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A pivotal Phase 3 trial of Dupixent (dupilumab) met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, according to press releases from 

 asthma patient population, defined as having elevated eosinophils (EOS) or elevated fractional exhaled nitric oxide (FeNO), Dupixent added to standard of care significantly reduced asthma attacks (exacerbations) and improved lung function, as early as two weeks after the first dose, compared to standard of care alone, according to the companies.

Dupixent is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

More than 90% of children in the trial had at least one concurrent type 2 inflammatory condition including atopic dermatitis and eosinophilic esophagitis, according to the press release. Safety results from the clinical trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with moderate-to-severe asthma.

“Children with uncontrolled moderate-to-severe asthma often struggle to breathe, largely

 because of their impaired lung function, and this can have a serious impact on their quality of life. It not only reduces their ability to participate in day-to-day activities, but can also take a huge emotional toll on the child and their family,” John C. Reed, M.D., Ph.D., global head of research and development at Sanofi said in a press release. “Dupixent is the only biologic shown in a controlled Phase 3 trial to improve lung function in children, which is generally consistent with results seen in the adolescent and adult trials. These positive data are especially encouraging for younger children who are struggling to manage their uncontrolled asthma.

"Children with moderate-to-severe asthma live with a heavy and unpredictable disease 

burden. Even while taking maximum treatments including inhaled corticosteroids, they suffer from multiple asthma attacks each year that may require hospitalization," said George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer of Regeneron in press release from Regeneron. "These impressive Phase 3 data in children with asthma show Dupixent significantly reduced annual severe asthma attacks and also improved lung function consistently across patients with markers of type 2 inflammation."

Dupixent has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying Dupixent in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric asthma (6 to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), chronic obstructive pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and food and environmental allergies (Phase 2). These potential uses are investigational, and the safety and efficacy of Dupixent in these conditions have not been evaluated by any regulatory authority.

Articles

Sanofi and Regeneron report positive Phase 3 results for Dupixent in children with moderate-to-severe asthma

Positive Results for Dupixent in Phase 3 Trial

We are looking forward to working with six new members of the 

François de Brantes is the senior vice president of episodes of care at Signify Health. He leads customer development of the Medicare Advantage, self-insured employer, and commercial payer markets. He has spent close to two decades working to transform the U.S. healthcare system by improving incentives for providers and consumers in order to encourage value-based decisions.

Prior to joining Signify Health, de Brantes served as vice president of Altarum, a national nonprofit. From 2006 to 2016, he was executive director of the Health Care Incentives Improvement Institute, a not-for-profit company that designed programs to motivate physicians and hospitals to improve the quality and affordability of healthcare delivery. The organization was responsible for the Bridges to Excellence® (BTE) and PROMETHEUS Payment® programs, which compensate and reward clinicians that focus on episodes of care and performance measures.

Prior to HCI3, François was chief operating officer of the eHealth Initiative (eHI). Early in his career he worked in General Electric’s corporate health care department.

De Brantes holds a master’s degree in economics and finance from the University of Paris IX-Dauphine and earned an MBA from the Tuck School of Business Administration at Dartmouth College. He lives in northwestern Connecticut.

Otis Brawley is the Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University in Baltimore and a globally recognized expert on cancer prevention and control and health disparities. Prior to Johns Hopkins, Brawley was chief medical and scientific officer and executive vice president of the American Cancer Society from 2007 to 2018. From 2001 to 2007, he was medical director of the Georgia Cancer for Excellence at Grady Memorial Hospital in Atlanta and deputy director for cancer control at the Winship Cancer Institute at Emory University, also in Atlanta.

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 and has been an outspoken critic of overscreening for medical conditions, especially cancer.

Brawley is member of the National Academy of Medicine and board certified in internal medicine and medical oncology. He has served on many committees and advisory panels.

Brawley earned his medical degree from the University of Chicago’s Pritzker School of Medicine and did his residency at University Hospitals of Cleveland, Case Western Reserve University before completing a fellowship at the National Cancer Institute.

Eric Hunter is the president and CEO fo CareOregon, a nonprofit health plan based in Portland, Oregon, that serves approximately 250,000 Medicaid and Medicare beneficiaries. Prior to CareOregon, Hunter was the chief operating officer for the Boston Medical Center Healthnet/Well Sense Health Plan in Boston. 

He has also held executive positions at Beacon Health Options (previously known as ValueOptions), Centene, Schaller Anderson, and the State of Oklahoma. 

Hunter earned his MBA from Northeastern University in Boston. He lives in Portland, Oregon.

Keely Macmillan is senior vice president of policy and solutions management at Archway Health, a value-based care solutions company headquartered in Boston. Macmillan leads a team of healthcare policy experts who evaluate two-sided risk models with a focus on technical and programmatic risk for the purposes of enhanced stop loss underwriting and helping participating providers succeed.

Prior to Archway Health, Macmillan was manager of government payment policy at Partners Healthcare in Boston where she managed public payer financial forecasting and led the analysis of performance-based payment models. Earlier in her career, she worked as a research analyst at Business Intelligence Advisors and at Yale University.

Macmillan earned a masters of science in public health from the Harvard T.H. Chan School of Public Health. She lives in Boston.

Ateev Mehrotra is an associate professor in the Department of Health Care Policy at Harvard Medical School and a hospitalist at Beth Israel Deaconess Medical Center in Boston. Much of Mehrotra’s research has focused on innovations in delivery such as telemedicine, retail clinics and e-visits have on quality, costs, and access to health care. He is also interested in the role of consumerism and whether price transparency and public reporting of quality can impact patient decision making. Another research interest is quality measurement including how natural language processing can be used to analyze the data in electronic health records to measure the quality of care.

Mehrotra has served on many committees and has been a RAND Corporation analyst since 2006.

Mehrotra earned his medical degree from University of California, San Francisco; a masters in public health from University of California, Berkeley; and masters of science degree from Harvard. He did a combined medicine-pediatrics residency at Massachusetts General Hospital and Boston Children’s Hospital. He lives in the Boston area.

Marc Samuels is the CEO of ADVI, a Washington, D.C.-based based advisory services firm whose strategies, policy analysis and data products help clients and organizations across the life sciences.

Prior to ADVI and its predecessor HillCo HEALTH, Samuels served both former Presidents George H.W. Bush and George W. Bush in federal and state government, respectively.

Samuels started his consulting career as a partner in the Health Policy Group, a firm founded by J. Michael Hudson, who served President George H.W. Bush in the Health Care Financing Administration (the predecessor to CMS) and President Ronald Reagan in the Treasury department and at the White House.

Samuels is policy counsel to the National Comprehensive Cancer Network and is a founding board member of the University of California, San Francisco, Roseman Institute’s BUILD Program

Samuels earned his law degree from the University of Texas Law School and his M.P.H. from Yale School of Medicine. He lives in Washington, D.C., and Austin, Texas.

Francois de Brantes, Otis Brawley, Eric C. Hunter, Keely Macmillan, Ateev Mehrotra, and Marc Samuels are joining the Managed Healthcare Executive® editorial advisory board.

Six New Members Added to MHE Editorial Advisory Board

Eat healthier foods, get more exercise, lose weight, take a statin if your LDL cholesterol level is elevated, and take an antihypertensive medication if you have high blood pressure blood — these are some of things that many Americans think about doing to lower their risk of having a heart attack.

The annual flu shot doesn’t make that list but it should. There’s little doubt that getting sick with the flu markedly increases the risk of having a heart attack. Researchers have been collecting evidence on the association between flu and cardiovascular mortality since the 1930s. And the heart attack risk from flu is especially high among people with diabetes and those with atherosclerotic cardiovascular disease (ASCVD). 

 for that was posted yesterday on the American College of Cardiology’s website, 

, MBBS, FACC, make a convincing case for flu shots being especially important this year for people with diabetes or ASCVD because of the COVID-19 pandemic and the possibility of infection by both viruses. They point to research showing that, in the past, about 1 in 3 individuals with diabetes do not get annual flu shot. They cite other studies showing that the ratio is roughly the same for people with ASCVD. 

“Given the suboptimal rates of annual influenza vaccination among DM (diabetes mellitus) and increased risk of coinfection with COVID-19 this influenza, vaccination against influenza among these high-risk individuals is critical until an effective vaccine against COVID-19 is made available and accessible to everyone,” say the trio. It is imperative, they say, to provide flu shots at alternative and nontraditional sites such as grocery stores and parks “to enhance equitable vaccination coverage while maintaining appropriate social distancing and infection control measures.”

Grandhi, Bhugra and Nasir cite a study published in 

 last month that used data from the Danish disease registry to show that flu shots reduced all-cause mortality, cardiovascular disease mortality, and heart attack and stroke mortality by about 15% among people with diabetes. That translates into number needed to treat of 1,333 to prevent one death. They also reference a 2015 meta-analysis of case-control studies that showed that flu vaccination was associated with a 29% decreased risk of heart attack.

Researchers have come up with various explanations for flu increasing heart attack risk. According to Grandhi, Bhugra and Nasir’s brief account, infection with a flu virus stirs up inflammation that has the effect of destabilizing atherosclerotic plaque so it is more likely to rupture, resulting in an occluded coronary artery.

Flu increases the risk of heart attack, especially among people with diabetes and atherosclerotic cardiovascular disease (ASCVD). COVID-19 and the possibility of co-infection makes getting vaccinated against the flu particularly important this year.  

Flu Shots Are More Important Than Ever for People with Diabetes, ASCVD

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a COVID-19 CareStart Antigen rapid test under 

, a New Jersey-based leader in the development and manufacturing of diagnostic tests for infectious diseases.

“This rapid antigen test may be the key to reopening schools and businesses,” says Young H. Choi, chairman and CEO, of Access Bio, in a release. “Within minutes of administering this inexpensive, U.S.-made test, a healthcare provider will better know whether or not a patient is infected.”

Access Bio has an 18-year track record of engineering and manufacturing superior-quality diagnostic kits for malaria, dengue, influenza and other infectious diseases, the release says.

The new rapid antigen test is fast and easy to administer in a point-of-care setting and can be conducted by nasopharyngeal (NP) swab by non-laboratory medical professionals. Access Bio’s rapid antigen test requires no additional equipment or special instrument for sample analyses, and results are visually read onsite in 10 minutes.

“This is a major breakthrough that has the potential to bring our daily lives back to normal,” says Reeve Benaron, founder, chairman and CEO of Intrivo Diagnostics, the exclusive distributor of the tests, in the release. “Because our rapid Antigen test does not require an instrument or machine, this means the test can be used anytime, anywhere. We’re confident that our test is a game-changer because it can be mass produced and is inexpensive enough to be widely used by healthcare professionals in schools, at large gatherings, and in office buildings.”

new COVID-19 antigen test is a lateral-flow immunochromatographic test for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of being infected with COVID-19 or exposed to COVID-19, the release says.

Clinical validations are showing results of 88.4% sensitivity and 100% specificity. CareStart is the the third test from Access Bio to receive EUA authorization from the FDA after its CareStart COVID-19 RT-PCR test and CareStartTM COVID-19 IgM/IgG antibody rapid test. Access Bio is now one of only two companies in the world to receive FDA EUA authorization for all available testing products on the market: RT-PCR, antibody, and antigen.

Each CareStartTM COVID-19 antigen test kit includes test devices, assay buffer, extraction vials and caps, specimen collection swabs, positive and negative control swabs, and instructions. Each kit can administer up to 20 antigen tests.

For more information about Access Bio and the CareStartTM COVID-19 Antigen test, visit: 

Emergency use authorization granted for CareStart point-of-care kit.


Author | MHE Staff

Articles

Positive Results for Dupixent in Phase 3 Trial

Six New Members Added to MHE Editorial Advisory Board

Flu Shots Are More Important Than Ever for People with Diabetes, ASCVD

FDA OK's 10-min COVID-19 Antigen Test