Allergies, Author Interviews, Pediatrics / 10.05.2023

MedicalResearch.com Interview with: Matthew Greenhawt, MD, MBA, MSc Professor of Pediatrics Section of Allergy and Immunology Director, Food Challenge and Research Unit Children’s Hospital Colorado University of Colorado School of Medicine Anschutz Medical Campus Aurora, CO 80045   MedicalResearch.com: What is the background for this study? Is the incidence of peanut allergy in toddlers stabilizing with the earlier introduction of peanuts? Response: There exists an urgent unmet medical need for infants and toddlers living with peanut allergy. Peanut allergy affects approximately 2% of U.S. children and has been a growing public health problem over the past 20 years. In fact, the number of kids affected by peanut allergy has tripled in that time span. Peanut allergy is not likely to be naturally outgrown, and reactions can be severe. However, there is hope. There is growing evidence that the allergic immune system is more modifiable early in life. The EPITOPE study evaluated Viaskin Peanut in children ages 1 – 3 years of age. Viaskin Peanut is an investigational epicutaneous immunotherapy (EPIT) product, which uses the skin as a route to desensitize a patient to be less reactive to peanut. This is a daily therapy, worn between the shoulders on the back, which allows for non-oral peanut desensitization, which many parents find highly appealing. (more…)
Allergies, Author Interviews / 24.02.2021

MedicalResearch.com Interview with:  Authors: Mike Kulis, Johanna Smeekens, Edwin Kim, Vladimir Zarnitsyn, Samirkumar Patel MedicalResearch.com: What is the background for this study? Response: Peanut allergy is an IgE-mediated disease affecting approximately 2% of young children in the United States. Over the past decade, various forms of immunotherapy have been investigated with the goal of repeated daily allergen exposure leading to a desensitized state. One of these therapies, oral immunotherapy, or OIT, received FDA approval for treating peanut allergy in January 2020 with Aimmune’s Palforzia drug. While OIT effectively induces desensitization in a majority of patients, there is a substantial burden related to side effects, with an ever-present risk of systemic anaphylaxis. (more…)
Allergies, Author Interviews, Immunotherapy, Pediatrics / 04.12.2020

MedicalResearch.com Interview with: Lianne Soller, PhD Allergy Research Manager BC Children’s Hospital Allergy Clinic Vancouver, BC, Canada MedicalResearch.com: What is the background for this study? Response: Peanut oral immunotherapy (also known as OIT) has been studied for many years in clinical trials and has been found to be safe and effective in preschoolers. However, we know that clinical trials do not always reflect what happens in the real world. We wanted to see study whether peanut OIT would work as well in the real world. This is a follow up of our preschool peanut OIT safety study published in April 2019 which noted only 0.4% severe reactions and 4% epinephrine use during build-up. (more…)
Allergies, Author Interviews, CMAJ, Pediatrics / 23.09.2020

MedicalResearch.com Interview with: Melanie Leung, M.D.,C.M. candidate 2021 4th-year medical student at McGill University Division of Allergy and Clinical Immunology Department of Pediatrics, Montreal Children’s Hospital McGill University Health Centre, Montreal, QC, Canada Dr. Moshe Ben-Shoshan, MD, MSc Pediatric allergist and immunologist at the MCH (Montreal Children’s Hospital) and Scientist at the Research Institute of the MUHC (McGill University Health Center)   MedicalResearch.com: What is the background for this study? Response: In Canada, up to 9% of children have at least 1 food allergy. Anaphylaxis is the most severe and potential life-threatening manifestation of food allergy. Peanuts and tree nuts are the main culprits in food-induced anaphylaxis and account for most fatal cases in North America. Public awareness about peanut and nut anaphylaxis can help to prevent and to act promptly, in the case of anaphylactic reaction. However, the best timing for public awareness campaigns remained unknown, as no previous study looked at the potential association between specific times of the year, such as public holidays, and the incidence of peanut and tree nut anaphylaxis. Our aim was to evaluate the risk of peanut and tree nut-induced anaphylaxis on Halloween, Christmas, Easter, Diwali, Chinese New Year, and Eid al-Adha. Data was collected from 1390 pediatric cases of peanut or nut-induced anaphylaxis across Canada (Newfoundland & Labrador, Quebec, Ontario, and British  Columbia), from 2011 to 2020. 62% of children were boys and the median age was 5.4 years. We compared the average daily number of cases during each holiday and compared it to the rest of the year (i.e.: non-holiday period). (more…)
Allergies, Author Interviews / 20.07.2020

MedicalResearch.com Interview with: Dr. Todd Green Vice President of Clinical Development and Medical Affairs https://www.dbv-technologies.com MedicalResearch.com: What is the background for this study? Response: The PEOPLE study is an open-label extension of the Phase III PEPITES trial designed to evaluate the long-term safety, tolerability and efficacy of Viaskin Peanut 250 μg (DBV712). Participants who completed the 12-month study period of PEPITES were eligible to enroll in PEOPLE, which evaluates the eliciting dose (ED) after three years (Month 36) of active treatment using a double-blind, placebo-controlled food challenge (DBPCFC).  (more…)
Allergies, Author Interviews, Pediatrics, Pharmaceutical Companies / 21.08.2019

MedicalResearch.com Interview with: Todd Green MD Vice President of Medical Affairs North America DBV Technologies https://www.dbv-technologies.com   Dr. Green discusses the recent announcement that DBV Technologies is submitting a BLA for Viaskin Peanut to the FDA.   MedicalResearch.com: What is the background for this announcement? How common is peanut allergy in children?  DBV Technologies is a global clinical-stage biopharmaceutical company whose mission is to improve the lives of patients with food allergies and other immunological diseases through our investigational epicutaneous immunotherapy technology platform. For more than 15 years, we’ve been striving to deliver transformative treatments for patients suffering with the burden and life-threatening risk of food allergies. On August 7, 2019 DBV announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years. This submission addressed the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December 2018, when DBV voluntarily withdrew its prior BLA submission for Viaskin Peanut. Peanut allergy is one of the most common food allergies and can cause severe, potentially fatal allergic reactions, including anaphylaxis. In the United States, nearly one million children suffer from a peanut allergy.[1] Fear of life-threatening reactions triggered by accidental peanut exposure during everyday activities may lead to significantly increased anxiety and decreased quality of life for patients and their families.[2,3,4] Currently, avoidance and readiness to manage accidental exposure reactions remain the standard of care. At DBV, we are committed to finding treatments that will help address the urgent unmet medical need of those suffering from food allergies, including peanut allergy, and our mission is to improve the lives of those patients and their families. (more…)
Allergies, Author Interviews, Immunotherapy, Pediatrics / 18.04.2019

MedicalResearch.com Interview with: 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%).  (more…)
Allergies, Author Interviews, Pediatrics / 04.03.2019

MedicalResearch.com Interview with: 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.  (more…)
Allergies, Author Interviews, Immunotherapy, JAMA, Pediatrics / 01.03.2019

MedicalResearch.com Interview with: 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. (more…)
Allergies, Author Interviews / 18.10.2017

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. (more…)
Allergies, Author Interviews, NIH, Pediatrics / 05.01.2017

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 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%. (more…)
Allergies, Author Interviews, JAMA, Pediatrics / 21.09.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Heart Disease, JAMA, Nutrition / 03.03.2015

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. (more…)