@article{ec00c81da0d34ae0b384f7d1f016ce50,
title = "Sublingual immunotherapy for peanut allergy: A randomized, double-blind, placebo-controlled multicenter trial",
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.",
keywords = "Peanut allergy, desensitization, food allergy, sublingual immunotherapy",
author = "Fleischer, {David M.} and Burks, {A. Wesley} and Vickery, {Brian P.} and Scurlock, {Amy M.} and Wood, {Robert A.} and Jones, {Stacie M.} and Sicherer, {Scott H.} and Liu, {Andrew H.} and Donald Stablein and Henning, {Alice K.} and Lloyd Mayer and Robert Lindblad and Marshall Plaut and Sampson, {Hugh A.}",
note = "Funding Information: Supported by National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID) grant U19AI066738 and U01AI066560 . The project was also supported by grant no. UL1 RR025780 from the National Center for Research Resources (NCRR)/National Institutes of Health (NIH) and grant nos. UL1 TR000154 from the NIH/National Center for Advancing Translational Sciences (National Jewish) and grant nos. UL1 TR000067 (Mount Sinai), UL1 TR000039 (Arkansas), UL 1 RR024128 (North Carolina), and UL1 RR 025005 (Johns Hopkins) from the NCRR . Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the NCRR or NIH. Funding Information: Disclosure of potential conflict of interest: D. M. Fleischer has received grants from the National Institutes of Health (NIH)/National Institutes of Allergy and Infectious Diseases (NIAID), has consultant arrangements with Sanofi-Aventis, is employed by National Jewish Health, and receives royalties from UpToDate. A. W. Burks has board memberships with the American Academy of Allergy, Asthma & Immunology, the NIH Hypersensitivity, Autoimmune, and Immune-mediated Diseases study section, the US Food and Drug Administration, and the Journal of Allergy and Clinical Immunology; is on advisory boards for the Food Allergy & Anaphylaxis Network, ActoGeniX, and Exploramed Development; has consultant arrangements with Merck, Novartis Pharma AG, the Dannon Company, McNeill Nutritionals, and Schering-Plough; is employed by UNC Children's Hospital and Duke University; has received grants from the NIH; has grants pending from the Department of Defense and the Wallace Research Foundation; receives payment for lectures from Myland Specialty; receives royalties from UpToDate; receives payment for development of educational presentations from Current Views; has stock/stock options with Allertein, Mastcell Pharmaceuticals, and Dow AgroSciences; and has received travel expenses from the European Academy of Allergy and Clinical Immunology. B. P. Vickery has received grants and travel support from the NIH/NIAID and has received grants from the American Lung Association, Cephalon, the Foundation of the American College of Allergy, Asthma & Immunology, and the Thrasher Research Fund. A. M. Scurlock has received grants from the NIH. R. A. Wood has consultant arrangements with the Asthma and Allergy Foundation of America, is employed by Johns Hopkins University, has provided expert testimony for the NIH, and received royalties from UpToDate. S. M. Jones has received grants from the NIH, the Food Allergy & Anaphylaxis Network, and the National Peanut Board; is on the Medical Advisory Board for the Food Allergy & Anaphylaxis Network; has received payment for lectures from Abbot Nutrition International, the Kentucky Society for Allergy, Asthma, and Immunology, the New England Allergy Society, the American College of Allergy, Asthma & Immunology, Indiana University Medical School and Riley Children's Hospital, the Spanish Society of Allergy and Clinic Immunology, and Oregon Allergy, Asthma & Immunology; and serves on the National Institute of Allergy and Infectious Disease Safety Monitoring Committee, the Arkansas Medicaid Drug Review Committee, and the NIAID Study Section. S. H. Sicherer has received grants from the NIH/NIAID and has consultant arrangements with the Food Allergy Initiative. D. Stablein has received grants from the NIH. A. K. Henning has received grants from the NIH. R. Lindblad has received grants from the NIH/NIAID. H. A. Sampson has received grants and travel support from the NIAID, has received grants from the NIH, is on the Danone Scientific Advisory Board, has consultant arrangements with Allertein Therapeutics and the Food Allergy Initiative, is employed by Mount Sinai Medical School, and has received royalties from Elsevier-Wiley and UpToDate. The rest of the authors declare that they have no relevant conflicts of interest. ",
year = "2013",
month = jan,
doi = "10.1016/j.jaci.2012.11.011",
language = "English (US)",
volume = "131",
pages = "119--127e7",
journal = "Journal of Allergy and Clinical Immunology",
issn = "0091-6749",
publisher = "Mosby Inc.",
number = "1",
}