A randomized controlled study of peanut oral immunotherapy: Clinical desensitization and modulation of the allergic response
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-controll...
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| Published in | Journal of allergy and clinical immunology Vol. 127; no. 3; pp. 654 - 660 |
|---|---|
| Main Authors | , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.03.2011
Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
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| Abstract | 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. |
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| AbstractList | 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. 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 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. 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. 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.BACKGROUNDOpen-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.OBJECTIVETo 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.METHODSIn 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 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.RESULTSTwenty-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.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.CONCLUSIONThese 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. 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 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. 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. 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 sub(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)[super]hi: FoxP3[super]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.) 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 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. 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. 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 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: FoxP3intermediateCD4+ 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. |
| Author | Kulis, Mike Jones, Stacie M. Pons, Laurent Kemper, Alex Vickery, Brian Perry, Tamara T. Steele, Pamela Yue, Xiaohong Scurlock, Amy M. Hiegel, Anne Carlisle, Suzanne Kamilaris, Janet Varshney, Pooja Burks, A. Wesley |
| AuthorAffiliation | 1 Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, North Carolina 3 Division of Quantitative Sciences, Duke University Medical Center, Durham, North Carolina 2 Department of Pediatrics, Section of Allergy and Immunology, University of Arkansas for Medical Sciences, Little Rock, Arkansas |
| AuthorAffiliation_xml | – name: 2 Department of Pediatrics, Section of Allergy and Immunology, University of Arkansas for Medical Sciences, Little Rock, Arkansas – name: 3 Division of Quantitative Sciences, Duke University Medical Center, Durham, North Carolina – name: 1 Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, North Carolina |
| Author_xml | – sequence: 1 givenname: Pooja surname: Varshney fullname: Varshney, Pooja organization: Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC – sequence: 2 givenname: Stacie M. surname: Jones fullname: Jones, Stacie M. organization: Department of Pediatrics, Section of Allergy and Immunology, University of Arkansas for Medical Sciences, Little Rock, Ark – sequence: 3 givenname: Amy M. surname: Scurlock fullname: Scurlock, Amy M. organization: Department of Pediatrics, Section of Allergy and Immunology, University of Arkansas for Medical Sciences, Little Rock, Ark – sequence: 4 givenname: Tamara T. surname: Perry fullname: Perry, Tamara T. organization: Department of Pediatrics, Section of Allergy and Immunology, University of Arkansas for Medical Sciences, Little Rock, Ark – sequence: 5 givenname: Alex surname: Kemper fullname: Kemper, Alex organization: Division of Quantitative Sciences, Duke University Medical Center, Durham, NC – sequence: 6 givenname: Pamela surname: Steele fullname: Steele, Pamela organization: Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC – sequence: 7 givenname: Anne surname: Hiegel fullname: Hiegel, Anne organization: Department of Pediatrics, Section of Allergy and Immunology, University of Arkansas for Medical Sciences, Little Rock, Ark – sequence: 8 givenname: Janet surname: Kamilaris fullname: Kamilaris, Janet organization: Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC – sequence: 9 givenname: Suzanne surname: Carlisle fullname: Carlisle, Suzanne organization: Department of Pediatrics, Section of Allergy and Immunology, University of Arkansas for Medical Sciences, Little Rock, Ark – sequence: 10 givenname: Xiaohong surname: Yue fullname: Yue, Xiaohong organization: Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC – sequence: 11 givenname: Mike surname: Kulis fullname: Kulis, Mike organization: Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC – sequence: 12 givenname: Laurent surname: Pons fullname: Pons, Laurent organization: Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC – sequence: 13 givenname: Brian surname: Vickery fullname: Vickery, Brian organization: Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC – sequence: 14 givenname: A. Wesley surname: Burks fullname: Burks, A. Wesley email: wesley.burks@duke.edu organization: Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/21377034$$D View this record in MEDLINE/PubMed |
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| Copyright | 2011 American Academy of Allergy, Asthma & Immunology American Academy of Allergy, Asthma & Immunology Copyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved. Copyright Elsevier Limited Mar 2011 |
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| Keywords | Peanut allergy SPT Treg oral immunotherapy OIT FoxP3 food allergy OFC desensitization Oral food challenge Skin prick test Forkhead box protein 3 Regulatory T |
| Language | English |
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| Snippet | 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... Background Open-label oral immunotherapy (OIT) protocols have been used to treat small numbers of patients with peanut allergy. Peanut OIT has not been... BACKGROUND: Open-label oral immunotherapy (OIT) protocols have been used to treat small numbers of patients with peanut allergy. Peanut OIT has not been... Background: Open-label oral immunotherapy (OIT) protocols have been used to treat small numbers of patients with peanut allergy. Peanut OIT has not been... |
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| SubjectTerms | 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 |
| Title | A randomized controlled study of peanut oral immunotherapy: Clinical desensitization and modulation of the allergic response |
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