Oral Peanut Immunotherapy Evaluated for Preschool Children

MedicalResearch.com Interview with:

Lianne Soller, PhDAllergy Research ManagerUniversity of British ColumbiaVancouver, BC, Canada  

Dr. Soller

Lianne Soller, PhD
Allergy Research Manager
University of British Columbia
Vancouver, BC, Canada  

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In 2017, a clinical trial of 37 subjects demonstrated that preschool peanut oral immunotherapy was safe, with predominantly mild symptoms reported and only one moderate reaction requiring epinephrine. Our study aimed to examine whether these findings would be applicable in a real-world setting (i.e., outside of research).

We found that peanut oral immunotherapy is safe in the vast majority of preschoolers, with only 0.4% of patients experiencing a severe reaction, and only 12 out of ~40,000 peanut doses needed epinephrine (0.03%).  Continue reading

Viaskin Peanut May Offer First Epicutaneous Treatment for Peanut Allergy

MedicalResearch.com Interview with:

Todd Green MD Vice President, Medical Affairs North AmericaDBV TechnologiesAssociate Professor of PediatricsUniversity of Pittsburgh School of Medicine

Dr. Green

Todd Green MD 
Vice President, Medical Affairs North America
DBV Technologies
Associate Professor of Pediatrics
University of Pittsburgh School of Medicine

MedicalResearch.com: What is the background for this announcement? What is Viaskin Peanut?

Response: Peanut allergy is one of the most common food allergies and can cause severe, potentially life-threatening allergic reactions, including anaphylaxis. Unfortunately, there are no FDA-approved treatment options for peanut or other food allergies – leaving patients with avoidance and readiness to manage reactions to accidental exposures as their only option.

Viaskin Peanut uses epicutaneous immunotherapy or EPIT, a method of delivering biologically active compounds to the immune system through the skin. Patients receive about 1/1,000th of a peanut with each daily dose of peanut protein – the equivalent of one peanut every three years – which activates the immune system with very minimal exposure.

In February 2019, DBV announced that its planned resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin Peanut in the treatment of peanut-allergic children 4 to 11 years of age is anticipated in the third quarter of 2019.

DBV is working diligently on its resubmission package, bringing us one step closer to providing an FDA-approved treatment for peanut-allergic children and their families. Viaskin Peanut previously received Breakthrough and Fast Track designations for the treatment of peanut-allergic children from the FDA in 2015 and 2012, respectively. 

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Viaskin Peanut: Convenient Potential Treatment Option for Peanut Allergy

MedicalResearch.com Interview with:

Dr. Matthew GreenhawtDirector, Food Challenge and Research UnitChildren’s Hospital Colorado

Dr. Greenhawt

Dr. Matthew Greenhawt
Director, Food Challenge and Research Unit
Children’s Hospital Colorado

MedicalResearch.com: What is the background for this study?

Response: In the US, nearly one million children suffer from a peanut allergy and severe reactions to food allergens are not uncommon – yet there is significant unmet need in the food allergy immunotherapy space, as there are no currently approved treatment options. That being said, we are encouraged by the efficacy and safety data, which support Viaskin Peanut as a convenient and well-tolerated potential treatment option for the peanut allergy.

In the pivotal Phase III clinical trial (PEPITES) just published in The Journal of the American Medical Association (JAMA), Viaskin Peanut – the first epicutaneous immunotherapy (EPIT) in development that leverages the skin to activate the immune system – provided statistically significant desensitization in peanut-allergic children ages 4-11 years old. Patients who were treated with active therapy were more likely to have increased their eliciting dose to peanut (the amount of peanut protein ingested before an objective allergic reaction was seen during a double-blind, placebo-controlled food challenge) by a required amount as compared to patients treated with a placebo patch. The improvement suggests a reduced risk of allergic reaction to accidental peanut ingestion in the group treated with Viaskin Peanut, with no change seen in the placebo group.

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EMSY Gene Linked To Peanut and Other Food Allergies

MedicalResearch.com Interview with:

“Peanuts” by Daniella Segura is licensed under CC BY 2.0

Aida Eslami, Ph.D.
Postdoctoral Research Fellow
Dr. Denise Daley’s research group
Centre for Heart and Lung innovation
Providence Heart + Lung Institute
St. Paul’s Hospital
Vancouver, BC 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Peanut allergy and food allergies in general are caused by a combination of both genetic and environmental factors. Currently, the genetic basis of peanut allergy is unclear due to a lack of studies on food related allergies.

Our study was comprised of 850 individuals with peanut allergy from the Canadian Peanut Allergy Registry (CanPAR), and nearly 1,000 individuals without peanut allergy and other food allergies. We looked at over 7.5 million genetic markers through a genome-wide association study (GWAS) to identify genes potentially associated with peanut allergy and other food allergies. Our findings are based on results from the CanPAR in combination with the results from other countries: USA, Australia, Germany and the Netherlands.

We identified a gene that is associated with both peanut allergy and other food allergies. This gene is called c11orf30/EMSY and has previously been shown to be involved in other conditions such as asthma, eczema, and allergic rhinitis.

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When Should Babies Eat Peanut-Containing Foods?

MedicalResearch.com Interview with:

Anna Nowak-Wegrzyn, MD Associate Professor of Pediatrics Icahn School of Medicine at Mount Sinai Jaffe Food Allergy Institute New York, NY 10029

Dr. Anna Nowak-Wegrzyn

Anna Nowak-Wegrzyn, MD
Associate Professor of Pediatrics
Icahn School of Medicine at Mount Sinai
Jaffe Food Allergy Institute
New York, NY 10029

MedicalResearch.com: What is the background for this study?

Response: Peanut allergy can be fatal, is usually life-long and has no cure. Considering a dramatic increase in prevalence of peanut allergy over the past decades, affecting estimated 2-3% of infants and young children in the US, there is a dire need for prevention. Prior studies determined that risk of peanut allergy is highest in the infants with severe eczema, those with mutations in filaggrin gene resulting in an impaired skin barrier function and those not eating peanut but exposed to peanut in the household dust. In addition, the prevalence of peanut allergy was 10-fold higher among Jewish children in the United Kingdom compared with Israeli children of similar ancestry. In Israel, peanut-containing foods are usually introduced in the diet when infants are approximately 7 months of age and consumed in substantial amounts, whereas in the United Kingdom children do not typically consume any peanut-containing foods during their first year of life.

Based on these observations, a landmark clinical trial (Learning Early about Peanut Allergy, LEAP) has been designed to evaluate whether early introduction of peanut into the diet of infant considered at high risk for peanut allergy can reduce the risk of peanut allergy compared to avoidance of peanut. LEAP and other studies suggested that peanut allergy can be prevented by introduction of peanut-containing foods in infancy. The overall reduction in peanut allergy among the infants in the LEAP trial randomized to an early introduction group compared to those who avoided peanut until age 5 years was 81%.

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Early Introduction May Reduce Peanut and Egg, But Not Gluten, Allergies in Children

MedicalResearch.com Interview with:

Dr Robert Boyle Senior lecturer in paediatric allergy honorary consultant, Paediatric allergist Imperial College Healthcare NHS Trust

Dr. Robert Boyle

Dr Robert Boyle
Senior lecturer in paediatric allergy
honorary consultant, Paediatric allergist
Imperial College Healthcare NHS Trust

MedicalResearch.com: What is the background for this study? What are the main findings?

 
Editors’ note: Please discuss food introduction with your child’s pediatrician before embarking on any new foods.

Response: Food allergy is a common problem which may be getting more common.

We have known for over 100 years that feeding egg to animals such as guinea pigs can prevent egg allergy. However randomised trials of allergenic food introduction for preventing food allergy in human infants have not been done until the past 5 years, and have so far yielded mixed results. One trial for peanut allergy was positive, with less peanut allergy in infants who were fed the food from early in life compared with infants who avoided it for 5 years. Other trials have yielded null findings, but may have been too small to yield a conclusive result. We used a technique called meta-analysis to combine the results of all previous trials of timing of allergenic food introduction and risk of food allergy. We also evaluated other allergic and autoimmune diseases.

Our analysis yielded conclusive results for both egg and peanut – that early introduction of these foods into an infant’s diet might reduce their risk of egg and peanut allergy by around 40-70%. We were surprised to see null findings in our meta-analysis of timing of gluten or wheat introduction and risk of coeliac disease (gluten intolerance) which is a different type of allergy to egg and peanut allergy. This suggests that early introduction of allergenic foods does not reduce risk of all types of food allergy.

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Hello, Peanut! Offers Simple, Controlled Solution for Peanut Introduction to Babies

MedicalResearch.com Interview with:

Dr. David Erstein MD MPH Founder of Assured Bites

Dr. David Erstein

Dr. David Erstein MD MPH
Founder of Assured Bites
Board certified allergist

MedicalResearch: What is the background for peanut allergy? Why is introducing peanuts to infants important?

Dr. Erstein: Peanut allergy is one of the most common food allergies and is commonly associated with anaphylaxis, a sudden and potentially deadly condition. According to Food Allergy Research & Education, the number of children in the U.S. with a peanut allergy more than tripled between 1997 and 2008. For these reasons, peanut allergy is a hot topic and often studied condition.

There has been important emerging food allergy research including the highly publicized Immune Tolerance Network’s “Learning Early About Peanut” (LEAP) study published in the New England Journal of Medicine in 2015 and the newly announced LEAP-On study presented at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting this month. Contrary to previous guidelines, both LEAP studies advise parents of high risk infants that early and continued consumption of peanuts reduces the chance of peanut allergy development. An additional newly announced Enquiring About Tolerance (EAT) study from the 2016 AAAAI annual meeting reported early consumption of peanuts benefits even the general population of infants from developing peanut allergies, not just high risk infants.

MedicalResearch: Can you tell us about Hello, Peanut!™? How may it reduce peanut allergies? 

Dr. Erstein: Hello, Peanut! is the first-ever guided method for introducing peanuts to infants. It is the only product of its kind currently on the market for parents to offer a simple, controlled solution for peanut introduction to babies as young as 5 months, which, as the cutting edge medical research suggests reduces their chances of developing a peanut allergy.

The Hello, Peanut! Introduction System contains packets of peanut and sprouted oat blends designed to be mixed into pureed foods over seven days. The amount of peanut in each packet gradually increases daily. After this introductory phase, maintenance packets are recommended for use until the infant can eat peanut in spread or whole form.  Hello, Peanut! does not require a prescription or administration by a physician and can be fed to babies at home.

MedicalResearch: Is there anything else you would like to add?

Dr. Erstein: Hello, Peanut! is USDA organic, non GMO, dairy free, and all natural. It’s geared toward the general infant population who have no known peanut allergies and is not designed to treat or cure peanut allergies. Parents of high risk infants (Egg allergy, eczema, and/or family history of food allergies) need to consult with their pediatrician prior to peanut introduction. Hello, Peanut! is FDA registered as an early introduction system and is pending FDA approval for its ability to prevent peanut allergies.

To find out more and purchase Hello, Peanut!, please visit www.hello-peanut.com.

 

Note: Content is Not intended as medical advice or an endorsement. Please consult your health care provider regarding your specific medical condition and questions. 

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High Peanut Consumption Linked To Reduced Cardiovascular Disease Mortality

Xiao-ou Shu M.D., MPH, Ph.D Associate Director of Global Health Co-Leader, Cancer Epidemiology Research Program Ingram Professor of Cancer Research Professor of Medicine (Epidemiology) Cancer EpidemiologistMedicalResearch.com Interview with:
Xiao-ou Shu M.D., MPH, Ph.D
Associate Director of Global Health
Co-Leader, Cancer Epidemiology Research Program
Ingram Professor of Cancer Research
Professor of Medicine (Epidemiology)
Cancer Epidemiologist

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Shu: Nuts are rich in nutrients, such as unsaturated fatty acids, fiber, vitamins, phenolic antioxidants, arginine, and other phytochemicals. These are all known to be beneficial to cardiovascular health, probably through their anti-oxidative, anti-inflammatory, and endothelial function maintenance properties.   Previous studies, primarily conducted in white and affluent populations, have shown that nut consumption may be related to cardiovascular health. Much of the nut consumption in those populations would be tree nuts. In our study, we found that peanut consumption was associated with reduced total mortality and CVD mortality in a predominantly low-income black and white population in the US, and among Chinese men and women living in Shanghai. Because peanuts are much less expensive than tree nuts, as well as more widely available to people of all races and all socioeconomic backgrounds, increasing peanut consumption may provide a potentially cost-efficient approach to improving cardiovascular health.

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