Allergies, Author Interviews, CMAJ, Pediatrics / 23.09.2020

MedicalResearch.com Interview with: [caption id="attachment_55467" align="alignleft" width="176"]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 Melanie Leung[/caption] 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).
Allergies, Author Interviews, Genetic Research, Hepatitis - Liver Disease / 08.09.2020

MedicalResearch.com Interview with: [caption id="attachment_55352" align="alignleft" width="200"]Takanori Takebe MD Director for Commercial Innovation, Center for Stem Cell and Organoid Research and Medicine (CuSTOM) Assistant Professor, University Cincinnati Department of Pediatrics, Cincinnati Children’s Professor, Institute of Research Tokyo Medical and Dental University, Japan Dr. Takebe[/caption] Takanori Takebe MD Director for Commercial Innovation, Center for Stem Cell and Organoid Research and Medicine (CuSTOM) Assistant Professor, University Cincinnati Department of Pediatrics, Cincinnati Children’s Professor, Institute of Research Tokyo Medical and Dental University, Japan  MedicalResearch.com: What is the background for this study?  What are the main findings? Response: Drug induced liver injury (DILI) is rare yet highly unpredictable disorder that oftentimes causes drug failure withdrawn from the market during clinical trial even at a very rare incidence of DILI (1/10,000). Indeed, one particular drug TAK875 (Fasigliam) was the case despite promising efficacy. This not only disappoints patient but impact significant financial risk to pharmaceuticals. In collaboration with DILI genomics consortium at US, EU and UK, we’ve found +20,000 genetic make up (variants) defines potential risk of developing Drug induced liver injury thru amplifying cellular stress signal cascades that were investigated by human cell, organoid and patient datasets.
Allergies, Author Interviews, Dermatology, Pediatrics / 25.07.2020

MedicalResearch.com Interview with: [caption id="attachment_54947" align="alignleft" width="177"]Catherine M. Ludwig Catherine M. Ludwig[/caption] Catherine M. Ludwig is a 4th year medical student at the University of Illinois Chicago College of Medicine. Her interests in dermatology include inflammatory and genetic conditions, especially within pediatric dermatology.   [caption id="attachment_54948" align="alignleft" width="163"]Alyssa M. Thompson Alyssa M. Thompson[/caption]   Alyssa M. Thompson is currently a 2nd year medical student at the UA-COM Tucson. She graduated from the University of Arizona, Summa Cum Laude in 2018 as the athletic department's Valedictorian with a degree in Physiology and an Entrepreneurship certificate. Her passion for research and dermatology stems from her innovative and integrative mindset with specific interest in inflammatory skin disease.     MedicalResearch.com: What is the background for this study? Response: Eczema is very common in children. Prescription medications are important for managing eczema flares, but a lot of the work in treating eczema is preventative, done by consistently moisturizing the skin at home with drug store products. Allergic contact dermatitis occurs more commonly in people with eczema. A previous study was done in characterizing the allergenic potential of drug-store moisturizers and found that 88% of moisturizers contain at least one common allergen. Many moisturizers are marketed specifically to eczema, but the allergen content of these products are unknown.
Allergies, Author Interviews, Pediatrics / 24.07.2020

MedicalResearch.com Interview with: [caption id="attachment_54929" align="alignleft" width="200"]Kirsten P Perrett MD PhD Group Leader/Clinician Scientist Fellow Population Allergy Research Group and Melbourne Children's Trial Centre Murdoch Children's Research Institute Dr. Perrett[/caption] Kirsten P Perrett MD PhD Group Leader/Clinician Scientist Fellow Population Allergy Research Group and Melbourne Children's Trial Centre Murdoch Children's Research Institute   Rachel L Peters PhD Murdoch Children’s Research Institute Department of Paediatrics The University of Melbourne Parkville, Australia MedicalResearch.com: What is the background for this study? cashews-wikipedia-image Response: The prevalence of food allergy has increased over the last 1-2 decades. Historically, parents were advised to withhold the introduction of allergenic foods, such as peanut or egg, until after the infant was 1-3 years of age in the hope that it would prevent food allergy. However, recent evidence has shown that introducing peanut and egg in the first year of life, reduces the risk of allergy to that food. This has led to a paradigm shift in infant feeding advice from active avoidance to timely introduction. However, there has not been any research advising on the timing of tree nuts, a common cause of food allergy, MedicalResearch.com: What are the main findings? Response: Our study of nearly 3000 children in the population-based HealthNuts study in Australia, found that only 5% had eaten cashew by age 12 months. Interestingly, no child who consumed cashew by age 12 months, developed cashew allergy at age 6 years; conversely 3.6% of those who had not consumed cashew by age 12 months did develop cashew allergy at age 6 years. Our findings suggest that introducing cashew in the first year of life may reduce the risk of cashew allergy.
Allergies, Author Interviews, Dermatology / 22.07.2020

MedicalResearch.com Interview with: [caption id="attachment_13209" align="alignleft" width="130"]Emma Guttman-Yassky, MD, PhD Department of Dermatology Icahn School of Medicine at Mount Sinai Medical Center New York, NY 10029 Dr. Guttman-Yassky[/caption] Emma Guttman-Yassky, MD, PhD Professor of Dermatology and Immunology Vice Chair of the Department of Dermatology Icahn School of Medicine MedicalResearch.com: What is the background for this study? What is the importance of differentiating these two skin conditions?   Response: The background is that up to now skin biopsies were considered the gold standard for obtaining skin biomarkers of atopic dermatitis/AD and psoriasis that are linked to disease activity in skin and for obtaining the cutaneous gene and protein expression fingerprint of each individual disease. Biopsies are also used in clinical trials to obtain the skin phenotype. However biopsies are invasive, painful and scarring. Thus we need less invasive means to profile diseases and obtain biomarkers. Tape strips is a minimally invasive approach to sample and study the skin. However, prior studies using tape strips could not fully capture the phenotype of the diseases and also sampling the recovery rate was less than optimal, not allowing this approach to be widely used. Psoriasis and AD are the most common inflammatory skin diseases, but these diseases are treated very differently and in some cases are very difficult to differentiate between them clinically and even in biopsies. 
Allergies, Author Interviews / 20.07.2020

MedicalResearch.com Interview with: [caption id="attachment_51005" align="alignleft" width="159"]Todd Green MD Vice President of Medical Affairs North America DBV Technologies Dr. Green[/caption] 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). 
Allergies, Author Interviews, JAMA, OBGYNE / 05.06.2020

MedicalResearch.com Interview with: Niklas Andersson MS Department of Epidemiology Research Statens Serum Institut Copenhagen S, Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: Second-generation antihistamines are among the most commonly prescribed drug classes during pregnancy. Fexofenadine is a widely used antihistamine but given the limited fetal safety on the use of antihistamines during pregnancy in general, current clinical guidelines only recommend the use cetirizine and loratadine during pregnancy when needed due to a larger body of fetal safety data for these antihistamines.
Allergies, Asthma, AstraZeneca, Author Interviews / 01.05.2020

MedicalResearch.com Interview with: astrazenecaOlga Ryan, DrPH, MPH, MBA Regional Clinical Account Director, Southwest AstraZeneca  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Asthma is common and imparts a substantial societal burden. It is well documented that asthma prevalence varies between males and females. Before puberty, more boys have asthma.  Following puberty, a greater proportion of women suffer with asthma. We also have observed that women experience greater morbidity from the illness, greater healthcare resource utilization and suboptimal response for guideline recommended therapies (ICS, ICS/LABA). Rationale for this study focused on describing asthma related outcomes between a well characterized severe asthma cohort, with intent in delineating differences among the sexes. With the advent of targeted biological medicines for severe asthma, as well as apparent gaps in knowledge, we wanted to understand potential sex-specific disease indicators in a well characterized severe asthma cohort.
Allergies, Asthma, Author Interviews, ENT / 23.03.2020

MedicalResearch.com Interview with: [caption id="attachment_53614" align="alignleft" width="160"]Joseph Han, MD FARS, FAAOA FAAAAI Medical Director for the Division of Allergy Eastern Virginia Medical School Dr. Han[/caption] Joseph Han, MD FARS, FAAOA FAAAAI Medical Director for the Division of Allergy Eastern Virginia Medical School  MedicalResearch.com: What is the background for this study? Response: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease of the nasal passages and sinuses associated with a high symptom burden due to the chronic, relapsing nature of the disease. If you ask CRSwNP patients about the most important disease symptoms, they would say nasal congestion and decrease in smell. However, many CRSwNP patients would say that losing their sense of smell is particularly troublesome. This study was conducted to better understand the effect of dupilumab, which is approved in the U.S. for adults with uncontrolled CRSwNP, on sense of smell.  
Allergies, Author Interviews, Dermatology / 20.03.2020

MedicalResearch.com Interview with: [caption id="attachment_53601" align="alignleft" width="144"]Gil Yosipovitch, MD, Professor Miami Itch Center Lennar Medical Foundation South Miami Clinic in Coral Gables University of Miami Health System Dr. Yosipovitch[/caption] Gil Yosipovitch, MD, Professor Miami Itch Center Lennar Medical Foundation South Miami Clinic in Coral Gables University of Miami Health System MedicalResearch.com: What is the background for this study? How does Dupilumab (Dupixent) differ from other medications for atopic dermatitis/eczema? Response: Atopic dermatitis (AD) is characterized by intense itch (pruritus) that is one of the most burdensome symptoms; therefore, rapid and sustained improvement in itch is an important marker of treatment benefit. Dupixent® (dupilumab) is approved in the U.S. for adults and adolescents with inadequately-controlled moderate-to-severe Atopic Dermatitis. Dupilumab remains the first and only biologic medicine for uncontrolled moderate-to-severe atopic dermatitis. Dupilumab is the first and only fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from dupilumab clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyps. 
Allergies, Asthma, Author Interviews, Dermatology, Pediatrics / 10.03.2020

MedicalResearch.com Interview with: [caption id="attachment_53396" align="alignleft" width="121"]Marcella Aquino, M.D. Hasbro Children's Hospital Department of Pediatrics Division of Allergy & Immunology Associate Professor of Pediatrics Dr. Aquino[/caption] Marcella Aquino, M.D. Hasbro Children's Hospital Department of Pediatrics Division of Allergy & Immunology Associate Professor of Pediatrics   [caption id="attachment_53397" align="alignleft" width="107"]Daphne Koinis-Mitchell PhD                                    Professor (Research) in the Departments of Psychiatry and                                    Human Behavior and Pediatrics Dr. Koinis-Mitchell[/caption] Daphne Koinis-Mitchell PhD Professor (Research) in the Departments of Psychiatry and Human Behavior and Pediatrics Warren Alpert Medical School of Brown University Providence, Rhode Island 02903   MedicalResearch.com: What is the background for this study? Response: Urban minority children with asthma are at increased risk for sleep loss and poorer sleep quality secondary to socio-contextual stressors (poverty, stressors of urban living) and the underlying challenges related to following possibly complex asthma treatment regimens. Atopic dermatitis (AD) is very frequently seen in children with asthma and increases the risk for poor quality sleep, for example difficulty falling asleep, awakenings during the night, difficulty awakening in the morning, and/or daytime sleepiness. 
Allergies, Author Interviews, CMAJ, Environmental Risks, Pediatrics / 20.02.2020

MedicalResearch.com Interview with: Jaclyn Parks, B.Sc. Health Sciences M.Sc. Health Sciences Candidate | Faculty of Health Sciences Simon Fraser University Burnaby, B.C MedicalResearch.com: What is the background for this study? Response: Childhood asthma is a major public health concern, and many researchers are interested in determining environmental and modifiable exposures in early life so that we can recommend preventative measures. The findings of our study add to the understanding of which exposures in early life may be important to the development of childhood asthma and allergies and allows us to identify specific areas of intervention for parents and other stakeholders involved in protecting children’s health.
Allergies, Author Interviews / 22.01.2020

MedicalResearch.com Interview with: [caption id="attachment_52925" align="alignleft" width="133"]Dr. Dianne Campbell, MBBS, FRACP, PhD VP, Global Medical Affairs DBV Technologies   Dr. Campbell[/caption] Dr. Dianne Campbell, MBBS, FRACP, PhD VP, Global Medical Affairs DBV Technologies   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 (NCT03013517) in peanut-allergic children ages 4 to 11 years . Participants who completed the 12-month study period of PEPITES were eligible to enroll in PEOPLE. Patients who were randomized to active treatment in PEPITES are eligible to receive up to four additional years of treatment, and those previously receiving placebo are eligible to receive up to five years of treatment. The current study reports on the 3 year outcomes of children who were initially randomized to receive active treatment in the PEPITES study and completed an additional 2 years of treatment during the PEOPLE study. The study evaluated the eliciting dose (ED) after three years (Month 36) of active treatment using a double-blind, placebo-controlled food challenge (DBPCFC). The starting dose of each challenge was 1 mg of peanut protein and escalated to the highest dose of 2,000 mg peanut protein; possibly repeated once to reach a maximum total cumulative dose of 5,444 mg peanut protein. All participants who reached an ED ≥ 1,000 mg at Month 36 were eligible to continue the study for two additional months without treatment while maintaining a peanut-free diet. A further double-blind placebo-controlled food challenge to determine ED was administered at the end of this period (Month 38). Additional analyses include exploratory assessments of safety parameters, immune biomarkers such as immunoglobulin G4 (IgG4) and immunoglobulin E (IgE).
Allergies, Author Interviews / 15.11.2019

MedicalResearch.com Interview with: [caption id="attachment_51998" align="alignleft" width="189"]Christopher M. Bland, Pharm.D., FCCP, FIDSA, BCPS Clinical Associate Professor Clinical and Administrative Pharmacy University of Georgia College of Pharmacy Clinical Pharmacy Specialist St. Joseph’s/Candler Health System Savannah, GA  Dr. Bland[/caption] Christopher M. Bland, Pharm.D., FCCP, FIDSA, BCPS Clinical Associate Professor Clinical and Administrative Pharmacy University of Georgia College of Pharmacy Clinical Pharmacy Specialist St. Joseph’s/Candler Health System Savannah, GA MedicalResearch.com: What is the background for this study? Response: Nearly 10% of the United States population self-report a penicillin allergy. However 90% of these allergies are found to be false upon reconciliation which includes patient interview, graded challenge, direct challenge, or penicillin skin testing. This is crucial as patients labeled with a penicillin allergy often receive more expensive antibiotics that additionally cause more adverse effects. While reconciling penicillin allergies is an important antimicrobial stewardship goal, resources are often limited in various healthcare settings to accomplish several of these endeavors. Our study evaluated the use of pharmacy students to serve as patient interviewers to aid in reconciling penicillin allergies.
Allergies, Author Interviews, Cancer Research, Pediatrics / 13.11.2019

MedicalResearch.com Interview with: [caption id="attachment_52106" align="alignleft" width="200"]Sairaman Nagarajan, MD Clinical Fellow at State University New York (SUNY) Downstate Medical Center College of Medicine Dr. Nagarajan[/caption] Sairaman Nagarajan, MD Clinical Fellow at State University New York (SUNY) Downstate Medical Center College of Medicine MedicalResearch.com: What is the background for this study? Response: The impetus for this study came from our previous research linking asthma, hay-fever and overall cancer diagnoses using the CDC’s National Health Interview Survey database. The division of Allergy and Immunology at SUNY Downstate has also conducted two pilot studies on the relationship between parental cancer and childhood asthma in Brooklyn’s population; one from Lutheran Medical Center focusing on Hispanics and Asian patients, and the other on African-American and Afro-Caribbean patients.
Allergies, Author Interviews, Electronic Records / 13.11.2019

MedicalResearch.com Interview with: Sonam Sani MD Allergy & Immunology Fellow NYU Winthrop Hospital MedicalResearch.com: What is the background for this study? Response: Penicillin allergy label removal is becoming more common. Studies have shown that while 10% of the general population report an allergy to penicillin, after testing only 1% truly have an allergy. Allergists have the ability to evaluate patient’s for penicillin allergy by performing skin tests and oral challenges. However, even when people test negative for penicillin allergy, they still face barriers to having the label removed. We are noting more and more that despite having negative testing, upon further encounters, our patients still have their penicillin allergy label.
Allergies, Author Interviews, JAMA, Nutrition, Pediatrics / 22.10.2019

MedicalResearch.com Interview with: Mitsuyoshi Urashima MD, PhD, MPH Professor of Molecular Epidemiology Jikei University School of Medicine Tokyo, JAPAN MedicalResearch.com: What is the background for this study? Response: IgE-mediated food allergy is becoming a global concern, because its prevalence and severity are worsening. Many Japanese maternity wards encourage breastfeeding, but allow mothers or nurses to supplement breastfeeding with cow’s milk formula, e.g., approximately 6 to 10 hours after birth or even earlier, based on maternal preferences, but not based on clinical evidence. However, more than 20 to 30 years ago, sugar water was given instead of cow’s milk formula supplement at birth. Thus, we hypothesized that early exposure to cow’s milk formula at birth is, at least in part, associated with the recent increase in children with food allergy. Therefore, a randomized clinical trial, named ABC (Atopy induced by Breast feeding or Cow's milk formula), was conducted to assess whether the risk of cow’s milk formula sensitization and food allergy is decreased by either avoiding or supplementing cow’s milk formula at birth. Immediately after birth, newborns were randomly assigned (1:1 ratio) to either breastfeeding with or without amino acid-based elemental formula for at least the first 3 days of life (breastfeeding ± elemental formula), or breastfeeding supplemented with cow’s milk formula (≥5 mL/day) from the first day of life to 5 months of age (breastfeeding + cow's milk formula).
Allergies, Author Interviews, C. difficile, Dental Research, Infections / 05.10.2019

MedicalResearch.com Interview with: [caption id="attachment_51763" align="alignleft" width="157"]Alan E. Gross, PharmD Clinical Assistant Professor University of Illinois Chicago, IL Dr. Gross[/caption] Alan E. Gross, PharmD Clinical Assistant Professor University of Illinois Chicago, IL MedicalResearch.com: What is the background for this study? Response: Dentists prescribe 10% of all outpatient antibiotics. Most of this prescribing is for infection prophylaxis prior to dental procedures. Our prior research has found that 80% of prescriptions for dental prophylaxis is unnecessary. Although antibiotic prophylaxis prior to dental procedures is often for a short course (e.g. one time amoxicillin dose), there may be patient harm associated with this.
Allergies, Author Interviews, Brigham & Women's - Harvard, CMAJ, Dermatology, Heart Disease / 30.09.2019

MedicalResearch.com Interview with: [caption id="attachment_51631" align="alignleft" width="120"]Hyon K. Choi, MD, DrPH Professor of Medicine, Harvard Medical School Director, Gout and Crystal Arthropathy Center Director, Clinical Epidemiology and Health Outcomes Division of Rheumatology, Allergy, and Immunology Department of Medicine, Massachusetts General Hospital Dr. Choi[/caption] Hyon K. Choi, MD, DrPH Professor of Medicine, Harvard Medical School Director, Gout and Crystal Arthropathy Center Director, Clinical Epidemiology and Health Outcomes Division of Rheumatology, Allergy, and Immunology Department of Medicine, Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Allopurinol is a very common and generally safe medication prescribed to lower serum urate levels, most commonly to patients with gout. However, it can be associated with very rare but serious cutaneous adverse events which includes Stevens-Johnson syndrome and toxic epidermal necrolysis. Prior studies have demonstrated several risk factors for these types of cutaneous adverse events, including presence of chronic kidney disease, older age, female sex, higher initial dose of allopurinol, and the HLA-B*5801 allele, which is more commonly found in Asians and Black patients. A prior study in Taiwan suggested that heart disease (ischemic heart disease and heart failure) may also be associated with an increased risk of hospitalizations for these cutaneous adverse reactions related to allopurinol. Thus, our goal was to investigate this association using a general population cohort from Canada. Using Population Data BC, we found that heart disease was in fact independently associated with an increased risk of hospitalization for these cutaneous adverse reactions.
Allergies, Author Interviews / 06.09.2019

MedicalResearch.com Interview with: [caption id="attachment_51129" align="alignleft" width="133"]Edwin H. Kim, MD, MS Assistant Professor of Medicine & Pediatrics, Division of Rheumatology, Allergy & Immunology Program Director, UNC Allergy and Immunology Fellowship Program Director, UNC Food Allergy Initiative Medical Director, UNC Allergy & Immunology Clinic UNC School of Medicine Chapel Hill, NC Dr. Edwin H. Kim[/caption] Edwin H. Kim, MD, MS Assistant Professor of Medicine & Pediatrics, Division of Rheumatology Allergy & Immunology Program Director, UNC Allergy and Immunology Fellowship Program Director, UNC Food Allergy Initiative Medical Director, UNC Allergy & Immunology Clinic UNC School of Medicine Chapel Hill, NC MedicalResearch.com: What is the background for this study? Response: In 2011, Kim and colleagues – including Wesley Burks, MD, dean of the UNC School of Medicine – conducted a small study of 18 patients to show that sublingual immunotherapy (SLIT) was safe and effective over the course of one year. Since then, Kim and colleagues followed 48 patients in the SLIT protocol of 2 mg daily for five years. In the JACI paper, the researchers showed that 67 percent of these patients were able to tolerate at least 750 mg of peanut protein without serious side effects. About 25 percent could tolerate 5000 mg
Allergies, Author Interviews, Pediatrics, Pharmaceutical Companies / 21.08.2019

MedicalResearch.com Interview with: [caption id="attachment_51005" align="alignleft" width="159"]Todd Green MD Vice President of Medical Affairs North America DBV Technologies Dr. Todd Green[/caption] 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.
Allergies, Author Interviews, Cancer Research, Immunotherapy / 07.06.2019

MedicalResearch.com Interview with: Prof. Olivier Lambotte, MD, PHD Professor of Internal Medicine Paris XI University Medical School Research Director Control of Chronic Viral Infections DepartmentProf. Olivier Lambotte, MD, PHD Professor of Internal Medicine Paris XI University Medical School Research Director Control of Chronic Viral Infections Department MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Immune checkpoint inhibitors (ICIs) anti-programmed death-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) have proven efficacy in the treatment of many cancers but patients may experience immune-related adverse events (irAEs). Immune checkpoint inhibitors is usually stopped when grade 2 or higher irAE occur. Data are very limited  on the safety of resuming treatment after such an event. We  studied all adult patients referred to the ImmunoTOX toxicity review board at the Gustave Roussy cancer center (Villejuif, France) in 2015-2017 with  irAE grade 2 or higher for whom the  rechallenge was questioned. Among 93 patients with a broad spectrum of cancers, 40 patients (43%) were rechallenged with the same anti-PD-1 or anti-PD-L1. The rechallenged and non-rechallenged groups did not differ in terms of age, time to initial irAE, irAE severity, or steroid use. With a median follow-up period of 14 months, the same irAE or a different irAE occurred in 22 patients (55%). The second irAEs were not more severe than the first. Earlier initial toxicity was associated with more frequent irAE recurrence.
Allergies, Author Interviews, Immunotherapy, JAMA / 06.05.2019

MedicalResearch.com Interview with: [caption id="attachment_48976" align="alignleft" width="129"]Dr. Marcus Shaker Dr. Shaker[/caption] Marcus S. Shaker, MD Associate Professor of Pediatrics Associate Professor of Community and Family Medicine Dartmouth-Hitchcock Medical Center MedicalResearch.com: 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.
Allergies, Author Interviews, Immunotherapy, Pediatrics / 18.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48695" align="alignleft" width="162"]Lianne Soller, PhDAllergy Research ManagerUniversity of British ColumbiaVancouver, BC, Canada   Dr. Soller[/caption] 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%). 
Allergies, Author Interviews, Dermatology, Heart Disease, JAMA / 03.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48345" align="alignleft" width="133"]Amber Reck Atwater, M.D.Dermatology Residency Program DirectorAssociate Professor of DermatologyDirector, Contact Dermatitis ClinicDuke Dermatology Dr. Reck Atwater[/caption] Amber Reck Atwater, M.D. Dermatology Residency Program Director Associate Professor of Dermatology Director, Contact Dermatitis Clinic Duke Dermatology  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We completed an evaluation of our Duke Dermatology patients who underwent patch testing for possible allergy to their cardiac devices - pacemakers and defibrillators. From March 1, 2012 to September 15, 2017 we saw 11 patients with suspected allergy to their devices.  Concern for allergy, skin eruption, skin symptoms, and concern for infection were common. 73% of patients had erythema at their implant scars; pruritus and pain were also noted.  Six of our patients had relevant reactions, and the most common allergies were metals, silicone and rubber accelerators. 
Allergies, Author Interviews, Immunotherapy, Lancet / 02.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48331" align="alignleft" width="200"]Arnon Elizur MDDirector, The Institute of Allergy, Immunology & Pediatric PulmonologyYitzhak Shamir Medical CenterZerifin, Israel Dr. Elizur[/caption] Arnon Elizur MD Director, The Institute of Allergy, Immunology & Pediatric Pulmonology Yitzhak Shamir Medical Center Zerifin, Israel MedicalResearch.com: What is the background for this study?   Response: Tree nuts are among the most common food allergies and are a major cause of fatal and near fatal reactions. Patients with tree nut allergy are often allergic to several nuts, further increasing the risk of accidental exposures, dietary limitations, and the emotional burden and anxiety in affected patients. In the past 10 years, oral immunotherapy (OIT) has shown promise as a treatment modality for milk, egg and peanut allergies. However, limited data exists on oral immunotherapy for tree nuts and the treatment is complicated by the high prevalence of co-allergy to several nuts.
Allergies, Author Interviews, Brigham & Women's - Harvard, Pharmacology / 23.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48094" align="alignleft" width="128"]Daniel Reker, PhDKoch Institute for Integrative Cancer ResearchMassachusetts Institute of Technology Dr. Reker[/caption] Daniel Reker, PhD Koch Institute for Integrative Cancer Research Massachusetts Institute of Technology MedicalResearch.com: What is the background for this study? Response: We started thinking more about this topic following a clinical experience five years ago that Dr. Traverso was involved in where a patient suffering form Celiac disease received a prescription of a drug which potentially had gluten. This experience really opened our eyes for how little we knew about the inactive ingredients and how clinical workflows do not currently accommodate for such scenarios. We therefore set up a large scale analysis to better understand the complexity of the inactive ingredient portion in a medication as well as how frequently critical ingredients are included that could potential affect sensitive patients.
Allergies, Author Interviews, Pediatrics / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47726" align="alignleft" width="200"]Todd Green MD Vice President, Medical Affairs North AmericaDBV TechnologiesAssociate Professor of PediatricsUniversity of Pittsburgh School of Medicine Dr. Green[/caption] 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. 
Allergies, Author Interviews, Immunotherapy, JAMA, Pediatrics / 01.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47721" align="alignleft" width="200"]Dr. Matthew GreenhawtDirector, Food Challenge and Research UnitChildren’s Hospital Colorado Dr. Greenhawt[/caption] 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.
Allergies, Author Interviews / 26.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47680" align="alignleft" width="125"]Ruchi Gupta MD MPHMary Ann & J Milburn Smith Senior Scientist in Child Health ResearchDirector, Science & Outcomes of Allergy & Asthma Research (SOAAR) ProgramProfessor of Pediatrics & MedicineClinical Attending    Ann & Robert H. Lurie Children's Hospital of ChicagoInstitute for Public Health and MedicineNorthwestern Feinberg School of Medicine Dr. Gupta[/caption] Ruchi Gupta MD MPH Mary Ann & J Milburn Smith Senior Scientist in Child Health Research Director, Science & Outcomes of Allergy & Asthma Research Professor of Pediatrics & Medicine Clinical Attending Ann & Robert H. Lurie Children's Hospital of Chicago Institute for Public Health and Medicine Northwestern Feinberg School of Medicine [caption id="attachment_47681" align="alignleft" width="125"]Christopher M. Warren,  PhDUniversity of Southern CaliforniaLos Angeles, CA Dr. Warren[/caption]   Christopher M. Warren,  PhD University of Southern California Los Angeles, CA     MedicalResearch.com: What is the background for this study? Response: Readers may be familiar with the so-called "top 8" food allergens (i.e. peanut, tree nut, cow's milk, fin fish, shellfish, egg, wheat and soy), which are responsible for the majority of food allergies in the US.  However, in recent years increasing attention has been paid to sesame allergy, which evidence suggests can lead to anaphylaxis, frequently results in accidental exposure among affected patients, and is infrequently outgrown.  Until now, only one 2010 study has systematically assessed the prevalence of sesame among both US children and adults.  It concluded that sesame allergies were reported by approximately .1% of the US population. However, this study, which surveyed a sample of approximately 5000 US households only captured 13 individuals with reported sesame allergy, which limited the authors' ability to draw more detailed conclusions about the specific characteristics of sesame allergy in the United States.