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

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

卷:131

Article

Fleischer, David M.¹  Burks, A. Wesley²  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, Donald⁷  Henning, Alice K.⁷  Mayer, Lloyd⁶  Lindblad, Robert⁷  Plaut, Marshall⁸  Sampson, Hugh A.⁶ 

[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

关键词: Peanut allergy;    sublingual immunotherapy;    desensitization;    food allergy;   

DOI  :  10.1016/j.jaci.2012.11.011

来源: Elsevier

【 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.)

【 授权许可】

Free