, 15 years), were randomized 1:1 across 5 sites to daily peanut or placebo SLIT. A 5-g OFC was performed after 44 weeks, followed by unblinding; placebo-treated subjects then crossed over to higher dose peanut SLIT, followed by a subsequent crossover Week 44 5-g OFC. Week 44 OFCs from both groups were compared with baseline OFCs; subjects successfully consuming 5 g or at least 10-fold more peanut powder than the baseline OFC threshold were considered responders.

RESULTS:

After 44 weeks of SLIT, 14 (70%) of 20 subjects receiving peanut SLIT were responders compared with 3 (15%) of 20 subjects receiving placebo (P < .001). In peanut SLIT responders, median SCD increased from 3.5 to 496 mg. After 68 weeks of SLIT, median SCD significantly increased to 996 mg (compared with Week 44, P = .05). The median SCD at the Week 44 Crossover OFC was significantly higher than baseline (603 vs 71 mg, P = .02). Seven (44%) of 16 crossover subjects were responders; median SCD increased from 21 to 496 mg among responders. Of 10,855 peanut doses through the Week 44 OFCs, 63.1% were symptom free; excluding oral-pharyngeal symptoms, 95.2% were symptom free.

CONCLUSIONS:

Peanut SLIT safely induced a modest level of desensitization in a majority of subjects compared with placebo. Longer duration of therapy showed statistically significant increases in the SCD.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00580606.

PMID:
23265698
PMCID:
PMC3550002
DOI:
10.1016/j.jaci.2012.11.011
[Indexed for MEDLINE]
Free PMC Article

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