A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response
Pooja Varshney, Stacie M Jones, Amy M Scurlock, Tamara T Perry, Alex Kemper, Pamela Steele, Anne Hiegel, Janet Kamilaris, Suzanne Carlisle, Xiaohong Yue, Mike Kulis, Laurent Pons, Brian Vickery, A Wesley Burks, Pooja Varshney, Stacie M Jones, Amy M Scurlock, Tamara T Perry, Alex Kemper, Pamela Steele, Anne Hiegel, Janet Kamilaris, Suzanne Carlisle, Xiaohong Yue, Mike Kulis, Laurent Pons, Brian Vickery, A Wesley Burks
Abstract
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.
Copyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
Figures
![Figure 1. Cumulative amount of peanut protein…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3060783/bin/nihms273762f1.jpg)
![Figure 2. Titrated skin prick testing](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3060783/bin/nihms273762f2.jpg)
Figure 3. Changes in serum immunoglobulin levels…
Figure 3. Changes in serum immunoglobulin levels during treatment with peanut OIT and placebo
Figure 3. Changes in serum immunoglobulin levels…
Figure 3. Changes in serum immunoglobulin levels during treatment with peanut OIT and placebo
Figure 3. Changes in serum immunoglobulin levels…
Figure 3. Changes in serum immunoglobulin levels during treatment with peanut OIT and placebo
Figure 4. Changes in secreted cytokine responses…
Figure 4. Changes in secreted cytokine responses for subjects receiving peanut OIT and placebo
Figure 4. Changes in secreted cytokine responses…
Figure 4. Changes in secreted cytokine responses for subjects receiving peanut OIT and placebo
Figure 5. Change in FoxP3 hi :…
Figure 5. Change in FoxP3 hi : FoxP3 intermediate CD4+CD25+ T cells from baseline to…
Figure 5. Change in FoxP3 hi :…
Figure 5. Change in FoxP3 hi : FoxP3 intermediate CD4+CD25+ T cells from baseline to…
![Figure 3. Changes in serum immunoglobulin levels…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3060783/bin/nihms273762f3a.jpg)
![Figure 3. Changes in serum immunoglobulin levels…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3060783/bin/nihms273762f3b.jpg)
![Figure 3. Changes in serum immunoglobulin levels…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3060783/bin/nihms273762f3c.jpg)
![Figure 4. Changes in secreted cytokine responses…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3060783/bin/nihms273762f4a.jpg)
![Figure 4. Changes in secreted cytokine responses…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3060783/bin/nihms273762f4b.jpg)
![Figure 5. Change in FoxP3 hi :…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3060783/bin/nihms273762f5a.jpg)
![Figure 5. Change in FoxP3 hi :…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3060783/bin/nihms273762f5b.jpg)
Source: PubMed