Sublingual Immunotherapy for Peanut Allergy: A Randomized, Double-Blind, Placebo Controlled Multicenter Trial
01/2013
Journal Article
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.
Secondary:
J Allergy Clin Immunol
Volume:
131
Pagination:
119-127.e1-7
URL:
http://www.ncbi.nlm.nih.gov/pubmed/23265698
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
