A randomized controlled study of peanut oral immunotherapy: Clinical desensitization and modulation of the allergic response

作者：Varshney Pooja; Jones Stacie M; Scurlock Amy M; Perry Tamara T; Kemper Alex; Steele Pamela; Hiegel Anne; Kamilaris Janet; Carlisle Suzanne; Yue Xiaohong; Kulis Mike; Pons Laurent; Vickery Brian; Burks A Wesley^*

来源：Journal of Allergy and Clinical Immunology, 2011, 127(3): 654-660.

DOI：10.1016/j.jaci.2010.12.1111

• Peanut allergy
• oral immunotherapy
• desensitization
• food allergy

Background: Open-label oral immunotherapy (OIT) protocols have been used to treat small numbers of patients with peanut allergy. Peanut OIT has not been evaluated in double-blind, placebo-controlled trials.
Objective: To investigate the safety and effectiveness of OIT for peanut allergy in a double-blind, placebo-controlled study.
Methods: In this multicenter study, children ages 1 to 16 years with peanut allergy received OIT with peanut flour or placebo. Initial escalation, build-up, and maintenance phases were followed by an oral food challenge (OFC) at approximately 1 year. Titrated skin prick tests (SPTs) and laboratory studies were performed at regular intervals.
Results: Twenty-eight subjects were enrolled in the study. Three peanut OIT subjects withdrew early in the study because of allergic side effects. During the double-blind, placebo-controlled food challenge, all remaining peanut OIT subjects (n = 16) ingested the maximum cumulative dose of 5000 mg (approximately 20 peanuts), whereas placebo subjects (n = 9) ingested a median cumulative dose of 280 mg (range, 0-1900 mg; P < .001). In contrast with the placebo group, the peanut OIT group showed reductions in SPT size (P < .001), IL-5 (P = .01), and IL-13 (P = .02) and increases in peanut-specific IgG(4) (P < .001). Peanut OIT subjects had initial increases in peanut-specific IgE (P < .01) but did not show significant change from baseline by the time of OFC. The ratio of forkhead box protein 3 (FoxP3)(hi) : FoxP3(intermediate) CD4+ CD25+ T cells increased at the time of OFC (P = .04) in peanut OIT subjects.
Conclusion: These results conclusively demonstrate that peanut OIT induces desensitization and concurrent immune modulation. The current study continues and is evaluating the hypothesis that peanut OIT causes long-term immune tolerance. (J Allergy Clin Immunol 2011;127:654-60.)

• 出版日期2011-3