Effect of Varying Doses of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Exposure Among Patients With Peanut Sensitivity

Sampson, Hugh A.; Shreffler, Wayne G.; Yang, William H.; Sussman, Gordon; Brown-Whitehorn, Terri F.; Nadeau, Kari; Cheema, Amarjit; Leonard, Stephanie A.; Pongracic, Jacqueline A.; Sauvage-Delebarre, Christine; Assa’ad, Amal; Blay, F. De; Bird, J. Andrew; Tilles, Stephen A.; Boralévi, F.; Bourrier, T.; Hébert, Jacques; Green, Todd D.; Wijk, Roy Gerth van; Knulst, André C.; Kanny, G.; Schneider, Lynda C.; Kowalski, Marek L.; Dupont, Christophe

doi:10.1001/jama.2017.16591

Cited by 182 publications

(193 citation statements)

References 21 publications

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“…The epicutaneous delivery of protein for immunotherapy is under investigation in patients with cow’s milk and peanut allergies [50–53, 54••]. The epicutaneous delivery system solubilizes the allergen by perspiration and disseminates it into the thickness of the stratum corneum [55].…”

Section: Potential Food Allergy Treatmentsmentioning

confidence: 99%

“…Epicutaneous delivery is non-invasive and may pose a lower risk for systemic reactions than other food allergen delivery approaches under study. Preliminary reports suggest that the epicutaneous antigen delivery for food allergy immunotherapy can lead to desensitization and appears to be more effective in children 6 to 11 years old than in older children and adults [53, 54••]. One important difference between the epicutaneous protocol and oral or sublingual approaches is that there is no dose escalation phase: the initial dose is the maintenance dose.…”

Section: Potential Food Allergy Treatmentsmentioning

confidence: 99%

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Food Allergy

Iweala

Choudhary

Commins

2018

Curr Gastroenterol Rep

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Purpose of Review The goal of this review is to present an updated summary of the natural history of major childhood and adult food allergies and report recent advances in potential treatments for food allergy. Recent Findings The most common childhood food allergies are typically outgrown by adolescence or adulthood. However, peanut/tree nut allergies appear to more commonly persist into adulthood. Adults can develop new IgE-mediated food allergies; the most common is oral allergy syndrome. There are multiple different approaches being tried as possible treatments for food allergy. Summary The prevalence of food allergy appears to be increasing but the varied approaches to treatment are being actively pursued such that an approved modality may not be too far in the future.

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Section: Potential Food Allergy Treatmentsmentioning

confidence: 99%

Section: Potential Food Allergy Treatmentsmentioning

confidence: 99%

Food Allergy

Iweala

Choudhary

Commins

2018

Curr Gastroenterol Rep

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“…These are immune-competent antigen-presenting cells that have the ability to initiate a regulatory T-cell response and communicate with regional lymph nodes. Daily application of EPIT patches containing 250 μg of peanut for 12 months in patients with peanut allergy has been shown to significantly raise the threshold dose for allergic reactions on food challenge [146,147]. The desensitization effect is not as marked as that of OIT, but the rate of adverse effects is minimal and mainly limited to local skin irritation where the EPIT patch has been applied [143].…”

Section: Food Allergen Immunotherapymentioning

confidence: 99%

Food Allergy Prevention and Treatment by Targeted Nutrition

Heine¹

2018

Ann Nutr Metab

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In view of the dramatic rise in the prevalence of food allergy globally, effective prevention strategies have become a public health priority. Several models have emerged around the etiology of food allergy, including the hygiene hypothesis, dual allergen exposure hypothesis, and vitamin D hypothesis. These form the basis for current and potential prevention strategies. Breastfeeding remains a key pillar of primary allergy prevention. Other nutritional interventions, including the use of whey-based, partially hydrolyzed formula in non-breastfed infants, also play an important role. In recent years, there has been a shift away from prolonged food allergen avoidance to the proactive allergen introduction from 4 months of age. This approach is supported by 2 pivotal randomized clinical trials showing that the early introduction of peanut and other food allergens significantly reduces the risk of food allergy. However, the implementation of this strategy at the population level still raises significant logistic problems, including patient selection and development of suitable food formats for young infants. Other prevention strategies, including vitamin D supplementation, are currently under evaluation. Maternal elimination diets during pregnancy and lactation are not recommended for allergy prevention. The treatment of food allergies has also seen major transformations. While strict allergen avoidance is still the key treatment principle, there is a greater focus on desensitization and tolerance induction by oral and epicutaneous immunotherapy. In addition, specialized hypoallergenic infant formulas for the treatment of infants with cow’s milk allergy have undergone reformulation, including the addition of lactose and probiotics in order to modulate the gut microbiome and early immune responses. Further research is needed to inform the most effective food allergy prevention strategies at the population level. In addition, the wider application of food allergen immunotherapy may provide better health outcomes and improved quality of life for families affected by food allergies.

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“…A successful phase II peanut immunotherapy study has been published by Sampson et al [36]. Using the technique of epicutaneous immunotherapy with peanut, they demonstrated in a one year study that active treatment generate a response rate to treatment of 25% (95% confidence interval [CI] 7.7-42.3%, mini-review p = 0.01) over placebo.…”

Section: The Choice Of the Primary Endpointmentioning

confidence: 99%

Positive and negative AIT trials: What makes the difference?

Wijk¹

2018

Allergo J

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Background Allergen immunotherapy has proven to be efficacious in allergic rhinitis and asthma. However, results from randomised clinical trials may vary substantially. Clinical trials may unexpectedly fail. The purpose of this review is to discuss the possible factors that may contribute to a successful or unsuccessful study. Methods Descriptive review exploring the possible causes of negative outcomes in allergen immunotherapy trials. Results A series of factors may lead to negative results. Among of these are underpowering of the study, low allergen content in tested extracts, insufficient allergen exposure during monitoring and recruitment of inappropriate patients. In addition, the choice of the primary endpoint may be critical. Discussion A clinical trial aims to evaluate the efficacy of an agent. However, studies with potential effective compounds may fail because of methodical issues. Sometimes, they are the cause of discrepancies between successful phase II and unsuccessful phase III trials. To understand more about failure of studies, investigators and editors should be encouraged to publish negative trials.

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Effect of Varying Doses of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Exposure Among Patients With Peanut Sensitivity

Abstract: clinicaltrials.gov Identifier: NCT01675882.

Cited by 182 publications

References 21 publications

Food Allergy

Food Allergy

Food Allergy Prevention and Treatment by Targeted Nutrition

Positive and negative AIT trials: What makes the difference?

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