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

Open access
Fleischer, David M., Burks, A. Wesley, Vickery, Brian P., Scurlock, Amy M., Wood, Robert A., Jones, Stacie M., Sicherer, Scott H., Liu, Andrew H., Stablein, Donald, Henning, Alice K., Mayer, Lloyd, Lindblad, Robert, Plaut, Marshall, Sampson, Hugh A.·2013·Journal of Allergy and Clinical Immunology

Abstract

Background There are presently no available therapeutic options for peanut-allergic patients. Objective To investigate the safety, efficacy, and immunologic effects of peanut sublingual immunotherapy (SLIT). Methods After a baseline oral food challenge (OFC) of up to 2g of peanut powder (~50% protein) (median successfully consumed dose [SCD] 46mg), 40 subjects, aged 12–37 (median 15) years, were randomized 1:1 across 5 sites to daily peanut or placebo SLIT. A 5g OFC was performed after 44 weeks followed by unblinding; placebo subjects then crossed over to higher dose peanut SLIT, followed by a subsequent crossover Week 44 5g OFC. Week 44 OFCs from both groups were compared to baseline OFCs; subjects successfully consuming 5g or at least 10-fold more peanut powder than the baseline OFC threshold were considered responders. Results After 44 weeks of SLIT, 14/20 (70%) subjects receiving peanut SLIT were responders compared to 3/20 (15%) subjects receiving placebo (p<0.001). In peanut-SLIT responders, median SCD increased from 3.5mg to 496mg. After 68 weeks of SLIT, median SCD significantly increased to 996mg (compared to week 44, p=0.05). The median SCD at the Week 44 crossover OFC was significantly higher than baseline (603mg vs 71mg; p=0.02). 7/16 (44%) crossover subjects were responders; median SCD increased from 21mg to 496mg among responders. Of 10,855 peanut doses through 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 to placebo. Longer duration of therapy showed statistically significant increases in the SCD.

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Metadata

Authors
Fleischer, D. M., Burks, A. W., Vickery, B. P., Scurlock, A. M., Wood, R. A., Jones, S. M., Sicherer, S. H., Liu, A. H., Stablein, D., Henning, A. K., Mayer, L., Lindblad, R., Plaut, M., & Sampson, H. A.
Venue
Journal of Allergy and Clinical Immunology
Publisher
Elsevier BV
Published
2013-01
Volume
131
Issue
1
Pages
119-127.e7
ISSN
0091-6749 (ISSN-L)
OpenAlex
W2097001981
Cited by
309
References
51
FWCI
21.06
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Sublingual immunotherapy for peanut allergy: A randomized, double-blind, placebo-controlled multicenter trial. https://app.cochat.ai/papers/10.1016/j.jaci.2012.11.011
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Fleischer, D. M., Burks, A. W., Vickery, B. P., Scurlock, A. M., Wood, R. A., Jones, S. M., Sicherer, S. H., Liu, A. H., Stablein, D., Henning, A. K., Mayer, L., Lindblad, R., Plaut, M., & Sampson, H. A. (2013). Sublingual immunotherapy for peanut allergy: A randomized, double-blind, placebo-controlled multicenter trial. Journal of Allergy and Clinical Immunology. https://doi.org/10.1016/j.jaci.2012.11.011

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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