Allergies, Author Interviews / 20.07.2020
Peanut Allergy: Three Year Study of Viaskin Immunotherapy Demonstrates Long Term Safety and Efficacy in Children
MedicalResearch.com Interview with:
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Dr. Green[/caption]
Dr. Todd Green
Vice President of Clinical Development and Medical Affairs
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).
Dr. Green[/caption]
Dr. Todd Green
Vice President of Clinical Development and Medical Affairs
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). 
Samia Arshad[/caption]
Samia Arshad, MPH
Epidemiologist II
Infectious Disease
Henry Ford Hospital, Detroit, MI
I would like to start off by saying: We need to keep partisanship out of science. During this pandemic, we hope we can stick to science and help save lives with purposeful data driven facts.
MedicalResearch.com: What is the background for this study?
Response: Hydroxychloroquine, an antimalarial and immunomodulatory agent has demonstrated antiviral activity against SARS-CoV-2. We are in an acceleration phase of the COVID-19 pandemic, with 25% of the world’s cases occurring in the United States. Currently there is no known therapy or vaccine for treatment of SARS-CoV-2, highlighting the urgency around identifying effective therapies. The purpose of this study was to evaluate the role of hydroxychloroquine therapy alone and in combination with azithromycin in hospitalized patients positive for COVID-19. 
Dr. Zhang[/caption]
Ruiyuan Zhang, MD, MS
Department of Epidemiology and Biostatistics
University of Georgia College of Public Health
Athens, Georgia
MedicalResearch.com: What is the background for this study?
Response: Although there are several studies that focused on the effect of alcohol drinking on cognitive function, their findings were still mixed. So we want to use some new analysis techniques on this topic to see if we can have new findings.
MedicalResearch.com: What are the main findings?
Response: The main finding of our study is that low-to-moderate alcohol drinking is associated with better cognitive function outcomes.
Dr. Trudo[/caption]
Frank Trudo, MD MBA
Vice President, US Medical Affairs
Respiratory & Immunology
AstraZeneca
MedicalResearch.com: What is the background for this study?
Response: ETHOS is a randomized, double-blinded, multi-center, parallel-group, 52-week trial to assess the efficacy and safety of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations.
MedicalResearch.com: How does PT010 differ from other treatments for COPD?
Dr. Erdlenbruch[/caption]
Response: At the World Federation of Hemophilia Virtual Summit 2020 (WFH 2020), 
Dr. Desai[/caption]
Nimesh D. Desai, MD, PhD
Director, Thoracic Aortic Surgery Research Program
Associate Professor of Surgery
Hospital of the University of Pennsylvania
MedicalResearch.com: What is the background for this study?
Dr. Chase Brown: Opioid use in the United States is a public health emergency. We know that opioids prescribed after general surgery operations to patients who never received them within the year prior to their surgery are at increased risk for continuing to take opioids months later. However, this has not been studied in patients undergoing cardiac surgery, who often times have more severe post-operative pain.
Our goal in this study was to determine how many patients after cardiac surgery and are opioid naive are continuing to take opioids within 90-180 days after their surgery. 
Dr. Vandrey[/caption]
Ryan Vandrey, Ph.D.
Associate Professor
Behavioral Pharmacology Research Unit
Johns Hopkins University School of Medicine
Baltimore, MD 21224
MedicalResearch.com: What is the background for this study?
Response: The background for this study is that 33 states in the U.S. have legalized medicinal cannabis use and millions of people are using cannabis for therapeutic purposes, but we have very little data on the broad health impacts of medicinal cannabis use.
We surveyed medicinal cannabis users and non-using controls who had a variety of health problems and found that the cannabis users reported better health, quality of life, and less healthcare utilization compared with controls. Because we worried about group characteristics accounting for the differences observed, we then did an analysis of people who switched groups over time (e.g. non-users who later initiated cannabis use or cannabis users who later quit) and found the same differences emerged in the same individuals over time. Important to note here is that not all individuals who used cannabis benefited from it and that most participants were using high CBD varieties of cannabis in conjunction with more traditional treatments.
Dr. Al-Hendy[/caption]
MedicalResearch.com: What is the background for this approval?
Uterine fibroids, commonly referred to as uterine leiomyomas, are the most common type of non-cancerous tumor known to impact women of reproductive age (30-50 years old). In fact, studies show that uterine fibroids can occur in up to 70 percent of European American women and over 80 percent of African American women by age 50. As a result of uterine fibroids, women can experience a range of symptoms, the most common being heavy menstrual bleeding (i.e. prolonged and/or frequent bleeding), which can lead to other health effects such as anemia, fatigue, pelvic pain, urinary frequency etc.
Uterine fibroid treatment recommendations have historically been based on the size and location of the fibroid(s). When treating larger and more complicated fibroids, healthcare providers have typically believed that surgery is their best course of action, which has made uterine fibroids the leading reason for the hysterectomies performed in the U.S. The FDA approval of ORIAHNN was based on improving care for uterine fibroid sufferers who have had a negative impact on their quality of life due to disruptive symptoms. What makes the approval of ORIAHNN so exciting, is that women now have an oral therapy to directly address heavy menstrual bleeding due to uterine fibroids.
Dr. Kempe[/caption]
Allison Kempe, MD, MPH
Ergen Family Endowed Chair in Pediatric Outcomes Research
Professor of Pediatrics, University of Colorado School of Medicine
Director of ACCORDS (Adult and Child Consortium for Health Outcomes Research and Delivery Science)
University of Colorado School of Medicine | Children’s Hospital Colorado
MedicalResearch.com: What is the background for this study?
Response: In 2019 the WHO designated vaccine hesitancy as one of the ten leading threats to global health. Although studies have assessed parental vaccine hesitancy in different localities and estimated vaccine refusals nationally, there is little recent US national data on the prevalence of hesitancy about routine childhood vaccines and national hesitancy rates for influenza vaccine have never been assessed. We used a hesitancy scale developed by the WHO to estimate levels of parental hesitancy for both routine childhood and childhood influenza vaccination 
Dr. Crowley[/caption]
Matthew J. Crowley, MD
Core Investigator, Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)
Affiliated Investigator, VA Office of Rural Health
Staff Physician, Endocrinology Section, Durham VA Health Care System
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Dr. Paller[/caption]
Amy S Paller, MD
Chair, Department of Dermatology
Director, Skin Biology and Diseases Resource-Based Center
Walter J. Hamlin Professor of Dermatology
Professor of Dermatology and Pediatrics (Dermatology)
Feinberg School of Medicine
Northwestern University
Dr. Paller discusses the FDA approval of Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis (eczema), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
MedicalResearch.com: What is the background for this announcement? Would you briefly discuss what is meant by atopic dermatitis and how it affects children?
Response: “Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that often appears as a rash on the skin. Moderate-to-severe atopic dermatitis is characterized by rashes that can potentially cover much of the body and can include intense, persistent itching, skin lesions and skin dryness, cracking, redness or darkness, crusting and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating.
This recent FDA approval expands the use of Dupilumab in the U.S. to include children aged 6 to 11 years with uncontrolled moderate-to-severe atopic dermatitis, making it the only biologic medicine approved for this use in this population. Dupilumab is also approved in the U.S. to treat patients aged 12 years and older with moderate-to-severe atopic dermatitis.
Moderate-to-severe atopic dermatitis can place a particularly substantial burden on young children aged 6 to 11 years and their families. Limited treatment options leave many of these children to cope with intense, unrelenting itch and skin lesions. Families of these children can spend countless hours helping them to manage their disease.”
Dr. Blume[/caption]
Dr. Christine Blume PhD
Centre for Chronobiology
Psychiatric Hospital of the University of Basel
Transfaculty Research Platform Molecular and Cognitive Neurosciences
Basel
MedicalResearch.com: What is the background for this study?
Response: In modern societies, human rest-activity rhythms and sleep are between the often-conflicting poles of external social time (e.g., work hours and leisure activities) and an individual’s internal biological time. This can lead to so-called “social jetlag”, which has repeatedly been associated with detrimental health effects. With the restrictions to control the pandemic, social timing relaxed as people many started working from home and public life came to a standstill. In an online survey with 435 respondents, we investigated the effects of the phase with the strictest COVID-19 restrictions on the relationship between social and biological rhythms as well as sleep during a six-week period (mid-March until end of April 2020) in three European societies (Austria, Germany, Switzerland).