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Category Archives: Pharmacogenomics
J Mark FitzGerald,1 Eugene R Bleecker,2 Arnaud Bourdin,3 William W Busse,4 Gary T Ferguson,5 Laura Brooks,6 Peter Barker,6 Ubaldo J Martin6
1Centre for Heart and Lung Health, The Lung Centre Vancouver General Hospital, UBC Institute for Heart and Lung Health, Vancouver, BC, Canada; 2Divisions of Pharmacogenomics and Genetics, Genomics and Precision Medicine, University of Arizona College of Medicine, Tucson, AZ, United States; 3Department of Respiratory Diseases, Hpital Arnaud De Villeneuve, Montpellier, France; 4Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States; 5Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, United States; 6AstraZeneca, Gaithersburg, MD, United States
Correspondence: J Mark FitzGeraldThe Lung Centre, Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre, 2775 Laurel Street, Vancouver BC V5Z 1M9, CanadaTel +1604-875-4122Email firstname.lastname@example.org
Background: Benralizumab is an interleukin-5 receptor alphadirected cytolytic monoclonal antibody. Treatment with benralizumab significantly reduces exacerbations and improves lung function after 1 year for patients with severe, uncontrolled eosinophilic asthma.Objective: We explored whether benralizumab efficacy was sustained after an additional year of treatment while maintaining an acceptable safety profile.Methods: Data from the pivotal 48-week SIROCCO and 56-week CALIMA studies were integrated with data from the predefined 56-week adult phase of the BORA extension study to provide a 2-year integrated efficacy and safety analysis of benralizumab. BORA enrolled patients who had completed SIROCCO or CALIMA. Patients receiving benralizumab 30 mg subcutaneously, either every 4 weeks (Q4W) or every 8 weeks (Q8W; first three doses Q4W), were assessed. Efficacy was evaluated based on baseline blood eosinophil counts from the pivotal studies (300 and Results: Mean treatment exposures were 24.3 (Q4W, n=518) and 24.6 (Q8W, n=512) months. Exacerbation frequency reductions observed in SIROCCO/CALIMA were maintained; 50% of the patients had no exacerbations during the 2-year study period (crude exacerbation rate, Q8W: 0.56 exacerbations/year for patients with blood eosinophil counts 300 cells/L). Lung function improvements with benralizumab were maintained for 2 years, as represented by increases in mean prebronchodilator forced expiratory volume in 1 second from baseline of 0.343 L and 0.364 L with 1 and 2 years of benralizumab Q8W treatment, respectively, for patients with blood eosinophil counts 300 cells/L. Health-related quality of life improvements with benralizumab observed in the pivotal studies were also sustained. Adverse events and serious adverse event rates were similar between the BORA extension and SIROCCO/CALIMA periods, with no new or unexpected occurrence of adverse events.Conclusion: This benralizumab 2-year integrated analysis further supports long-term use of benralizumab for patients with severe, uncontrolled eosinophilic asthma.
Keywords: asthma, benralizumab, clinical features, eosinophilic inflammation, interleukin-5 receptor, safety
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.
More News26 Nov 2019 | 2:49 PM
Thiruvananthapuram, Nov 26 (UNI) National Institute of Speech and Hearing (NISH) has celebrated the 70th Constitution Day at its campus in Akkulam on Tuesday.
Sabarimala, Nov 26 (UNI) As many as 8 Ayyappa devotees were injured, two of them seriously, when a huge tree fell on them while they were trekking on the Chandranandan road near Marakkuttam, here in the wee hours on Tuesday.
Mangaluru, Nov 26 (UNI) ACP Squad in an operation arrested an Indian Army imposter Manjunath Reddy who was posing himself as Indian Army Junior Commissioned officer, at a his residence in Suratkal.
Mysuru, Nov 26 (UNI) Karnataka Chief Minister BS Yediyurappa on Tuesday expressed confident that BJP would sweep the upcoming 15 Assembly seats and that would put an end to all talks around mid-term polls in the state.
Udupi, Nov 26 (UNI) District Administration and police have warned devotees and tourists about fake website created by miscreants in the name of Sri Mookambika Temple at Kollur.
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Jipmer conducts JIPP 2019 - United News of India
Intermountain Healthcare to Gather Utility Data as SelectHealth Covers PGx Test for Certain Employees – GenomeWeb
NEW YORK Intermountain Healthcare next year will begin offering pharmacogenetic testing to a subset of its employees and their beneficiaries as a covered benefit through SelectHealth.
The health insurance company serves more than 900,000 members in Utah and Idaho. As a subsidiary of the Salt Lake City, Utah-based Intermountain Healthcare, SelectHealth also provides health insurance to the healthcare system's 45,000 employees and their beneficiaries.
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Analysis on the World’s Bioinformatics Market 2017-2019 and Forecast to 2023 – Review of Challenges & Opportunities following the Adoption of…
DUBLIN, Nov. 21, 2019 /PRNewswire/ -- The "Bioinformatics: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering.
The scope of the study encompasses the global bioinformatics market based on geography, category, and application. It provides a detailed analysis of recent advances in omic technologies and examines their impact on the bioinformatics market.
It discusses the ways in which bioinformatics has been utilized by the pharma and biotech industries to streamline the research and development (R&D) process and improve efficiencies. It provides a detailed analysis of the leading countries, companies, and technologies that will drive the field forward.
The report includes:
The rapid growth in raw data generation and advances in IT software and infrastructure have enabled researchers to integrate disparate datasets in order to decipher complex biological processes and develop predictive models of disease, for the purposes of identifying and validating novel biomarkers and developing precision medicines.
Since scientists unraveled the blueprint of the human genome more than 10 years ago, they have been exploring new ways to utilize omic data to understand more complex diseases. Researchers are eager to analyze as many different types of data as possible to gain a better understanding of what is happening at the cellular and molecular levels. Service providers have developed new analytical tools and IT infrastructures to enable scientists to interrogate complex data sources and quickly and efficiently disseminate information for better decision-making to achieve this goal.
More recently, improvements in cloud computing capabilities, advances in data analysis software services and the growth of NGS technologies have helped to expand the evaluation of available datasets, allowing researchers to build systems biology models of various diseases.
Key Topics Covered
Chapter 1 Introduction
Chapter 2 Summary and Highlights
Chapter 3 Global Bioinformatics Market: Overview
Chapter 4 Bioinformatics: Data Generation and Data Management
Chapter 5 Bioinformatics: Data Analysis and Software
Chapter 6 Bioinformatics: Data Processing and Storage
Chapter 7 Bioinformatics: Sequencing Services and Platforms
Chapter 8 Bioinformatics: Sequencing Applications
Chapter 9 Bioinformatics Applications in Pharmaceutical R&D
Chapter 10 Market Trends and Analysis
Chapter 11 Company Profiles
For more information about this report visit https://www.researchandmarkets.com/r/ywqdiu
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Clover Health similar to many other Medicare Advantage (MA) players has its sights firmly set on the home.
But unlike its larger and older MA peers, the relatively smaller and newer Clover isnt held back by certain structural constraints. That ability to build a home-focused model from the ground up is a big part of Clovers future, Chief Scientific Officer Kumar Dharmarajan told Home Health Care News.
And the technology-enabled Clovers future is bright: Founded in 2013, San Francisco-based Clover has raised about $925 million since launching. Among its backers: Google parent company Alphabet Inc. (Nasdaq: GOOGL).
HHCN recently caught up with Clovers Dharmarajan to learn all about its in-home care ambitions, its approach to partnerships and evolution into a payer-provider hybrid.
Highlights from that conversation are below, edited for length and clarity.
Dharmarajan: If youre asking about specific bids and plan offerings, those vary by location. Clover doesnt just have one U.S. plan, in other words.
We have a number of different offerings where we engage with members in the home. One of those is our in-home care program, where we provide in-home primary care services for some of our most vulnerable members, people with multiple chronic conditions, frailty and advanced illness.
Many of these folks are frequently hospitalized and have limited life expectancies. For those members, we wanted to provide a technology-enabled house calls experience. House calls have been shown by CMS and some of its demos to be really important to those who have trouble accessing care, including those who are homebound.
Many of the Clover members in this program do have difficulty leaving the home.
We give them access to physicians, nurses, social workers people who will see them monthly if needed. Theyll spend an hour or so at a time with our members. Contrast that to getting 10 minutes with your doctor in the office.
We focus on very comprehensive, holistic care thats aligned with members values, preferences and prognosis. We provide a number of interventions that are on the cutting-edge side.
We do pharmacogenomics testings. We want to make sure members medication regimens are best-aligned with how their bodies metabolize drugs. A lot of folks are on 10, 15 medications.
In some of these cases, its like a witchs brew, right? We want to make sure the regimen our members are on promotes their health and doesnt cause side effects.
For some of our members, we also give them access to what we call the Clover button, which is an ability for them to contact their provider directly. They dont have to remember a phone number. They just press a button, then they could talk through that and speak with their medical team.
And we do a bunch of other things where we really integrate payer and provider. Clover is a technology-enabled health insurance company, but this in-home care practice, this house calls practice is wholly owned by Clover.
Clover the health plan has access to a lot of different streams of medical information that we provide to Clover the practice.
For example, we often know when a member of ours is hospitalized or heads to the ER. We can get real-time data feeds a lot of times from those institutions. We then feed that info to the medical practice so they know exactly when a person leaves. In turn, we can engage with those individuals in the home as soon as theyre discharged.
Were really excited about that partnership between plan and provider.
At this point, Clover does not provide skilled home health services and things that fall into that bucket. We do have social workers who see our members and help with financial challenges. We have nurses who are part of our team, experts who are well-trained in, for example, wound management.
Were not trying to be a home health agency, but we do have some of those skillsets naturally within the team. And we do partner with home health agencies to really advance the care of our members.
In general, home health is probably underutilized for a lot of frail elders. We look to use home health care wherever it could benefit a member.
Unfortunately, its not a coincidence that some of the sickest, most vulnerable patients are also the most vulnerable from a social perspective, whether thats in regard to finances, housing, food or language barriers. For us, addressing social determinants is just part and parcel of the practice.
Its not something that we see as a unique strategy or something new that we need to suddenly start doing.
Its certainly en vogue now to talk about addressing social determinants of health. We just think its always been very core to the model of, you know, improving care for homebound older adults.
Regardless of that, committing to a home-based strategy is something that Clover has been interested in doing and has been investing in for some time. Home-based care is very scalable compared to brick and mortar.
Its also clear to us that home-based care allows you to pick up on and address issues that you would never see in an office setting. You go into the home of an older adult, you see six different bottles of insulin, all of which are different. This literally just happened with one of our members, who was actually blind. She didnt know which [insulin] to take.
When you go into the home, you see that. You can see whats in the refrigerator. You can engage with family members. Theres an incredible amount of data.
With our in-home care program, weve seen reductions in [hospital] admission rates, reductions in ER visitation rates. Weve seen reduced medical expenses overall. And weve heard from a lot of members who are just positive and grateful for the program.
Many people have never had house calls before.
I dont think I can tell you our specific partners at this point. But generally, I think there are a few things that are very important to us.
One is responsiveness. If you have a home health need, being able to quickly make the referral and have a team get in there ASAP is so critical.
Also having bi-directional communication is important. Once the home health provider is in there working with our member, we want to hear from that provider if they see something theyre concerned with. Even if its just, The member doesnt look at good today.
Provider groups need to be collaborators and, in a sense, sensors. Home health providers might be in the home more frequently than we are, depending on a members needs.
We have spoken with some and have embarked on some pilots. We do recognize that non-skilled services are an important part of the overall picture.
Progress in genomic science has been astronomical over the past few years. In fact, the tipping point that validated the clinical significance of genetic/genomic testing is barely visible in the rearview mirror. As a result, stakeholders ranging from clinicians to regulatory agencies, to professional associations, to payers have begun championing the value that precision medicine delivers in terms of better diagnoses and more effective therapeutic interventions.
For example, in educational materials explaining incidence of dilated cardiomyopathy (DCM), the American Heart Association notes that a full third of DCM patients inherit the condition from their parents or other family members. Germline testing can identify patients with this genetic variant, leading clinicians to a faster diagnosis and earlier treatment. The Food and Drug Administration (FDA) has stated its commitment to approving targeted therapies based on genetic mutations as appropriate. Payers are beginning to issue reimbursement policies to cover the cost of genetic/genomic testing. United Healthcare, for instance, began covering pharmacogenomic panels for patients with anxiety and depression this October.
This leads us to the next great transformation necessitated by precision medicine: implementing the technology infrastructure to govern the ordering and resulting processes inherent to genomics, as well as finding ways to manage the great volumes of data generated by testing.
Precision medicine is already being pursued sporadically across many, if not most, healthcare organizations. Oncologists are likely to be ordering somatic tests to better profile patient tumors so targeted therapies can be delivered. Family practice, behavioral medicine and psychiatric departments are using pharmacogenomics to understand how well (or poorly) patients metabolize specific medications and which might trigger side effects or safety concerns. These insights allow them to prescribe the right treatment at the right dose the first time around instead of spending months on a trial-and-error approach.
Cardiovascular and neurology specialists (among others) order germline tests to help them diagnose, treat and gain new insights into many common conditions such as congestive heart failure, arrhythmias, aneurysms, epilepsy, nerve pain and dementia. Some health systems even order germline tests on all newborns so a full genetic profile is available which can be used throughout the individuals lifetime.
The value of the data being generated through these clinical pockets cannot be understated. It carries information that can be used across a multitude of care settings far into the future to help providers and specialists arrive at more accurate diagnoses faster, and identify the most effective treatment sooner. This, in turn, can help healthcare leaders move the needle to improve quality efforts and optimize revenue while reducing the risk associated with poor outcomes.
To realize full value, however, healthcare organizations must ensure genetic/genomic test results are readily available to clinicians at the point of care and in a vocabulary that makes them meaningful. Unfortunately, few health systems have invested in the IT resources that can make this possible. Currently, test results are ordered in a vacuum and results are often returned in a PDF that will be hard to access. In addition, the information is relayed in a nomenclature unfamiliar to clinicians, so they struggle to understand how to apply the results to specific patient circumstances.
Unless these concerns are addressed, healthcare will simply reenact a mistake made years ago with the advent of electronic health records: valuable data that can immediately and directly impact care will be locked in a silo, unavailable during clinical decision-making.
As the industry heads into 2020, it must make plans and take action to get ahead of this looming problem. Healthcare IT professionals must be brought to the table to help organizations strategize about their precision medicine initiatives. The key to success with this new standard of care is recognition that data generated by genetic/genomic tests can be used endlessly across the enterprise and over the long term as patient conditions change. Organizations must seek out platforms that will consume genomic test results as discrete data and integrate it with patient-specific clinical information. Likewise, the platforms must be made available within existing workflows, so clinicians can leverage it during decision making and can interrogate the data as patient conditions change and genomic science delivers new insights.
Picture: Feodora Chiosea, Getty Images
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IT will be key to precision medicine's success in 2020 - MedCity News