Are Commercial Peanut Immunotherapy Products Cost-Effective? Interview with:

Dr. Marcus Shaker

Dr. Shaker

Marcus S. Shaker, MD
Associate Professor of Pediatrics
Associate Professor of Community and Family Medicine
Dartmouth-Hitchcock Medical Center What is the background for this study?

Response: There are two peanut allergy treatments that are being evaluated for potential FDA approval—an orally administered treatment and an epicutaneous (skin based) treatment.  Both have tremendous potential benefit.  The focus of our study was to explore the range of health and economic benefits in terms of establishing pathways for how each therapy could be cost effective.

We want to be clear that our purpose was not to suggest one therapy is or is not cost effective at present.  That would be a ridiculous statement to make regarding two treatments that not only lack FDA approval, but do not have established pricing.  Rather, we used preliminary inputs that are presently available to create as robust a model as we could to better determine the individual paths that would make them more or less cost-effective.

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Oral Peanut Immunotherapy Evaluated for Preschool Children 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 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 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 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 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 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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Boiled Peanut Immunotherapy For Peanut Allergy Interview with:
Dr Paul Turner FRACP PhD
MRC Clinician Scientist and Clinical Senior Lecturer, Imperial College London
Honorary Consultant in Paediatric Allergy & Immunology
Imperial College Healthcare NHS Trust
Hon Consultant, Royal Free Hospital / Royal Brompton & Harefield NHS Foundation Trust
Clinical trials specialist (Paediatrics), Public Health England
Clinical Associate Professor in Paediatrics, University of Sydney, Australia

Dr. Nandinee Patel, MD
Section of Paediatrics
Imperial College London
London, United Kingdom
MRC & Asthma UK Centre in Allergic Mechanisms of Asthma
London, United Kingdom What is the background for this study?

Response: Current desensitisation protocols for peanut allergy use defatted roasted peanut flour, which can be difficult to accurately measure in very low doses needed for desensitisation (and thus has resulted in the development of AR101 by Aimmune which is likely cost many thousands of dollars for a course of treatment).

We have previously observed that some children with food allergy to roasted peanut (such as peanut butter) are nonetheless able to tolerate boiled peanuts without reacting. We performed in vitro protein analysis studies which demonstrated that boiling peanuts resulted in around 50% of protein leaching out of the peanut into the cooking water. Furthermore, we found evidence for preferential leaching of allergen epitopes such as Ara h 2 as well aggregation of proteins resulting in a hypoallergenic peanut product.

We therefore sought to assess whether boiled peanuts could be as effective and safe to induce desensitisation.

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When Should Babies Eat Peanut-Containing Foods? 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 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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How Common Is Peanut Allergy Among US Children?

Supinda Bunyavanich, MD, MPH, MPhil Department of Pediatrics- Allergy/Immunology Department of Genetics and Genomic Sciences Icahn Institute for Genomics and Multiscale Biology Mindich Child Health and Development Institute Icahn School of Medicine at Mount Sinai New York, NY 10029 Interview with:
Supinda Bunyavanich, MD, MPH, MPhil
Department of Pediatrics- Allergy/Immunology
Department of Genetics and Genomic Sciences
Icahn Institute for Genomics and Multiscale Biology
Mindich Child Health and Development Institute
Icahn School of Medicine at Mount Sinai New York, NY 10029 USA

Medical Research: What are the main findings of the study?

Dr. Bunyavanich: What is the prevalence of peanut allergy among US children? Given that 90% of US households consume peanut butter, this is an important question. We report and compare prevalence estimates of childhood peanut allergy according to varying criteria among 7-10 year-old children participating in a US birth cohort not selected for any disease. The prevalence of peanut allergy ranged from 2.0% to 5.0%, depending on definition.

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