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

被引:239
作者
Fleischer, David M. [1 ]
Burks, A. Wesley [2 ]
Vickery, Brian P. [2 ]
Scurlock, Amy M. [3 ,4 ]
Wood, Robert A. [5 ]
Jones, Stacie M. [3 ,4 ]
Sicherer, Scott H. [6 ]
Liu, Andrew H. [1 ]
Stablein, Donald [7 ]
Henning, Alice K. [7 ]
Mayer, Lloyd [6 ]
Lindblad, Robert [7 ]
Plaut, Marshall [8 ]
Sampson, Hugh A. [6 ]
机构
[1] Natl Jewish Hlth, Dept Pediat, Denver, CO 80206 USA
[2] Univ N Carolina, Dept Pediat, Chapel Hill, NC USA
[3] Univ Arkansas Med Sci, Dept Pediat, Little Rock, AR 72205 USA
[4] Arkansas Childrens Hosp, Little Rock, AR 72202 USA
[5] Johns Hopkins Univ, Sch Med, Dept Pediat, Baltimore, MD 21205 USA
[6] Mt Sinai Sch Med, Dept Pediat, New York, NY USA
[7] EMMES Corp, Rockville, MD USA
[8] NIAID, NIH, Bethesda, MD 20892 USA
基金
美国国家卫生研究院;
关键词
Peanut allergy; sublingual immunotherapy; desensitization; food allergy; ORAL TOLERANCE INDUCTION; HAZELNUT FOOD ALLERGY; COW MILK ALLERGY; QUALITY-OF-LIFE; NATURAL-HISTORY; ANAPHYLACTIC REACTIONS; RESOURCE IMPLICATIONS; BUDGET IMPACT; KIWI FRUIT; CHILDREN;
D O I
10.1016/j.jaci.2012.11.011
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
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. (J Allergy Clin Immunol 2013;131:119-27.)
引用
收藏
页码:119 / U184
页数:16
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