Asthma, Author Interviews, JAMA, Karolinski Institute, Pediatrics / 08.02.2021

MedicalResearch.com Interview with: [caption id="attachment_56576" align="alignleft" width="150"]Yun-Han Wang PhD student, Karolinska Institute Yun-Han Wang[/caption] Yun-Han Wang MSc PhD student, Karolinska Institute MedicalResearch.com: What is the background for this study? Response: The use of proton pump inhibitors (PPIs) in children has increased substantially in recent years, concurrently with emerging concerns that these drugs may increase the risk of asthma. Whether PPI use in the broad pediatric population is associated with increased risk of asthma is not known. 
Asthma, AstraZeneca, Author Interviews / 01.12.2020

MedicalResearch.com Interview with: [caption id="attachment_56091" align="alignleft" width="200"]Dr-Frank Trudo Dr. Frank Trudo[/caption] Frank Trudo, MD MBA Vice President, US Medical, Respiratory & Immunology AstraZeneca  MedicalResearch.com: What is the background for this study? Response: PONENTE is a multicenter, open-label, single-arm, Phase IIIb trial to evaluate the efficacy and safety of reducing daily oral corticosteroids (OCS) use after initiation of 30 mg dose of FASENRA (benralizumab) administered subcutaneously in adult patients with severe eosinophilic asthma on high-dose inhaled corticosteroids plus long-acting beta2-agonist and long-term use of OCS therapy with or without additional asthma controller(s). The trial expands on OCS-sparing data previously seen in the ZONDA Phase III trial by using a faster steroid tapering schedule in patients who did not experience adrenal insufficiency to reduce OCS use from higher doses. Compared to published trials of other biologics, PONENTE has a personalized OCS tapering schedule that allows for more rapid OCS tapering from higher OCS doses, followed by an assessment of the adrenal function as part of decision-making to manage the risk of adrenal insufficiency. PONENTE also has a longer maintenance phase (approximately 24-32 weeks), allowing assessment of the durability of OCS reduction. FASENRA is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death). MedicalResearch.com: How is it administered?  Response: FASENRA is injected under your skin (subcutaneously) one time every 4 weeks for the first 3 doses, and then every 8 weeks. In 2019, FASENRA was approved in the US for self-administration in a single dose prefilled autoinjector, the FASENRA pen.
Asthma, Author Interviews / 03.11.2020

MedicalResearch.com Interview with: https://www.gsk.com/en-gb/home/Beth Hahn, PhD, Director U.S. Value Evidence and Outcomes, GlaxoSmithKline, Research Triangle Park, NC MedicalResearch.com: What is the background for this study? Response: Biologic therapies are increasing as a treatment for patients with severe asthma, with multiple therapies approved by the FDA.  There is also an increasing understanding of the factors influencing preference for and adherence to biologic therapies for patients with severe asthma; however, little is known about why patients discontinue biologic therapy. In patients who have access to biologic treatment, understanding the circumstances and asthma characteristics associated with discontinuation of biologic therapy may allow for the identification of barriers to treatment success . The objective of this study of cross-sectional physician and patient survey data was to assess the patient characteristics and the given reasons for treatment discontinuation in a US patient cohort with severe asthma treated with biologic therapy. A total of 117 physicians and 285 patients completed surveys with 70% of patients continuing biologic therapy (N=200). This study included a number of different FDA approved biologics. From the perspectives of the physicians included in the current study (85 providing a rationale for discontinuation), the majority reported a lack of symptom control, particularly shortness of breath (46%), exacerbations (26%) and other chronic symptoms (29%), as a key reason for discontinuing biologic therapy in severe asthma. Symptom control was also key for patients, with these three symptom categories among their top six reasons for biologic discontinuation. The cost of biologic treatment was also an important factor, cited as the 5th most common reason for discontinuation among physicians and the 3rd among patients.
Asthma, Author Interviews, BMJ, Osteoporosis / 21.10.2020

MedicalResearch.com Interview with: [caption id="attachment_55667" align="alignleft" width="200"]Christos Chalitsios B.Sc, M.Sc PhD student Funded by British Medical Association (BMA) School of Medicine Division of Respiratory Medicine University of Nottingham City Hospital,Nottingham Christos V. Chalitsios[/caption] Christos Chalitsios B.Sc, M.Sc PhD student Funded by British Medical Association (BMA) School of Medicine Division of Respiratory Medicine University of Nottingham City Hospital,Nottingham MedicalResearch.com: What is the background for this study? Response: Inhaled (ICS) and oral (OCS) corticosteroids play a crucial role in the control of airway inflammation in asthma. Given that the use of ICS in asthma is likely to increase with the recent change in GINA guidance recommending combined long-acting-β2-agonists with ICS at step 1 and the upward trend in prescribing of OCS, we sought to clarify the link between steroids, osteoporosis and FF in patients with asthma, stratifying the risk by dose, number of courses and type of steroids. The prevalence of patients receiving at least one bisphosphonate was also calculated.
Author Interviews, Pediatrics, Vitamin D / 28.08.2020

MedicalResearch.com Interview with: [caption id="attachment_55194" align="alignleft" width="158"]Juan C. Celedón, MD, DrPH, ATSF Niels K. Jerne Professor of Pediatrics Professor of Medicine, Epidemiology and Human Genetics University of Pittsburgh Division Chief, Pulmonary Medicine UPMC Children’s Hospital of Pittsburgh Pittsburgh, PA 15224 Dr. Celedón[/caption] Juan C. Celedón, MD, DrPH, ATSF Niels K. Jerne Professor of Pediatrics Professor of Medicine, Epidemiology and Human Genetics University of Pittsburgh Division Chief, Pulmonary Medicine UPMC Children’s Hospital of Pittsburgh Pittsburgh, PA 15224 MedicalResearch.com: What is the background for this study? Response: Findings from observational studies suggested that vitamin D levels below 30 ng/ml are associated with worse asthma and severe asthma attacks. Based on those results, we conducted a randomized, double-blind, placebo-controlled clinical trial of vitamin D3 supplementation to prevent severe asthma attacks in 192 high-risk children with asthma aged 6 to 16 years who had moderately low vitamin D levels and were taking low-dose inhaled steroids.
Asthma, AstraZeneca, Author Interviews / 22.08.2020

MedicalResearch.com Interview with: [caption id="attachment_54747" align="alignleft" width="125"]Frank Trudo, MD MBA Vice President, US Medical Affairs Respiratory & Immunology AstraZeneca Dr. Frank Trudo[/caption] Frank Trudo, MD MBA Vice President, US Medical Affairs Respiratory & Immunology AstraZeneca     MedicalResearch.com: What is the background for this study?
  • Multiple pathways drive asthma. T2 inflammation-driven asthma is present in many patients with severe asthma and is typically characterized by elevated levels of T2 inflammatory biomarkers, including blood eosinophils, serum IgE and fractional exhaled nitric oxide.
    • Some patients with severe asthma do not present with increased T2 inflammation. However, currently available biologic therapies only target T2-driven inflammation.
  • The PATHWAY trial evaluated the efficacy and safety of three dose regimens of tezepelumab versus placebo as an add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma despite receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers. Overall, the trial showed tezepelumab significantly reduced annualized asthma exacerbation rates of 71%.
  • This post-hoc analysis presented virtually at ATS evaluated the effect of Tezepelumab treatment on asthma exacerbation rates on a seasonal and weekly basis.
Asthma, AstraZeneca, Author Interviews / 06.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54115" align="alignleft" width="200"]Ubaldo Martin MD VP Clinical Respiratory RIA Late Stage Development AstraZeneca Dr. Martin[/caption] Ubaldo Martin MD VP Clinical Respiratory RIA Late Stage Development AstraZeneca MedicalResearch.com: What is the background for this study? Response: BORA was an extension study evaluating the long-term safety and specific aspects of efficacy in patients who had previously been in the benralizumab pivotal studies.  After the patients completed the pivotal studies (Calima, Sirocco and Zonda), they were eligible to join BORA which followed adults for an additional year and adolescent for an additional 2 years.  All patients receive one of two dosages of benralizumab.  The abstract reports the outcomes of adolescents in the BORA study who were followed for approximately 3 years in total.
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.
Asthma, AstraZeneca, Author Interviews, Cost of Health Care / 01.05.2020

MedicalResearch.com Interview with: Yen Chung, PharmD Payer Evidence Director US Medical Affairs, AstraZeneca MedicalResearch.com: What is the background for this study? Response: Among patients with persistent asthma, use of systemic corticosteroids (SCS) is typically reserved for treatment of asthma exacerbations and as a supplemental maintenance therapy for patients whose disease remains uncontrolled with maximum maintenance controller therapies. However, SCS therapy comes with known risks for acute and chronic complications. It is well established that patients with severe asthma are responsible for a disproportionate amount of the economic burden of asthma;  however, less clear is the extent to which systemic corticosteroids use and its consequences specifically contributes to the cost burden of asthma. The purpose of this study was to use administrative claims to follow asthma patients with and without SCS treatment for up to 3 years and compare their complication rates, health care resource utilization, and costs. 
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. 
Asthma, Author Interviews, Genetic Research, Nature / 28.02.2020

MedicalResearch.com Interview with: [caption id="attachment_53322" align="alignleft" width="92"]Zbigniew Zasłona PhD Luke A. J. O’Neill PhD Professor (Chair of Biochemistry) School of Biochemistry and Immunology Trinity Biomedical Sciences Institute Trinity College Dublin, Dublin, Ireland Dr. Zasłona and Dr. ONeill[/caption] Zbigniew Zasłona PhD Luke A. J. O’Neill PhD Professor (Chair of Biochemistry) School of Biochemistry and Immunology Trinity Biomedical Sciences Institute Trinity College Dublin, Dublin, Ireland  MedicalResearch.com: What is the background for this study? Response: Asthma is the most common disease in childhood and the most common respiratory condition in Ireland. It is a disease of environmental and genetic components. It is important to point out that although Ireland has very good air quality, asthma prevalence is very high (the second highest in Europe), and although asthma is not a single gene disease (such as cystic fibrosis) it is very important to study genetic variations in Irish population. Therefore in this study we put emphasis on the genetic component of asthma, rather than environmental factors, especially given that asthma heritability has been estimated as high as 60%. Prevention of asthma by reducing exposure to common risk factors, such as air pollution, will not stop the asthma epidemic in Ireland, as inferior air quality is not an issue.
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.
Asthma, Author Interviews, Brigham & Women's - Harvard, NEJM, Pediatrics, Vitamin D / 10.02.2020

MedicalResearch.com Interview with: [caption id="attachment_53065" align="alignleft" width="133"]Augusto A. Litonjua, M.D., M.P.H. Professor - Department of Pediatrics, Pulmonology Interim Chief - Department of Medicine , Pulmonary Diseases and Critical Care Professor - Department of Medicine , Pulmonary Diseases and Critical Care University of Rochester Dr. Litonjua[/caption] Augusto A. Litonjua, M.D., M.P.H. Professor - Department of Pediatrics, Pulmonology Interim Chief - Department of Medicine , Pulmonary Diseases and Critical Care Professor - Department of Medicine , Pulmonary Diseases and Critical Care University of Rochester MedicalResearch.com: What is the background for this study? Response: Vitamin D deficiency and insufficiency is prevalent worldwide. Prior observational studies have shown that low vitamin D levels have been associated with the development of asthma. Animal studies have reported that antenatal vitamin D is important for lung development in utero. Thus, we conducted a randomized, double-blind, controlled trial of vitamin D supplementation in pregnant women to see if we could prevent the development of asthma and wheezing illnesses in young children. The initial report of the trial results showed that children born to mothers in the vitamin D supplementation arm had lower risks for developing either asthma or recurrent wheezing episodes over the first 3 years, but this was not statistically significant (p=0.051)(Litonjua et al. JAMA 2016).
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.
Asthma, Author Interviews, Environmental Risks, Lancet, Pediatrics / 12.04.2019

MedicalResearch.com Interview with: Ploy Pattanun Achakulwisut, PhD Postdoctoral Scientist in Climate change, Air pollution, and Public Health Milken Institute School of Public Health (Anenberg Group The George Washington University, D.C  MedicalResearch.com: What is the background for this study? Response: Dozens of epidemiological studies have found positive and generally statistically significant associations between long-term exposure to traffic-related air pollution (TRAP) and asthma development in children. The evidence is most robust for nitrogen dioxide (NO2), a major component of and commonly used surrogate for the complex TRAP mixture. Recent reviews conducted by the US Environmental Protection Agency and Health Canada concluded that there is “likely a causal relationship” between long-term NO2 exposure and pediatric asthma development. Using NO2 as a proxy for TRAP, our study provides the first global estimate of the number of new asthma cases among children that are attributable to traffic pollution, using fine spatial-scale global datasets that can resolve within-city and near-roadway NO2 exposures.
Asthma, Author Interviews, JAMA, OBGYNE, Pediatrics, Vitamin D / 12.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47908" align="alignleft" width="133"]Bo Chawes, MD, PhD, DMScAssociate ProfessorC‌openhagen Prospective Studies on Asthma in ChildhoodH‌erlev and G‌entofte H‌ospitalU‌niversity of C‌openhagen Dr. Chawes[/caption] Bo Chawes, MD, PhD, DMSc Associate Professor C‌openhagen Prospective Studies on Asthma in Childhood H‌erlev and G‌entofte H‌ospital U‌niversity of C‌openhagen MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been a global surge in vitamin D deficiency happening in parallel with an increase in prevalence of childhood asthma, which suggests that low maternal vitamin D levels during pregnancy may increase asthma risk in the child. Due to that we conducted a randomized double-blinded controlled trial within the Danish COPSAC2010 cohort (www.copsac.com) of 7-fold (2,800 IU/d) vs. standard dose (400 IU/d) of vitamin D supplementation from pregnancy week 24 aiming to reduce offspring asthma risk. At age 3, we observed a non-significant 24% reduced risk of recurrent asthma-like symptoms, ie. recurrent wheeze, in the high-dose vitamin D group. In the current study, we followed 545 of the 581 children in the study till age 6, where an asthma diagnosis can be established and observed no effect of the high-dose vitamin D supplement on the child's risk of asthma. 
Antibiotic Resistance, Asthma, Author Interviews, JAMA / 04.02.2019

MedicalResearch.com Interview with: Mihaela S Stefan, MD, PhD FACP Research Scientist, Institute for Healthcare Delivery and Population Science Associate Professor, UMMS-Baystate Director of Perioperative Clinic and Medical Consultation Program Academic Hospitalist Director Quality Assessment, Division of Healthcare Quality Springfield MA MedicalResearch.com: What is the background for this study? What are the main findings? Response: In a prior study we have found that roughly 41% of patients hospitalized with an asthma exacerbation receive antibiotics although the guidelines do not support this practice. We found that the evidence supporting the guidelines was however limited to 6 trials which included a total of only 681 adults and children and most trials’ outcomes were symptoms or lung function not length of stay, need for mechanical ventilation, readmissions or death. We performed the largest observational study to-date of approximately 20 000 patients hospitalized for asthma exacerbation and found that patients treated with antibiotics did not have better outcomes but instead they had longer hospital stay and an increased risk for antibiotic-related diarrhea.
Asthma, AstraZeneca, Author Interviews, Pulmonary Disease / 22.11.2018

MedicalResearch.com Interview with: “Asthma Inhaler” by NIAID is licensed under CC BY 2.0Sean O'Quinn MPH Director, Patient Reported Outcomes AstraZeneca  MedicalResearch.com: What is the background for this study? How does benralizumab differ from traditional medications for asthma? Response:  FASENRA™ (benralizumab 30mg for subcutaneous injection as add-on maintenance therapy in severe eosinophilic asthma for patients 12 years and older) has a strong clinical profile, including powerful efficacy against exacerbations and the ability to improve lung function. Benralizumab is a respiratory biologic that binds directly to the IL-5α receptor on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis. (NOTE: The mechanism of action of FASENRA in asthma has not been definitively established.) Benralizumab is not indicated for treatment of other eosinophilic conditions or for relief of acute bronchospasm or status asthmaticus. The most common adverse reactions include headache and pharyngitis. Dependence on rescue medications is indicative of poor asthma control. In the Phase III SIROCCO/CALIMA trials, patients with severe eosinophilic asthma had significantly reduced exacerbation frequency and improved lung function when treated with benralizumab 30mg Q8W (first three doses Q4W) vs. placebo. Less was known about the effects of benralizumab on rescue medication usage—specifically daily total rescue medication use, daytime and nighttime rescue medication use, and nighttime awakenings requiring rescue medication use. The aim of this analysis was to understand the potential treatment effects of benralizumab on these parameters. 
Allergies, Asthma, Author Interviews, Pediatrics, Science / 16.11.2018

MedicalResearch.com Interview with: "Dogs and Kids Mix Well" by Tony Alter is licensed under CC BY 2.0Catarina Almqvist Malmros MD, PhD Professor | Consultant Pediatrician Dept of Medical Epidemiology and Biostatistics | Karolinska Institutet Lung and Allergy Unit | Astrid Lindgren Children’s Hospital Stockholm, Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: We have previously shown an association between growing up with dogs and a lower risk of childhood asthma (doi: 10.1001/jamapediatrics.2015.3219) but it has been unknown whether this link is modified by characteristics of the dog. Sex of the dog may have an effect on expressed allergens, and uncastrated male dogs release more of a certain allergen than castrated male dogs and female dogs. Some breeds are also described as ‘hypoallergenic’, but there is no scientific evidence whether they are more suitable for people with allergies. We examined how variables such as sex, breed, number of dogs or size of dog are associated with the risk of asthma and allergy among children with a dog in their home during the first year of life. We included all Swedish children born between January 2001 and December 2004 whose parents had a registered dog in a dog-owner register and linked the data to the Swedish population- and health data registers. Main findings are that children raised with only female dogs at home had a 16 per cent lower risk of asthma than those with male dogs, and that children living with two or more dogs had a 21 per cent lower risk of asthma than those with only one dog. Importantly, families with parental asthma or allergies had ‘hypoallergenic’ breeds more often than children whose parents did not have asthma or allergies; 11.7% compared to 7.6 . Exposure to these breeds was associated with a 27 per cent higher risk of allergy and no decreased risk of asthma. 
Asthma, Author Interviews, FDA, Regeneron / 31.10.2018

MedicalResearch.com Interview with: RegeneronNeil Graham,  M.B.B.S., M.D., M.P.H VP of Immunology & Inflammation Regeneron MedicalResearch.com: What is the background for this announcement?  Response: Patients with moderate-to-severe asthma often have uncontrolled, persistent symptoms despite standard-of-care therapy that may make them suitable for treatment with a biologic therapy. They live with coughing, wheezing and difficulty breathing, and are at risk of severe asthma attacks that may require emergency room visits or hospitalizations. [i],[ii] Oral corticosteroids can provide relief for severe, short-term symptoms. However, their chronic use is limited to the most severe patients due to the potential for serious side effects. [iii],[iv] A particular type of inflammation contributes to the cause of uncontrolled symptoms in multiple inflammatory diseases such as asthma and atopic dermatitis.[v] Dupixent is a medicine that inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to this type of inflammation. This inhibits cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE; however, the mechanism of action of Dupixent in asthma has not been definitively established.
Asthma, AstraZeneca, Author Interviews, Pulmonary Disease / 20.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44683" align="alignleft" width="200"]Tosh Butt, MBA VP Respiratory AstraZeneca Tosh Butt[/caption] Tosh Butt, MBA VP Respiratory AstraZeneca MedicalResearch.com: What is the background for this study? How is benralizumab different from more traditional treatments for asthma?
    • BORA is a randomized, double-blind, parallel-group, Phase III extension, and is one of six Phase III trials in the WINDWARD program in asthma. The current analysis includes results for 1,926 patients from the two placebo controlled exacerbation trials, SIROCCO (48 week) and CALIMA (56 weeks). BORA provides evidence that add on maintenance treatment with FASENRA (benralizumab) resulted in a consistent safety profile over a second year of treatment, with no increase in the frequencies of overall or serious adverse events, and sustained efficacy in terms of reducing asthma exacerbations, and improving lung function and asthma symptoms. The BORA trial results could provide confidence to patients with severe eosinophilic asthma and physicians that the positive outcomes they may be seeing with benralizumab can be maintained over a second year of treatment.
  • FASENRA, a different kind of respiratory biologic, has a strong clinical profile which includes the ability to show lung function improvement after the first dose, the potential to reduce – or even stop - oral steroid use, and the convenience of 8-week dosing (no other respiratory biologic offers this dosing). FASENRA is approved for add-on maintenance treatment of patients with severe asthma ages 12 years and older, and with an eosinophilic phenotype. FASENRA binds directly to the IL-5a receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis, or cell death. Other biologics currently available are anti-IL5s – a passive approach that primarily acts to block differentiation and survival of the eosinophil.
Asthma, Author Interviews, Heart Disease, JAMA / 11.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43088" align="alignleft" width="128"]Aivaras Cepelis, MSci Department of Public Health and Nursing, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology Trondheim, Norway Aivaras Cepelis[/caption] Aivaras Cepelis, MSci Department of Public Health and Nursing, Faculty of Medicine and Health Science NTNU, Norwegian University of Science and Technology Trondheim, Norway MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation is the most common sustained, irregular and often rapid heart rate with a lifetime risk of 26%. The number of adults with atrial fibrillation is projected to double by 2050. Atrial fibrillation is also linked to adverse cardiovascular outcomes such as doubled risk of stroke and cardiovascular mortality. Therefore, we believe that research into the novel risk factors of the disease is highly warranted. One of the potential condition that could play a role in the growing prevalence of atrial fibrillation is asthma. Asthma is a chronic inflammatory airway disease, affecting as many as 30 million children and adults in Europe. High levels of systemic inflammation biomarkers have been reported in both uncontrolled asthmatics and patients with atrial fibrillation. Furthermore, beta-agonists, the most common prescribed asthma control medication, has been shown to influence heart rate and increase the risk of irregular heartbeat. However, research looking at asthma and atrial fibrillation link are lacking and no previous studies have assessed the dose-response relationship between levels of asthma control and atrial fibrillation. We utilized over 54 000 adults from a large well-defined Norwegian population cohort The Nord-Trøndelag Health Study (HUNT) to explore this association.
Asthma, AstraZeneca, Author Interviews, Immunotherapy, Lancet, Pulmonary Disease / 27.06.2018

MedicalResearch.com Interview with: [caption id="attachment_42814" align="alignleft" width="141"]Reynold A. Panettieri, Jr., M.D. Professor of Medicine, Robert Wood Johnson Medical School Vice Chancellor, Clinical & Translational Science Director, Rutgers Institute for Translational Medicine & Science Emeritus Professor of Medicine, University of Pennsylvania Child Health Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, NJ  08901 Dr. Panettieri[/caption] Reynold A. Panettieri, Jr., M.D. Professor of Medicine, Robert Wood Johnson Medical School Vice Chancellor, Clinical & Translational Science Director, Rutgers Institute for Translational Medicine & Science Emeritus Professor of Medicine, University of Pennsylvania Child Health Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, NJ  08901 MedicalResearch.com: What is the background for this study? Response: Severe asthma is characterized by Type 2 inflammation manifested by increases in IL-13, IL-4 and Il-5 levels in the airways that promotes airway hyperresponsiveness and in part irreversible airway obstruction.  These clinical manifestations profoundly increase asthma morbidity and mortality. To address an unmet therapeutic need, Tralokinumab was developed as a monoclonal antibody targeting soluble IL-13 with the goal of improving lung function and patient reported outcomes while decreasing annual exacerbation rates.  Stratus 1 and 2 represent two identical randomized, double-blind, placebo-controlled, phase 3 clinical trials in severe asthma.  These international trials enrolled approximately 2000 subjects with severe asthma and examined whether Tralokinumab decreased annualized exacerbation rates (AER) as compared with placebo (primary outcome).
Asthma, Author Interviews, Biomarkers / 12.06.2018

MedicalResearch.com Interview with: Dr. Supinda Bunyavanich MD Pediatric Allergy and Immunology Physician and researcher at the Icahn School of Medicine. MedicalResearch.com: What is the background for this study? What are the main findings?  Response: In this study, we report on an accurate asthma biomarker we have developed based on a simple nasal brush. Nasal Brush-based Classifier of Asthma Asthma is a chronic respiratory disease that affects 10% of children and adults in the U.S. Mild to moderate asthma can be difficult to diagnose because symptoms change over time and can be complicated by other respiratory conditions. Given the high prevalence of asthma, there is high potential impact of improved diagnostic tools on reducing morbidity and mortality from asthma. Current diagnostic tools for asthma, including spirometry and bronchoscopy, require specialized equipment and expertise to operate properly. Many individuals, particularly young children, have difficulty with pulmonary function testing because it requires, coordinated, forced breaths into a device. Spirometry results are unreliable when done with poor technique. Bronchoscopy is not practical for mild to moderate symptoms. For these reasons, asthma is often diagnosed and managed based on self-reporting of symptoms  This can be unreliable, resulting in repeated doctor visits and even trips to the ER. Thus, a biomarker test for asthma that is easy to implement and interpret is highly desirable for the diagnosis and management of asthma.
Asthma, Author Interviews, NEJM / 22.05.2018

MedicalResearch.com Interview with: [caption id="attachment_41963" align="alignleft" width="133"]Mario Castro, M.D., M.P.H. Alan A. and Edith L. Wolff Professor of Pulmonary and Critical Care Medicine, Professor of Medicine, Pediatrics, and Radiology Washington University School of Medicine  Drr. Castro[/caption] Mario Castro, M.D., M.P.H. Alan A. and Edith L. Wolff Professor of Pulmonary and Critical Care Medicine, Professor of Medicine, Pediatrics, and Radiology Washington University School of Medicine  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This is a confirmatory phase 3 pivotal study that assessed the efficacy and safety of dupilumab in a population of uncontrolled moderate to severe asthmatics. This was the largest phase 3 placebo controlled trial conducted in this population evaluating a biologic. It enrolled patients without any minimum requirement for any type of biomarker such as blood eosinophils. It clearly confirmed the efficacy of dupilumab in reducing severe asthma exacerbations, improving lung function, asthma control and quality of life in the overall population. It also showed that patients with evidence of type 2 inflammation (increased blood eosinophils or exhaled NO) had a greater magnitude of effect.
Asthma, Author Interviews, NEJM, Pulmonary Disease / 09.03.2018

MedicalResearch.com Interview with: “Asthma Inhaler” by NIAID is licensed under CC BY 2.0Timothy Harrison, MBBS, BSc, FRCP, MD, MSc Professor and Honorary Consultant Faculty of Medicine & Health Sciences University of Nottingham MedicalResearch.com: What is the background for this study? What are the main findings? Response: Self management plans are recommend for patients with asthma but previous studies have shown that doubling the dose of inhaled steroids when asthma starts deteriorating is ineffective at preventing the development of an exacerbation. This study shows that quadrupling the dose is effective and in a real-life setting can reduce severe exacerbations by about 20%
Asthma, Author Interviews, Microbiome, Pediatrics / 15.12.2017

MedicalResearch.com Interview with: [caption id="attachment_38946" align="alignleft" width="149"]Anita Kozyrskyj, PhD, Professor, Dept Pediatrics Faculty of Medicine & Dentistry, University of Alberta Edmonton, AB  Dr. Kozyrskyj[/caption] Anita Kozyrskyj, PhD, Professor, Dept Pediatrics Faculty of Medicine & Dentistry, University of Alberta Edmonton, AB   MedicalResearch.com: What is the background for this study? What are the main findings? Response: I was motivated to study the maternal asthma-infant microbiome link by the well-established fact that maternal asthma affects infant birth weight in a sex-specific manner. Based on data from AllerGen’s CHILD birth cohort, Caucasian baby boys born to pregnant moms with asthma—putting them at the highest risk for developing asthma in early childhood—were one-third as likely to have high levels of the microbe, Lactobacillus, in their gut microbiome at 3-4 months after birth.
Asthma, Author Interviews, Dermatology, Pediatrics / 20.11.2017

MedicalResearch.com Interview with: “Eczema” by NIAID is licensed under CC BY 2.0Malcolm R. Sears, MB ChB Firestone Institute for Respiratory Health St Joseph's Healthcare and McMaster University Ontario Canada.  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Canadian Healthy Infant Longitudinal Development (CHILD) Study was initiated in 2008, funded by AllerGen NCA and CIHR, to determine root causes of allergy and asthma. We recruited 3623 pregnant mothers in 4 centers across Canada and are following 3495 eligible children from pregnancy to age 5 years. In this paper we describe some of the findings in early childhood, namely that children who develop skin conditions generally called eczema or atopic dermatitis, who are also sensitized to food allergens (milk, egg, peanut) at 1 year are at high risk of developing subsequent asthma, whereas those with these skin conditions but not sensitized are not at such risk.
Asthma, Author Interviews, JAMA, Orthopedics, Pediatrics / 14.11.2017

MedicalResearch.com Interview with: “Asthma” by Michael Havens is licensed under CC BY 2.0Teresa To, PhD Biostatistics, Design and Analysis Scientific Director The Hospital for Sick Children Dalla Lana School of Public Health, University of Toronto Institute for Clinical Evaluative Sciences Toronto, Ontario, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: We studied asthma prescription drug use in Ontario children aged 2 to 18 years with physician diagnosed asthma between 2003 and 2014. We found that:
  1. Currently in Ontario, nearly 50% of children with asthma did not fill a prescription for an inhaled corticosteroid during the study period, despite these medications being considered the gold-standard for asthma management.
  2. Our findings did not show clinically important association between inhaled corticosteroids and fracture among children with asthma.
  3. However, systemic corticosteroids (oral or injection) are associated with higher fracture risk in children with asthma (17% higher risk).
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