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

• Published in: Journal of allergy and clinical immunology Vol. 127; no. 3; pp. 654 - 660
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2011; Elsevier Limited
• Subjects: Administration, Oral; Adolescent; adverse effects; Allergies; Allergy and Immunology; Arachis hypogaea; Asthma; Child; Child, Preschool; children; desensitization; Desensitization, Immunologic; Female; Food; Food allergies; food allergy; Humans; hypersensitivity; Hypersensitivity - immunology; Hypersensitivity - therapy; immunoglobulin E; immunoglobulin G; immunosuppression; Immunotherapy; Infant; interleukin-13; interleukin-5; Male; oral immunotherapy; patients; Peanut allergy; peanut flour; Peanut Hypersensitivity - immunology; Peanut Hypersensitivity - therapy; Peanuts; placebos; Proteins; Studies; T-lymphocytes; Peanut allergy; SPT; Treg; oral immunotherapy; OIT; FoxP3; food allergy; OFC; desensitization; Oral food challenge; Skin prick test; Forkhead box protein 3; Regulatory T
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2010.12.1111

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. To investigate the safety and effectiveness of OIT for peanut allergy in a double-blind, placebo-controlled study. 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. 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 IgG4 (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: FoxP3intermediate CD4+ CD25+ T cells increased at the time of OFC (P = .04) in peanut OIT subjects. 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.