Knowing about pollen forecasts might help you understand how much pollen will be released in your area and when....
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.
(more…)
Response: Asthma is a chronic, progressive disease driven in part by underlying inflammation and requires long-term control of symptoms. Over time, this chronic inflammation can lead to a decline in lung function.
The Phase 3 open-label extension trial evaluated long-term safety and efficacy of Dupixent treatment in adults and adolescents with moderate-to-severe asthma who had previously participated in a controlled Dupixent clinical trial, including three pivotal trials that lasted between 24 and 52 weeks. With more than 2,200 patients enrolled, the Phase 3 LIBERTY ASTHMA TRAVERSE open-label extension trial is the largest of a biologic medicine ever conducted in asthma.
Dupixent is a biologic therapy that works differently from existing therapies that treat asthma. Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials have shown that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key drivers of the type 2 inflammation that plays a major role in asthma. It is the only biologic to demonstrate sustained improvements in lung function and asthma exacerbations across a broad patient population with type 2 inflammation. Dupixent is not an immunosuppressant.
(more…)
Olga 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.
(more…)
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. (more…)
Sean 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. (more…)
MedicalResearch.com Interview with: Bryce Hoffman, MD Allergy & Immunology Fellow National Jewish Health MedicalResearch.com: What is the background for this study? What are the...
Catarina 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. (more…)
Neil 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. (more…)
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. (more…)