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Vaxart Announces Publication of a Peer-reviewed Journal Article Showing the Potential Clinical and Economic Value of a Norovirus Vaccine -…

January 27th, 2021 9:53 am

SOUTH SAN FRANCISCO, Calif., Jan. 27, 2021 (GLOBE NEWSWIRE) -- Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, including a Phase 2 ready norovirus program, announcedtoday health care economic findings published in the American Journal of Preventative Medicine. Computational modeling simulating norovirus infection and transmission in a community setting showed that a potential norovirus vaccine can avert symptomatic cases and result in cost savings. The study found, among other things, that vaccination against the norovirus can reduce the economic burden of the virus and is cost effective even if priced at $500 per course when vaccinating children under 5 and older adults, a much higher value than previously estimated. The manuscript titled, Potential Clinical and Economic Value of Norovirus Vaccination in the Community Setting can be accessed here.

This study highlights the fact that norovirus is highly contagious and can lead to missed school and work, with productivity losses that can add up, said Bruce Y. Lee, MD, MBA, senior author of the study, Professor of Health Policy and Management at the City University of New York (CUNY), and executive director of the Public Health Informatics, Computational, and Operations Research (PHICOR). The preschool-age population can be particularly vulnerable due to heavy social mixing leading to greater spread of the virus, and the older adult population can be susceptible to more severe disease and subsequently experience high rates of outpatient visits and hospitalizations.

The PHICOR team developed a computational simulation model of different segments of the US population and the spread of norovirus to better understand the value of vaccinating children <5 and adults 65 years old against norovirus. The model simulated the spread of norovirus, subsequent clinical outcomes (e.g., symptoms, hospitalization, death) and associated costs (e.g., direct medical, productivity loss), as well as vaccination.

Key Findings:

These important findings confirm our view of the significant potential clinical and economic benefit of a norovirus vaccine, saidAndrei Floroiu, chief executive officer ofVaxart. The significantly higher cost levels from this analysis increase meaningfully our view of the value creation potential of our oral tablet norovirus vaccine. We are very excited to advance our norovirus program with the three clinical trials we expect to start in 2021 and look forward to confirming the efficacy and tolerability profile suggested by the very encouraging data from our previous Phase 1 studies.

Norovirus is the leading cause of acute viral gastroenteritis in all age groups in the United States. However, there are no approved vaccines for noroviruses. Each year, on average, norovirus causes 19 to 21 million cases of acute gastroenteritis and leads to 56,000 to 71,000 hospitalizations and 570 to 800 deaths, mostly among young children and older adults.

Vaxart, Inc. supported the PHICORs research team.

About PHICOR

Since 2007, PHICORs team of scientists and medical, public health, and communication experts have been researching and developing systems and computational approaches, methods (e.g., artificial intelligence (AI), machine learning, data science), models, and tools to help a wide range of decision makers address various health and public health issues. PHICOR helps local, state, and federal governments respond toinfectiousdiseasethreats, ranging from the flu to Ebola to Zika to the current COVID-19 pandemic. For example, during the 2009 H1N1 flu pandemic, the PHICOR team was embedded in the U.S. Department of Health and Human Services (HHS) to help with the national response. This included working with the Department of Homeland Security (DHS) and the Centers forDiseaseControl and Prevention (CDC).

AboutVaxart

Vaxartis a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform.Vaxartinvestigational vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury.Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxarts first immuno-oncology indication.Vaxarthas filed broad domestic and international patents covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxarts strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as should, believe, could, potential, will, expected, plan and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to the potential clinical and economic value of a norovirus vaccine in a community setting; Vaxarts ability to develop and commercialize its vaccine candidates and preclinical or clinical results and trial data; Vaxarts expectations with respect to the advantages it believes its oral vaccine platform can offer over injectable alternatives; and Vaxarts expectations with respect to the effectiveness of its products or product candidates.Vaxartmay not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements thatVaxartmakes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials or preclinical studies, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial and preclinical study data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxarts product candidates may not be approved by the FDA or non-U.S.regulatory authorities; that, even if approved by the FDA or non-U.S.regulatory authorities, Vaxarts product candidates may not achieve broad market acceptance; that aVaxartcollaborator may not attain development and commercial milestones; thatVaxartor its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxarts or its partners control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; thatVaxartmay not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxarts capital resources may be inadequate; Vaxarts ability to obtain sufficient capital to fund its operations on terms acceptable toVaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the Risk Factors sections of Vaxarts Quarterly and Annual Reports filed with theSEC.Vaxartdoes not assume any obligation to update any forward-looking statements, except as required by law.

References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vaxart is not responsible for the contents of third-party websites.

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Clinical trial to evaluate whether topical medication can prevent common skin cancer – Brown University

January 27th, 2021 9:53 am

PROVIDENCE, R.I. [Brown University] Dr. MartinA.Weinstock, a professor of dermatology and epidemiology at Brown University, will lead a six-year clinical trial to evaluate the effectiveness of a topical medication as a way to prevent the most common type of cancer in the United States.

Backed by a $34 million award from the U.S. Department of Veterans Affairs Cooperative Studies Program, the study will investigate the potential of imiquimod, a topical medication with minimal side effects, as a preventive measure against basal cell carcinoma. Weinstock who is the chief of dermatology research for the V.A. Providence Healthcare System will lead the trial with co-chair Dr. Robert Dellavalle, chief of dermatology for the V.A. Eastern Colorado Health Care System and a University of Colorado School of Medicine professor.

Basal cell carcinoma usually occurs on the face and requires surgery to avoid serious complications. An effective preventive medication could help many patients avoid or at least postpone the risks of surgery, and decrease the need for medical visits and their resulting costs, Weinstock said.

These lesions are typically treated with what I call a cut and wait approach, he said, noting that skin damage and scarring are undesirable side effects. Unfortunately, we dont have anything better right now.

More than 1,600 participants, including U.S. military veterans at high risk for basal cell carcinoma, will be recruited from 17 V.A. medical centers for the trial. They will apply the cream to their faces daily for up to 12 weeks and be followed actively for three years to see if their skin cancer risk is reduced, with an additional year of passive follow-up. In addition to evaluating effectiveness of the treatment, researchers will collect genetic material from some participants to determine factors that may indicate greater risk reduction and better tolerance of imiquimod therapy. This will help target therapy to those who will benefit from it the most.

Weinstock said that developing ways to actively prevent basal and squamous cell carcinoma has been a goal since he joined the Brown faculty in 1988. He has been involved with two other national studies directed at skin cancer therapies one of these clinical trials found that topical application of a cream containing 5-fluorouracil 5% reduced the risk of squamous cell carcinoma by 75% for a year.

Theres good reason to believe that well see in this upcoming trial that imiquimod has similar preventative effects on BCC, Weinstock said. And if that turns out to be the case, he said, it would fundamentally transform our approach to the disease we need to proactively prevent this cancer that afflicts millions each year."

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Health experts strongly suggest keeping up with preventative screenings during COVID-19 pandemic – KHOU.com

January 27th, 2021 9:53 am

We can all agree that a trip to the doctors office is no fun but doctors said putting off primary care is not an option.

HOUSTON The COVID-19 pandemic has pushed health priorities for many people to the forefront of their lives while other things have been placed on the back burner.

However, healthcare experts warn preventative checkups shouldnt be one of them.

We can all agree that a trip to the doctors office is no fun but doctors said putting off primary care is not an option.

We clearly saw during the peak of the pandemic in the summertime, we had people delaying care and having worse outcomes than they should have had because they put off the emergent evaluation of symptoms, Dr. James McDeavitt, dean of clinical affairs at Baylor College of Medicine said.

McDeavitt said ignoring health screenings can put you at risk.

When we look at the death rate for this past year unfortunately I think were going to see a death rate that exceeds COVID-19. Were going to see a higher rate of heart disease deaths and cancer deaths, and deaths from pulmonary disease, deaths from stroke because of care thats already been delayed, McDeavitt said.

In addition, UTHealth associate professor and pediatrician, Dr. Sandy McKay, said its not just adults. McKay said when it comes to children theres been a significant drop in vaccinations across the country.

Seeing as much as a 40% decline since COVID which is huge because these are vaccine-preventable illnesses that now children could be potentially be exposed to, McKay said.

She said regular checkups and care will help kids stay healthy during the pandemic.

We do not need to add something like measles or pertussis outbreak in a school which is going to add that much more layer of complexity to dealing with the pandemic, McKay said.

While most physicians have appointment availability both health experts encourage folks to take advantage of telemedicine if theyre concerned about visiting a doctors office. Their main goal is for you to stay on top of your health.

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Editorial: Vaccines can be the game-winning shot – The Reporter

January 27th, 2021 9:53 am

The state Department of Health announcement Tuesday that all Pennsylvania residents 65 years and older are eligible for the COVID-19 vaccine is good news in this ongoing battle against a pandemic that has claimed more than 400,000 lives in the U.S. in the past 10 months.

But expanding the eligibility doesnt get the preventative medicine in peoples arms. As long as a majority remain unvaccinated, the virus will continue spreading -- at an even faster rate with mutations that are taking hold.

The lags in getting vaccinated are for the most part due to supply and demand. In a state like Pennsylvania where 2.27 million people are over 65, there are just not enough doses. So far Pennsylvania has received only about 900,000 doses, according to the state Department of Health.

While that news is frustrating, there is encouragement that supplies will be replenished as manufacturing ramps up as additions from drugmakers AstraZeneca and Johnson & Johnson are expected to get FDA review and enter the pipeline in coming weeks.

And it is inevitable that states and counties will get better at the distribution and availability of vaccine, as well as boosting the signup capability. Right now, systems are crashing and people are waiting hours just to get access to websites to register for appointments.

However, what is even more troubling as thousands wait for the chance to be vaccinated is the reluctance among those who can get the vaccine and the skepticism being spun by naysayers.

In Berks County, Phil Salamone, public information officer of the Berks County EMS COVID-19 Joint Task Force and director of operations for Lower Alsace Ambulance, estimated there are 300 to 400 total workers in the ambulance crews in Berks and about a third of them "simply aren't interested in obtaining the vaccine."

Some of the reasons for refusing the vaccine might be that younger people don't believe getting COVID will do them much harm, while other people have heard of side effects that are simply rumors and have no basis in science; those who had COVID believe they are immune anyway, and some people simply bristle at what they consider to be a herd mentality.

"The message needs to be that if we're going to get through this pandemic we need to vaccinate as many people as possible. We wouldn't recommend something if the benefit didn't outweigh the risk," Dr. Robert J. Tomsho told The Reading Eagle. Tomsho is medical director of the emergency medicine institute, Lehigh Valley Health Network, and oversees training for ambulance crews.

The Moderna and Pfizer vaccines are essentially 100 percent effective against serious disease, Dr. Paul Offit, the director of the Vaccine Education Center at Childrens Hospital of Philadelphia, told David Leonhardt for The New York Times "The Morning" newsletter. Its ridiculously encouraging.

These vaccines are among the best vaccines ever created, with effectiveness rates of about 95 percent after two doses, Leonhardt wrote. If there is an example of a vaccine in widespread clinical use that has this selective effect prevents disease but not infection I cant think of one! Dr. Paul Sax of Harvard has written in The New England Journal of Medicine, dismissing speculation that getting a vaccine won't stop the spread.

"The risks for vaccinated people are still not zero, because almost nothing in the real world is zero risk. A tiny percentage of people may have allergic reactions. But the evidence so far suggests that the vaccines are akin to a cure," Leonhardt wrote.

Concerns are reported to be even more widespread among low-income and people of color, even though those populations have suffered the most cases and deaths. Officials in Montgomery County addressed those concerns head-on Thursday night in a town hall with Black church leaders encouraging their communitiues to participate and air their concerns.

The lack of supply, lack of an orderly and well-communicated system of distribution, and misinformation about vaccine safety have all contributed to diminishing the initial excitement that followed the approval of vaccines. The value, however, is as important as ever.

A few decades ago, the nation underwent a rollout of another vaccine that successfully eradicated polio, and then more vaccines for measles, mumps and rubella all of them having dramatic effect on public health and saving thousands of lives. This rollout needs to proceed with the hopeful enthusiasm that accompanied those vaccines. Efficiency and communication should be easier, not harder, in this age of technology and internet sophistication.

This vaccine remains our best chance to tame the pandemic and restore normalcy. This is our best shot; we need to take it.

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Roseville native named Family Physician of the Year – C&G Newspapers

January 27th, 2021 9:53 am

Dr. Kathy Rollinger recently was named the 2020 Family Physician of the Year by the Michigan Association of Osteopathic Physicians.

Photo provided by Kathy Rollinger

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ROSEVILLE Dr. Kathy Rollinger has been practicing medicine in southeast Michigan for her entire career and has saved and changed untold lives during that time.

Recently, her service was honored by the Michigan Association of Osteopathic Physicians, which named her the 2020 Family Physician of the Year.

Its very humbling to be recognized by the peers within your organization and for promoting family medicine in the area where you grew up and were raised, she remarked.

A Roseville native, Rollinger has spent her career helping residents on the east side.

I was raised in Roseville and went through Roseville schools and lived there for more than 30 years. My practice is in St. Clair Shores, and I live in Clinton Township. Basically, after medical school, you have to do a residency in what area youre interested in, and I became affiliated with both St. Johns (Hospital) and Beaumont (of Grosse Pointe) and went into family medicine. This is everything from delivering babies to individuals who are in their later years.

Rollinger said she loves working in family medicine and wishes more doctors would go into it since it offers more complete help to patients and requires a fuller knowledge of medicine on the part of the physician.

Family medicine is a specialty with a whole person approach to medicine, she explained. As an osteopathic family physician, our philosophy is to regard your body as an integrated whole. During medical school, we receive additional training in the musculoskeletal system. After completing medical school, and receiving your DO or MD degree, an additional three years of supervised training is required in family medicine. This training covers general medicine and specialty areas including preventative health care. I have been fortunate to incorporate low risk obstetrics, delivering babies and pediatrics into my family medicine practice.

She had to be nominated by her colleagues for the award.

You are nominated by fellow colleagues within the profession, and then a committee would vote on it, said Rollinger. I won a different award last year from them, the Distinguished Service Award. A few of my colleagues within the Michigan Association of Osteopathic Physicians were familiar with my work, and I think one of them nominated me.

Unbeknownst to Rollinger at the time, it was a former Michigan State University classmate of hers who nominated her for the award: Dr. Steve Swetech.

I have watched my classmate evolve into an exemplary osteopathic family physician, Swetech wrote in his nomination letter. She is the prime example of a hard-working successful female physician who even delivers babies! She is a pillar of her community and a champion for women in the medical profession.

Rollinger said being a doctor can be a double-edged sword, providing untold challenges but also being the most fulfilling thing she could imagine.

I think one of the most challenging aspects of family medicine is trying to provide comprehensive care in a real efficient manner, she said. I also work with family medicine residents, so I am helping teach them, and that is challenging, but the hardest parts are the time constraints because you want to give people the best care but only have so much time. I enjoy taking care of individuals and families the best. Getting to take care of babies I deliver and then continuing to take care of that family as they grow up is incredibly rewarding.

Rollinger also received the Michigan Osteopathic Associations Women of Excellence Award for 2020, which she said was nearly as much of an honor.

I think female physicians have continued to excel in the profession, and I am appreciative to work for a major hospital, Beaumont, and feel very supported by them, she said.

Rollinger added that being a family doctor allows her to be often both the first and last line of defense as people fight for their health.

There could be more awareness in the full spectrum in what family practitioners can provide to families, she said. I feel well trained in pediatrics, geriatrics and general medicine and so forth, and I certainly value my consultants in the specialty areas, but I think there is a special value of having a family doctor who knows everything about you and sees the whole picture.

Swetech said he could think of no other colleague more deserving for recognition than Rollinger.

She is a credit to her family, her schools and to society as a whole, wrote Swetech in his nomination letter. I entreat you to give serious consideration to the warrior and champion of womens recognition in the medical profession. Susan B. Anthony would be proud of this trailblazing osteopathic family physician.

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7 Ways Technology is Changing and Improving Healthcare – TFOT – The Future of Things

January 27th, 2021 9:53 am

Technology is constantly changing the way we interact with the world. The healthcare industry, in particular, is continuously evolving in tandem with technology. Many of the things we now view as easily treatable were once death sentences. Consider the fact that simple antibiotics are less than 100 years old.

In most cases, technology changes the health industry for the better. Here are seven ways technology is changing and improving healthcare now.

One of the most notable developments in recent decades is the streamlining of service delivery through the implementation of technology. Twenty years ago, most medical practices were using paper files, charts, and fax machines. There was no centralized access for patient information, making service delivery between specialists and GPs a nightmare.

According to RevenueXL, the implementation of Electronic Health Record (EHR) technology has streamlined everything from scheduling to insurance claims to billing. The use of this technology reduces the risks of patients falling between the cracks while mitigating human error. According to John Hopkins Medicine, medical errors were deemed to be the third leading cause of death in the U.S. at the dawn of the millennium.

While it may seem secondary to some of the more notable healthcare innovations of the last few decades, these clerical tools help improve patient care, from experience to quality.

Another significant development in recent years is the surge in telemedicine. Accessibility to reliable internet and cloud-based technology has made it easier for patients to seek medical attention especially in rural areas.

The use of this particular technological development skyrocketed during 2020 when many government agencies advised switching to this type of practice. Like EHR systems, telemedicine also streamlines and improves service delivery.

Rather than commuting and waiting to see a doctor, often missing work and losing income in the process, patients can seek assistance from anywhere. This access has tremendous benefits, especially for certain socioeconomic groups or people living in rural areas.

The discussion surrounding vaccine development is at the forefront of everyones minds. Much of the controversy surrounding the COVID-19 vaccine stems from the fact that mRNA vaccines have never been utilized to such a scale before.

While the use of mRNA vaccines was first put forth by Hungarian scientist Katalin Karik during the 1990s, the idea was well ahead of its time. Ironically, the innovation thats now at the global pandemics frontlines ended up being a career killer for Karik.

After the SARS outbreak in the early 2000s, mRNA vaccines were revisited as a possible combatant against epidemic outbreaks. While the process is yet to be refined, and COVID-19 is still a top priority, many scientists believe that the last decades developments will help them develop singular vaccines for various infectious diseases. Furthermore, these developments make production significantly faster.

Were still in the primordial ooze when it comes to AR and VRs potential in our world. However, many healthcare institutions are already capitalizing on this exciting technology to train medical professionals. Surgeons, in particular, are benefiting from VR training opportunities to hone their skills. The introduction of this technology has already marked a 230% improvement in performance over traditional training methods.

Augmented reality is being used similarly, mitigating the need for live patients or medical cadavers on which to train. The result? Better healthcare providers with fewer resources.

3D printed organs arent quite ready yet. However, bioengineered bladders have been effectively 3D printed and used successfully for several years. The challenge is that organ transplant demand for bladders is low, and the other organs are considerably more complex.

As of 2019, the team at Rensselaer Polytechnic Institute have successfully printed skin with blood vessels. This development, though not yet in clinical trials, could revolutionize wound treatment.

Technology has also improved diagnostics and preventative medicine by providing tools for self-led health tracking.

Wearable technology, such as the FitBit and Apple Watch, capture useful biometrics that could someday be used to assist with healthcare. Imagine walking into the doctors office and scanning your fitness tracker to share your resting heart rate, sleep patterns, etc.

Another area of self-led health tracking and diagnostics comes in the form of genetic sequencing. Services like 23andMe are giving customers insights into their genetic health backgrounds, highlighting potential issues well before they develop.

Finally, the internet and AI have made medical forecasting more accurate and attainable. Data from internet searches can help predict where outbreaks will occur. Applications are now available that allow patients experiencing certain illnesses to self-report and improve tracking, as weve seen with COVID-19.

With technology developing at an exponential rate, its exhilarating to watch how the world of healthcare unfolds in response.

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The Secret Ingredient That Can Make Your Cold and Flu Season Way Better – Yahoo Lifestyle

January 27th, 2021 9:53 am

We're all looking for the magic bullet to cure or prevent a cold or the flu. Herbs and medicine like echinacea and elderberries are often hyped as ways to keep from getting sick, especially in the winter. But do they work? While they certainly don't replace a flu shot, studies have shown that they can be beneficial at protecting against the common flu and cold. While elderberries have been used in traditional medicine for years, modern science gives us some clues as to why.

"They are rich in flavonoids quercetin and anthocyanidins, which are rich in antioxidants that protect your cells from damaging free radicals," explains Serena Poon, CN, CHC, CHN, chef, nutritionist, Reiki master, and founder of the Culinary Alchemy program. "Quercetin have properties that can protect against viruses, inflammation, and carcinogens. Anthocyanidins, a kind of plant pigment, are known for their anti-inflammatory benefits."

Poon also notes that studies have linked elderberries specifically to reducing the upper respiratory symptoms from cold and flu as well as reducing cold duration and severity. Poon recommends elderberries as preventative medicine, citing them as a low-risk way to protect yourself. It is important to note, however, that no studies have been done on elderberries and COVID-19, and elderberries do not replace CDC-endorsed measures like wearing a mask or social distancing.

While there are lots of good reasons to consider adding elderberry to your diet, you are going to be hard-pressed to find them for sale in the produce section. Raw elderberries are toxic, so that's actually a good thing. Instead, you'll find elderberries in different supplements and syrup. Poon recommends syrups as an easy way to get elderberry benefits but cautions that not all syrups and pills are created equal.

"It is really important to do your research on any supplement, including elderberry syrups or capsules," she says. When shopping either online or at your local health store, Poon has some tips for what to look out for: products that are certified organic, with transparent outsourcing practices, and that have third-party testing or certifications. She also recommends looking for supplements free from animal products, gluten, soy, and dairy.

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While that may sound like a lot to look out for, Poon notes that it's fairly easy to find high-quality elderberry syrups online. But if you want something now, there are also other immune-boosting foods you can find at your local grocery store. Poon recommends zinc and vitamin C during cold and flu season, which should be in any drugstore vitamin aisle. Taken alone or with elderberry supplements, these vitamins and minerals can provide a much-needed wellness boost during a time of the year when we're all worried about catching colds and the flu.

Take a look at some elderberry and immune-boosting supplements below.

Nature's Way Original Sambucus Elderberry Syrup ($20)

BioSchwartz Sambucus Elderberry Capsules With Zinc & Vitamin C ($10)

MaryRuth Organics Organic Liquid Elderberry ($20)

Garden of Life Mykind Organics Elderberry Gummy ($25)

Nature's Way Black Elderberry Capsules ($8)

Zarbee's Naturals Elderberry Immune Support Gummies ($17)

Gaia Herbs Black Elderberry Syrup ($20)

Sports Research Elderberry Capsules With Zinc & Vitamin C ($20)

Nature's Bounty Elderberry Gummies ($11)

Sambucol Black Elderberry Syrup ($13)

NOW Foods Elderberry ($8)

Next up: 9 Simple Things You Can Do Now to Boost Your Immune System

This article originally appeared on The Thirty

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My Turn: Our system of health care failed during the pandemic – Concord Monitor

January 27th, 2021 9:53 am

The pandemic has highlighted some serious flaws in the U.S. health care system. Mislabeled as a free market system, Americans have spent more money on combating the pandemic and received fewer benefits per dollar than any other nation.

Our health care system has slowly been taking us to the proverbial cleaners, but the pandemic has put us in the fast lane.

Primary care is secondary to for-profit health insurance: The whole point of insurance is to provide funds in the event of an emergency or life-altering occurrence. Health insurance was and still is designed to cover the cost of catastrophic health care. This is the inherent problem of basing the nations health care on a system designed to only cover catastrophes: It was never intended for routine care.

Health maintenance, such as routine visits to a primary care provider, is a secondary issue to health insurance companies. Primary care appointments will cost you an extra copay, which may or may not be a part of your deductible. As a result of these extra costs, Americans tend to see their primary care providers less frequently than citizens of other industrialized countries. If you have no insurance, many practices will not even schedule an appointment.

One of the reasons that Americans are particularly vulnerable to the ravages of coronavirus is the high number of people with health risk factors such as obesity, diabetes, and hypertension. All of these risk factors are reduced with routine check-ups with primary care providers.

But costs alone are not the only reason Americans have fewer preventive visits. The lack of availability of primary care providers is also a byproduct of for-profit health care. Insurance companies reimburse (pay) primary care providers less than they pay specialists. More U.S. medical school graduates become specialists in order to pay off their education costs in a timely manner. This also explains why many U.S. primary care providers are either nurse practitioners, physician assistants, or a graduate from a non-U.S. medical school.

Pandemics require planning and prevention: The U.S. was warned of the coronavirus pandemic as early as December 2019. While it is true that China was slow in announcing details that would have helped to slow the spread of the disease, we cant control what happens in China, but we could have taken precautions here at home, precautions that never materialized.

Sure, politics and a presidential denial were major factors in the devastating impact the virus had in the U.S., but the CDC and other public health agencies could have had more visibility earlier in the process to organize the preventative measures necessary to lessen the early impact of the virus. Given how poorly equipped our health care system is in preventing illness and the high number of people with health risk factors, this was a crucial oversight.

You cant fight an invading army with militias: We have some of the most advanced medical teams and technologies in the world, but without a centralized, coordinating health care system, much of this advantage is wasted. The for-profit, free market approach to health care is based upon the principle of competition and fragmentation. When a strong, unified and swiftly moving invasion force like the coronavirus hits our shores, we have no coordinated system to combat it.

Our fragmented system against a powerful and fast-moving pandemic is akin to fighting an army with amateur militias. This problem was compounded by the president, who saw no need to take the necessary precautions recommended by the CDC and his security advisers. Closing the border to China except for 40,000 people cannot be considered a serious prevention, as verified by history.

The fragmented system can be subjected to a considerable amount of mixed messaging. One of the reasons that President Trump was able to politicize the virus and the U.S. response was the lack of a central medical voice giving us the facts. Dr. Fauci and to a lesser extent, Dr. Birx symbolized the central response to the virus, but without a system in place to direct the messaging to health care providers and facilities, much of that information was delayed or subverted.

There were other people with medical degrees who espoused unproven contrary messages that confused the public and led to unnecessary medical delays and death. Without a central system in place, this type of problem can recur and in even greater numbers.

Vaccination distribution problems: The U.S. had planned to vaccinate 20 million people by the end of December, but only 2.8 million actually received the vaccine. Unsurprisingly, our free market health care system played a major role in this discrepancy because it was never designed to treat the country as a whole.

Without a national system in place, pharmaceutical companies were doing their best to get their product to 50 different states each with several vaccine distributors. We came up with an organizational plan about which groups should receive the vaccines and in which order, but with a myriad of competing health care systems, there was no way to ensure that the vaccines reached the proper providers.

At the current rate of distribution, the U.S. is projected to reach herd immunity in October 2023.

The problem of tying health insurance to employment: You cant claim that the U.S. has a free-market system of health care if individual consumers (thats all of us) dont pick the product, but our employers do. We wouldnt tolerate it if our employers determined which grocery stores we could shop in, so why do we want our employers determining our health insurance plans and the doctors associated with those plans? Even if our employers offer a choice of plans, they, not we, get do decide which options are available.

Many people fear socialized medicine, where other people direct our health care, but that is exactly what we have now. How ironic that the social medicine fear mongers rave against public options where the individual members of the public pick their doctors and their health plans.

Heres the problem: Before the pandemic, 10% of Americans had no health care coverage, and an estimated 30-40% of Americans were said to have inadequate health care coverage with high deductibles.

During the pandemic, many thousands of small businesses have closed and millions lost their insurance with their jobs. Now, many more people are without health care during the pandemic when they need it the most.

The future of American health care: How much weve learned from the pandemic depends upon where we go from here.

The private health insurance and pharmaceutical industries are each spending hundreds of millions of dollars in advertising and political funding to convince us that they should be the only option for health care. This effort will continue despite having the pandemic expose the inherit problems with our for-profit, fractionated, healthcare system.

There is no ideal health care system, but the health care system we have now is arguably the least perfect system possible due to its high costs and inefficiencies. We need an affordable, universal, easily accessible system under minimal political influence that can coordinate care in times of national medical emergencies such as a pandemic. This includes the need for basic health insurance that is independent of ones employment.

Our current Medicare system is an example often cited that comes close to meeting those needs listed above. Expanding that system would be costly and cause an increase in taxes to support it which would be more than offset by not having to pay higher premiums. We would be able to eliminate other government programs that are more expensive (Medicaid, CHIP).

But that is only one possible solution for replacing the present system which costs more money and more paperwork. In other health care systems, Americans would actually see an increase in their disposable income and fewer medical bills. We would also see a faster and better coordinated response to future pandemics.

There may be other options to consider as well, but those options might require recreating a whole new system of care.

Most importantly, whatever option we choose, a universal health care system would address the need for preventive care which would save Americans sick days, hospitalizations, paperwork, time and money. It would also make us better prepared to weather or even prevent the next pandemic.

(Dr. James Fieseher lives in Dover.)

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My Turn: Our system of health care failed during the pandemic - Concord Monitor

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Challenges to Weight Loss in the Immigrant LatinX Community – MedicalResearch.com

January 27th, 2021 9:53 am

MedicalResearch.com Interview with:Raveena CharaLoma Linda UniversityLoma Linda, CA

MedicalResearch.com: What is the background for this study?

Response: In a country struggling with an epidemic of obesity, Hispanics are one of the fastest growing population groups in the U.S. and have the highest prevalence of obesity. They are also least likely to enroll in weight reduction programs, complete them, and successfully lose weight (though reasons for this remain elusive).

Obesity- a leading predisposing factor for many chronic diseases is a complex biophysical phenomenon shaped by many factors, including a persons social environment, health and culture. Culture permeates many aspects of ones life including how a person views weight and behaviors associated with eating and physical activity. Indeed, for many values and norms about what is culturally acceptable and views on body weight vary culturally and affect their decisions about weight and weight loss. This too is the case within the Hispanic population in the US. Given the rising human and financial impact of obesity, preventing and reducing obesity, diabetes and other weight related medical conditions is a growing priority, especially for low income Hispanics.

MedicalResearch.com: What are the main findings?

Response: The purpose of our study was to explore socio-cultural influences on weight and the barriers to weight loss in monolingual and bi-lingual immigrant Hispanics. In order to do so we explored perceived social environmental influences, community perceptions, religious and cultural influences, support systems related to weight, and weight loss. This study helped reveal two important themes associated with obesity in the Hispanic community; sociocultural themes and structural themes.

Sociocultural Themes:

Structural Themes:

MedicalResearch.com: What should readers take away from your report?

Response: Preventing and reducing obesity is an urgent and complex matter that is affected by individuals social environment. Our female Latino immigrant participants spoke of the critical role socio-cultural factors play, such as the lack of family and community support due to the central nature of food in social life, cultural views about weight and beauty (a little thick is beautiful), and mental health (eating as coping) due to the many pressures they experienced. They also spoke of structural factors, such as the effect of immigration to the U.S., affecting their ability to freely walk/meet for exercise (less walking, more driving), more access to fast food because of its ever-growing presence in their communities, pricing, and lack of easily accessible and affordable produce alternatives. CHWs [also Latino immigrants] who conducted these interviews also shared that, more recently, the political climate in the U.S. has created fear, impacting social engagement and resulted in a reluctance by those interested in lifestyle changes to engage in programing, outdoor activities as well as social events.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: For weight loss to become successful in our immigrant Latino populations, programs must address both structural as well as sociocultural factors in line with the Social Determinants of Health Framework. Lifestyle changes rather than weight -loss alone should be targeted. Programs need to find practical and culturally informed ways to help participants begin what will need to become a lifelong quest to alter the way they eat and live. Cultural expectations that are maladaptive to healthy changes include: food having a central role in social life, cultural views of weight and obesity (weight gain is not seen as a problem), eating well is a sign of wealth/success, and when eating together everyone is expected to eat the same thing. Understanding these cultural beliefs and expectations is critical to any lifestyle programing. Finally, programing needs to occur in a safe political environment and take participants stress and mental health needs into account.

MedicalResearch.com: Is there anything else you would like to add?

Response: While a complex challenge for everyone, achieving weight loss is even more complex among immigrant Latinos than it is in non-Hispanic whites. Even if participants want to engage in healthy behaviors, the social determinants in their lives often negatively impact their health and ability to attend programming. Efforts to reduce health disparities need to take these issues into consideration and seek creative culturally aligned and acceptable solutions. When working in communities with multiple challenges, especially communities affected by the current political and immigrant policies, any program promoting lifestyle changes should take into consideration safety, meeting places and social determinants of health and cultural beliefs.

No Disclosures

Citations:

APHA 2020 abstract: Sociocultural factors affecting obesity in immigrant hispanic womenAbstract: 2036.0:Sociocultural factors affecting obesity in immigrant hispanic womenRaveena Chara1, Maud Joachim-Clestin, MD, DrPH, CHES1, Guljinder Chera, MD(IP)2, Carmen Soret, MPH(c)1, Marisol Lara, B.S., MPH1and Susanne Montgomery, PhD, MPH, MS1, (1)Loma Linda University, Loma Linda, CA, (2)American University of Antigua, Coolidge, Antigua and Barbuda

https://apha.confex.com/apha/2020/meetingapp.cgi/Session/60436

Kaplan, M. S., Huguet, N., Newsom, J. T., & Mcfarland, B. H. (2004). The association between length of residence and obesity among Hispanic immigrants. American Journal of Preventative Medicine. Retrieved July 25, 2019, fromhttps://www.sciencedirect.com/science/article/pii/S07 49379704001825#aep-bibliography id12.

-Hruby, A., & Hu, F. B. (2015). The Epidemiology of Obesity: A Big Picture. NCBI. Retrieved July 25, 2019, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4859313/.

-Kaufman, L., & Karpati, A. (2007). Understanding the sociocultural roots of childhood obesity: Food practices among Latino families of Bushwick, Brooklyn. Social Science and Medicine. Retrieved July 25, 2019, from https://www.sciencedirect.com/science/article/pii/S027795 3607000640.

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The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

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Coronavirus (Covid-19) Impact On Global Preventative Healthcare Technologies and Services Market 2021: Quest Diagnostics Incorporated, Medtronic,…

January 27th, 2021 9:53 am

A new informative report on the Global Preventative Healthcare Technologies and Services Market has recently been published by DBMR and added to its widespread database which will help to make better strategic decisions in the businesses. such as Company Overview, Financial Overview, Product Portfolio, Business Strategies, and Recent Developments. Moreover, it offers summarized data on various business perspectives such as global market shares, drivers, restraints, recent innovative trends, and challenges in front of the global Preventative Healthcare Technologies and Services market. Preventative Healthcare Technologies and Services industry report firstly introduced the Preventative Healthcare Technologies and Services basics: Definitions, Classifications, Applications and Market Overview; product specifications; manufacturing processes; cost structures, raw materials and so on. Then it analyzed the worlds main region Preventative Healthcare Technologies and Services market conditions, including the product Price, Profit, Capacity, Production, Supply, forecast (2021 -2027), demand, market growth rate etc.

Preventative healthcare technologies and services market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to growing at a CAGR of 11.10% in the above-mentioned forecast period. The growing awareness amongst the physicians and patients regarding the benefits of advance technology as well as services will help in boosting the growth of the market.

Download Free Exclusive Sample (350 Pages PDF) Report: To Know the Impact of COVID-19 on this Industry @ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-preventative-healthcare-technologies-and-services-market&AS

The major players who are leading the market throughout the globe are:

COVID 19 scenario analysis:

Preventative Healthcare Technologies and Services Market Segmentation:

By Type (Early Detection and Screening Technologies, Chronic Disease Management Technologies, Vaccines, Advanced Technologies to Reduce Errors)

By Application (Hospitals, Clinics, Others)

MAJOR TOC OF THE REPORT:-

Get Complete Latest TOC of This Report @ https://www.databridgemarketresearch.com/toc/?dbmr=global-preventative-healthcare-technologies-and-services-market&AS

Competitive Landscape and Preventative Healthcare Technologies and Services Market Share Analysis

Preventative healthcare technologies and services market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to preventative healthcare technologies and services market.

The major players covered in the preventative healthcare technologies and services market report are Myriad Genetics, Inc., Quest Diagnostics Incorporated., Medtronic, Abbott., Merck & Co., Inc., GlaxoSmithKline plc., Omnicell, Inc., McKesson Corporation, Pfizer Inc., Dilon Technologies, Inc., OMRON Healthcare Europe B.V., among other domestic and global players. Market share data is available for Global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Significant Highlights of the Report:

Global Preventative Healthcare Technologies and Services Market Scope and Market Size

Based on type, preventative healthcare technologies and services market is segmented into early detection and screening technologies, chronic disease management technologies, vaccines, and advanced technologies to reduce errors. Early detection and screening technologies have been further segmented into automated screening, personalized medicine, and other advanced screening technologies. Chronic disease management technologies have been further segmented into blood pressure monitors, asthma monitors, cardiovascular monitors, and glucose monitors.

Make An Enquiry and Ask For Customized Report@ https://www.databridgemarketresearch.com/inquire-before-buying/?dbmr=global-preventative-healthcare-technologies-and-services-market&AS

Preventative Healthcare Technologies and Services Market Country Level Analysis

About Data Bridge Market Research Private Ltd:

Data Bridge Market ResearchPvt Ltdis a multinational management consulting firm with offices in India and Canada. As an innovative and neoteric market analysis and advisory company with unmatched durability level and advanced approaches. We are committed to uncover the best consumer prospects and to foster useful knowledge for your company to succeed in the market.

Data Bridge Market Research is a result of sheer wisdom and practice that was conceived and built-in Pune in the year 2015. The company came into existence from the healthcare department with far fewer employees intending to cover the whole market while providing the best class analysis. Later, the company widened its departments, as well as expands their reach by opening a new office in Gurugram location in the year 2018, where a team of highly qualified personnel joins hands for the growth of the company. Even in the tough times of COVID-19 where the Virus slowed down everything around the world, the dedicated Team of Data Bridge Market Research worked round the clock to provide quality and support to our client base, which also tells about the excellence in our sleeve.

Data Bridge Market Research has over 500 analysts working in different industries. We have catered more than 40% of the fortune 500 companies globally and have a network of more than 5000+ clientele around the globe.

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CES 2021: Some Of The Coolest Gadgets We Saw – TWICE – Twice

January 27th, 2021 9:53 am

Mini- and MicroLED big screen TVs. Autonomous driving car tech. Gaming PCs and accessories. Smart appliances and smart home. Robots. 5G. COVID COVID COVID health/wellness-related products. Work-from-home office tech. These are all products and technologies we expected to see represented at CES 2021. But hidden in the crevices of virtual CES 2021, we found some cool gadgets that you may have missed.

ActiveLook EVAD-1 Smart SunglassesSometimes checking your workout progress on a smart watch or smartphone can be distracting or, if youre running on a road, dangerous. These smart sunglasses, paired with a smartphone, projects your performance data such as beats per minute, pace, speed and distance on the inside of the lenses thanks to a heads-up display powered by Microleds ActiveLook technology. (May, apx. $500)

AirPop Active+ with Halo Sensor Smart Face MaskHow long will we have to wear face masks? Even if by some miracle we become a maskless society sooner than we think, wearing this AirPop may still be a good idea. Its makers say AirPop Active+ is the worlds first smart air wearable to helps wearers gain a deeper understanding of their respiratory health, capturing and correlating breathing-related data with real-time air quality and location data. The Halo sensor, working in tandem with the AirPop app, provides an overview of the wearers breathing behavior, breathing cycles, biometric data, pollutants the mask has blocked, and when to replace their masks snap-in filter, which blocks >99% of particles. (Q1, $149.99)

ArchelisFX ExoskeletonHopefully well all be back in Las Vegas for CES in January 2022. Hopefully, well be able to buy one of these admittedly ungainly a nerdy exoskeleton suit so we can stay on our feet on the show floor for 16 hours a day without requiring several post-show chiropractic appointments. Initially designed for factory workers and doctors, the archelisFX enables wearers to walk and bend their knees freely and to sit or rest anywhere while technically standing. The suit is all mechanical no power needed. Archelis execs say the company is working on a consumer version, hopefully one we can wear under our clothes a year from now at the LVCC. (Q1, $1,000)

Fluo Labs Fl Allergy ManagementYou may not be able to expose your body to bright light to kill COVID, but you can shine this Fl device up your nostils for 10 seconds each up to two times a day to help alleviate seasonal allergies and hay fever symptoms. But this is not merely digital snake oil. The Fl nose light is actually a medical technology called photobiomodulation. Fluo Labs is a medical device company and its been researching this allergy alleviation solution for 15 years. A recent clinical test yielded a 31% improvement over baseline, better than antihistamines or other drugs, with no known side effects. Two more trials are planned as the company works toward FDA to make Fl a welcome and potentially revolutionary over-the-counter solutions for seasonal allergy congestion, itching, runny nose and sneezing. (Q4, <$100)

GoSun Flow Solar Powered Water Purifier & PumpIn what could be the perfect accessory for Naked & Afraid contestants or wannabees or anyone spending long stretches in the wilderness the GoSun Flow Solar Powered Water Purifier & Pump not only knocks out 99.99% of pathogens from water, but also functions as a portable handwashing station or even a hot shower. Small enough to fit into a backpack, the Flow is a solar-powered pump that can sucks fresh water from an unclean source then automatically filters one liter per minute through a three-stage filter cartridge, good for cleansing 1,000 liters. One full Flow solar charge can filter 100 gallons of water, and the its battery power bank recharges in the sun. A faucet can be clamped to a collapsible basin, and a 12-volt submersible heater provides washing/bathing-appropriate warm or hot water. (March, $349)

Kohler Stillness Infinity Experience Freestanding BathtubIf even the virtual version of CES has unnerved and exhausted you, why not take a nice hot bath after all, the best preventative medicine is to just plain relax. Using the Kohler app, users can remotely fill this 48 x 48 x 23.64-inch deep, 111.5-gallon tub, and set the desired water temperature. The water overflows into the Hinoki wood infinity pool mote surrounding the tub to create a soothing sound, which, combined with light, fog, and essential oils aromas, creates what Kohler calls an immersive journey of the senses designed to relax the mind, soothe the body and renew the spirit. Of course, the Stillness Infinity price might tighten you up all over again. (October, $15,998)

MaskFone Face Mask/EarbudsHow many times have your earbuds been accidentally jerked out of your ears when taking off your surgical face mask? MaskFone solves this problem attached to it are a pair of Bluetooth noise canceling earbuds. The mask itself is made of a soft but durable machine washable twill fabric that easily forms to all face shapes, and includes a nose wire. Its disposable, interchangeable N95 filters provide 95% virus protection. To keep the mask from muffling your voice during phone calls, MaskFone includes voice projection powered by the Hubble Connect app for clear audio. Amazon Alexa is included to provide voice control over your music play and your other smart devices, and you get 12 hours of single-charge listening time. (February, $49.99)

Milo The Action CommunicatorThis re-imagined family radio enables people within 2,000 feet of each other in outdoor environment to stay in contact, extended out by the MiloNet mesh network when your group spreads out. But instead of hand-held push-to-talk operation, the palm-sized Milo The Action Communicator works more like a Star Trek communication badge. Clipped to a pocket, handlebars, or an armband, the IP67 water- and dust-proof Milo, available in signature red, white and black, provides full-duplex group voice conversations on what the company describes as an all-day battery. For more precise communication, you can plug in or pair Bluetooth earphones to them. Milo is developing a longer-range mode that, in testing, has exceeded more than a mile; new features will be delivered via regular software updates. (February, $169)

Olive Pro True Wireless Buds/Hearing AidsMany true wireless buds with ambient sound modes purport to boost your hearing yeah, not really. These stylish Olive Pros actually do theyve been classified as an FDA class II medical device. But wait, theres more: the buds AI engine identifies and amplifies voices while simultaneously detecting and eliminating background noise, plus theres a 10-band EQ in the app as well. You get 7 hours of single-charge listening and two more full charges from the battery case, and theyre IPX7 water resistant. (Q1, $299)

Samsung Slim Over The Range MicrowaveGot an oven hood? Got a microwave? Got a kitchen space problem? Samsung lets you combine two capacious cooking installations with its smart Slim Over-the-Range (OTR) Microwave. Designed to simply replace your under-cabinet hood, the Slim OTR Microwave is equipped with a power ventilation system capable of vacuuming an impressive 550 cubic foot per minute of steam, fumes, odors, and, we hope not, smoke. The microwave also packs power, with an industry best 1100-watt output, which speeds your food prep. (price, availability not yet announced)

SelfSafe ID BraceletNot that you want to think about it, but what will happen to you in case you lose your ID, wallet, home or consciousness? This password-protected USB emergency identification waterproof bracelet stores all your important personal information, including medical, financial, insurance, travel documents, personal identification and more. The bracelets secure, yet quickly accessible design allows you to be prepared for lifes unexpected emergencies. ($29.95)

Targus UV-C LED Disinfection LightWhile there are several frequently touched spots in your home prone to retain harmful microscopic lifeforms, arguably the most touched surface after your face is your PC keyboard. As long as its motion sensor senses no activity within or directly outside its active cleaning area, this Targus UV-C LED Disinfection Light switches for five minutes every hour to disinfect surfaces it bathes, eliminating potential disease-bearing pathogens. Literally, just set it and forget it to remain healthy. (Spring, $299)

Tata Band/Tat Pad Child Car Seat AlarmHow anyone can leave then forget a child locked in hot car beggars the imagination. But for the potentially fatal absent-minded theres two Tata baby car seat safety alarm solutions: a band that wraps around one of the seatbelt straps, or a pad your child sits on. Both get paired via Bluetooth to a smartphone, then is programmed to emit a series of increasingly frantic alarms when that connection is broken, i.e., when your smartphone is out of Tata range of your car and child. After three minutes the phone emits a sound notification. A minute later, the parents phone gets a call. Three minutes after that, the Tata calls and leaves messages for emergency contacts. The company is looking for international partners. ($59 each)

See also: TWICE, Residential Systems & TechRadar Pro Announce Picks Awards Winners For CES 2021

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CES 2021: Some Of The Coolest Gadgets We Saw - TWICE - Twice

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COVID-19 and healthcare workers: a rapid systematic review into risks and preventive measures – DocWire News

January 27th, 2021 9:53 am

This article was originally published here

BMJ Open. 2021 Jan 20;11(1):e042270. doi: 10.1136/bmjopen-2020-042270.

ABSTRACT

OBJECTIVE: The COVID-19 pandemic is demanding for occupational medicine and for public health. As healthcare workers (HCWs) fight impacts of SARS-CoV-2 on front lines, we must create safe work environments through comprehensive risk assessments, evaluation and effective implementation of counter-measures. We ask: What does current literature report on health risks at workplaces regarding COVID-19? and What do current studies report on the effectiveness of enacted preventative recommendations?

METHODS: As a snapshot of early HCW research, on 26 April 2020, we conducted a rapid systematic literature search in three databases (PubMed, Web of Science and PsycInfo) for COVID-19-related health outcomes and preventive measures in healthcare-associated workplaces.

RESULTS: 27 studies were identified as relevant for exploring the risk of infection, 11 studies evaluated preventive measures. The studies described that SARS-CoV-2 impacts significantly on HCWs health and well-being, not only through infections (n=6), but also from a mental health perspective (n=16). 4 studies reported indirect risks such as skin injuries, one study described headaches to result from the use of personal protective equipment. Few studies provided information on the effectiveness of prevention strategies. Overall, most studies on health risks as well as on the effectiveness of preventive measures were of a moderate-to-low quality; this was mainly due to limitations in study design, imprecise exposure and outcome assessments.

CONCLUSIONS: Due to widespread exposure of HCW to SARS-CoV-2, workplaces in healthcare must be as safe as possible. Information from HCW can provide valuable insights into how infections spread, into direct and indirect health effects and into how effectively counter-measures mitigate adverse health outcomes. However, available research disallows to judge which counter-measure(s) of a current mix should be prioritised for HCW. To arrive at evidence-based cost-effective prevention strategies, more well-conceived studies on the effectiveness of counter-measures are needed.

PMID:33472783 | DOI:10.1136/bmjopen-2020-042270

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COVID-19 and healthcare workers: a rapid systematic review into risks and preventive measures - DocWire News

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The Benefits of Strength Training: Why Cardio Isn’t Enough – LIVESTRONG.COM

January 27th, 2021 9:53 am

You know strength training is key to building muscle, but how bad is it to skip?

Image Credit: LIVESTRONG.com Creative

How Bad Is It Really? sets the record straight on all the habits and behaviors youve heard might be unhealthy.

Official guidelines recommend doing muscle-strengthening activities at least two times per week. But only about a quarter of adults meet those requirements.

That's nearly half as many people who have a regular cardio workout, according to the Centers for Disease Control and Prevention.

"Some people don't know how to resistance train and are worried they might get injured, while others have an injury or condition that doesn't allow them to weight train to a full capacity," says Araceli De Leon, CPT, a certified personal trainer, kinesiologist and spokesperson for the American Council on Exercise.

"In addition, there is a misconception around weight training among some females, who think they might get too bulky or gain too much muscle," she says.

Another common barrier is "gym-timidation," a lack of knowledge about how to use weight-lifting equipment and the intimidation that can come with it. Women, in particular, reported lower comfort using gym facilities, including strength machines and free weights, according to a November 2020 study from Penn State University.

But hey, as long as you're exercising regularly, does skipping out on pumping iron actually matter that much? Is strength training mandatory?

Cardio bunnies, consider this your wake-up call.

Why Doing Cardio Alone Isn't Enough

Let's be clear: We're not knocking a heart-pumping aerobic workout, which is amazing for your health in so many ways. But if you don't also incorporate resistance work, your body will pay the price.

"Your muscles might atrophy you will lose muscle mass and endurance because you're not using your muscles as much," De Leon says. "Your ligaments and tendons can also weaken."

Skipping out on strengthening is also bad for your bones. "Weight training puts stress on your bones, which nudges bone-forming cells into action," De Leon says. "If you don't do resistance exercises, your bones may get weaker and lose some mineral content."

This is especially important for older adults primarily those who are postmenopausal, as the decline in estrogen levels leads to bone loss, increasing your risk of fractures.

In fact, resistance exercise alone or in combination with other forms of physical activity is the ideal training for improving bone mass in postmenopausal women, middle-aged men and older adults, according to a December 2018 review in Endocrinology and Metabolism.

Finally, if weight loss is your goal, you won't torch nearly as many calories without resistance training, says A. Brion Gardner, MD, an orthopedic surgeon specializing in sports medicine at the Centers for Advanced Orthopaedics in Manassas, Virginia.

"When you do a 30-minute cardio session, you are burning calories for that 30 minutes," he says. "But a 30-minute weight-lifting session will have you burning calories for the rest of the day, an effect known as excess post-exercise oxygen consumption."

That's because strength training, by causing microscopic stress to your muscles, triggers your body to enter a recovery state. That muscle recovery uses calories for energy.

Plus, the more lean muscle you have, the more you'll increase your basal metabolic rate, the number of calories you burn each day just to maintain normal biological function. Muscle is metabolically active, meaning it burns more calories at rest than body fat, he says.

The Benefits of Strength Training

Not convinced yet? "There are so many benefits to resistance training, even if you already have an aerobic program," De Leon says. "Because everything in the body is connected, having a solid muscular foundation is important in the way one's body moves, heals and interacts with other body systems."

Just check out all these major payoffs.

You'll Prevent Injury and Promote Healing

Increasing your strength training volume and intensity are associated with a reduced risk in sports injury risks, according to an August 2018 meta-analysis in the British Journal of Sports Medicine.

A 2017 report from the American College of Sports Medicine also shows that following a resistance-training program is associated with a lower incidence of stress fractures, falls and low-back injuries in people who are physically active.

And if you do get hurt? You'll bounce back more quickly and efficiently if you've been sculpting muscles.

"Resistance training strengthens your tendons and ligaments, which can help you recover from injuries, like a sprained ankle or dislocated shoulder," De Leon says. "It will also improve your balance and posture by strengthening the small stabilizers that keep you erect."

It Will Enhance Your Athletic Performance

Runners with a strength-training practice significantly improve their speed and endurance, according to a September 2019 study in the British Journal of Medicine. "Increased muscle fiber size and contractile strength lead to greater physical capacity," De Leon says.

She explains that her own resistance workouts have helped her become stronger in other pursuits. "I'm a long-distance runner, and targeting my leg, core and glute muscles helps me have longer, more successful runs," she says.

Her strength-training routine also allows her to be a more powerful rock climber, stabilizes her in yoga practice and prepares her for snowboarding days.

You May Reduce Your Risk of Disease

A November 2017 study in the Journal of the American Heart Association found that moderate strength training (between 100 to 145 minutes per week) is associated with a lower all-cause mortality risk in older women.

In fact, older adults age 65 and over who followed recommended guidelines to strength train at least twice per week had 46 percent lower odds of all-cause mortality than those who didn't, in a February 2016 study in Preventative Medicine.

But that's not all research shows that women who focus on strengthening their muscles reduce their risk of type 2 diabetes by 30 percent and cardiovascular disease by 17 percent compared with those who don't strength train, according to a January 2017 study in Medicine & Science in Sports & Exercise.

The bottom line: Combining strength training with aerobic exercise is linked to an even lower risk of type 2 diabetes, cardiovascular disease and early death than doing cardio alone.

It Can Help Boost Your Mood

According to a June 2018 meta-analysis in JAMA Psychiatry, resistance training reduces symptoms of mild to moderate depression.

"Resistance training regulates your blood flow and heart rate, which clears away brain fog and pumps you full of feel-good endorphins," De Leon says.

As you perform new feats of strength, your mental strength and confidence will also improve.

You'll Reduce Low-Back Pain

A small May 2020 study in BMC Sports Science, Medicine and Rehabilitation found that people with lower back pain experienced significantly less discomfort and saw improvements in pain-related disability when they followed a strength-training program. (A randomized clinical trial looking at this effect is currently underway.)

De Leon explains that strengthening your core via resistance work lends support to your lumbar spine (lower back), relieving pressure and pain. Bonus: The study participants also reported an increase in energy levels.

You Might Sleep Better at Night

Building muscle may even improve shuteye, according to a small May 2015 study in the Journal of Strength and Conditioning Research, in which people fell asleep faster and had fewer nighttime awakenings on days when they engaged in resistance training.

Which Kind of Strength Training Is Best?

There are many different ways to strength train, but the best modality for you depends on your abilities, goals and needs. Here's the 101.

"Although both machines and free weights, such as dumbbells and kettlebells, allow you to gain a similar amount of muscle size and strength, free weights require more core engagement and activate more muscle groups than a machine," De Leon says. Without the support of a machine to hold you in the proper position, your body is forced to work harder to maintain your posture.

"As a result, free weights are better for building muscle long term, compared to a machine that may only be targeting specific muscles," De Leon says.

Because machines provide more support, they can be a good bet for beginners who haven't yet honed their form. "A machine is also great to work on improving your form and range of motion after an injury," De Leon says.

"These [resistance bands] are cheap and portable," De Leon says. "Although they do increase muscle size and strength, in the long run, they will become less challenging." To make your strength workouts more challenging with resistance bands, you can add them to your dumbbells or kettlebells.

"Body-weight workouts use your own weight to provide resistance against gravity," De Leon says. The best part is that body-weight exercises don't require any special equipment, like weight machines, dumbbells or even resistance bands. You can do them anytime, anywhere, which is especially helpful if you're avoiding the gym during the COVID-19 pandemic.

"To build muscle using body-weight training, gradually increase the amount of reps or train until failure for example, by doing squats until you physically can't do any more," De Leon says. "You can also try a 'time under tension' workout, where you perform each movement very slowly so that it becomes more difficult."

So, How Bad Is It Really to Never Strength Train?

As long as you are still getting an aerobic workout, you're not doomed if you skip pumping iron. "There is no harm per se in not weight training," Dr. Gardner says.

But it's certainly not ideal. "Over time, it can lead to adverse health effects and the loss of fitness gains," De Leon says. "People with a strength-training practice have an overall greater quality of life."

Aim to strength train at least twice per week, and experiment with different types of resistance-training equipment to help you figure out what will help you reach your goals. Because the more you enjoy that activity, the higher the chances you'll stick to a routine.

Ultimately, you'll be better off if you quit resisting resistance training. Now drop and give us 20!

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The Benefits of Strength Training: Why Cardio Isn't Enough - LIVESTRONG.COM

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electroCore, Inc. Announces Scottish Health Technology Group Recommendation For Use of gammaCore in NHS Scotland Cluster Headache Patients -…

January 27th, 2021 9:53 am

ROCKAWAY, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- electroCore, Inc.(Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that Health Improvement Scotland (HIS) has published a Scottish Health Technology Group (SHTG) adaptation for NHS Scotland on the use of gammaCore for cluster headache. The SHTG publication is based on guidance produced in 2019 by the U.K. National Institute for Health and Care Excellence (NICE), which states that gammaCore, when used alongside standard of care, can reduce the frequency and intensity of cluster headache attacks, leading to significant quality of life benefits for people living with this condition and can save an average of 450 per patient in the first year of treatment through a reduction in acute rescue medication use, and with electroCore offering no-cost evaluations for all patients. The SHTG publication recommends that gammaCore should be available for a 3-month trial period for use in treating NHS Scotland patients suffering from cluster headache and the SHTG adaptation will now be disseminated across NHS Scotland health boards by HIS, to inform the use of gammaCore for cluster headache.

We are delighted by the recommendation from the Scottish Health Technology Group to consider the application of the medical technology guidance produced by NICE in 2019 to NHS Scotland, saidIain Strickland, electroCores VP of European Operations. We welcome the opportunity to provide our proven and established therapy to more patients in Scotland suffering from the debilitating condition of cluster headache. I would like to thank the Scottish experts who worked on this assessment and arrived at the conclusion that an equivalent recommendation to the one in effect in England and Wales was also needed in Scotland. The publication notes the devastating impact that cluster headaches can have on the lives of sufferers and the desperation that can result from ineffective treatment, so the further ratification of gammaCore as an effective treatment option is great to see.

The SHTG adaptation can be viewed at:

http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/topics_assessed/adaptation_01-21.aspx

About Scottish Health Technology Group

The Scottish Health Technologies Group (SHTG) is a national health technology assessment (HTA) agency. They provide evidence support and advice to NHS Scotland on the use of new and existing health technologies which are not medicines and which are likely to have significant implications for peoples care.

About electroCore, Inc.electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The companys current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit http://www.electrocore.com.

About gammaCoregammaCore(nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patients neck over the vagus nerve, gammaCore stimulates the nerves afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about anticipated government support provided by the HIS, SHTG, NHS and NICE; statements about electroCore's business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the Companys business prospects in Eastern Europe and other new markets and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCores business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore, the potential impact and effects of COVID-19 on the business of electroCore, electroCores results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at http://www.sec.gov.

Investors:Hans VitzthumLifeSci Advisors617-430-7578hans@lifesciadvisors.com

or

Media Contact:Jackie DorskyelectroCore973-290-0097jackie.dorsky@electrocore.com

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European Commission Approves AbbVie’s RINVOQ (Upadacitinib) for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis – PRNewswire

January 27th, 2021 9:52 am

NORTH CHICAGO, Ill., Jan. 25, 2021 /PRNewswire/ --AbbVie (NYSE: ABBV), today announced that the European Commission (EC) has approved RINVOQTM (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. RINVOQ is also indicated for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.1 The EC approval is supported by data from the three pivotal clinical trials SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1, demonstrating RINVOQ's efficacy across multiple measures of disease activity.* 4-6

"Psoriatic arthritis and ankylosing spondylitis have a significant impact on many aspects of life for those living with these conditions," saidTom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie. "We are proud to provide RINVOQ as a new treatment option to patients with PsA and a first-in-class treatment option to those living with AS. These approvals are important milestones in our commitment to develop a portfolio of solutions that advance standards of care for people living with rheumatic diseases."

"Psoriatic arthritis and ankylosing spondylitis are multi-faceted diseases that can cause severe pain, restricted mobility, and lasting structural damage," said Iain McInnes, Professor of Medicine and Versus Arthritis Professor of Rheumatology at University of Glasgow, UK. "In clinical trials, RINVOQ demonstrated improvements across multiple manifestations of these diseases. The approvals of RINVOQ for the treatment of PsA and AS offer physicians in the European Union an important new therapeutic option and for their patients a new opportunity to find meaningful relief from their debilitating symptoms."

In both Phase 3 clinical trials, SELECT-PsA 1 and SELECT-PsA 2, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo in adults with active PsA who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs, respectively.4,5RINVOQ also achieved non-inferiority to adalimumab# (40mg, every other week) for ACR 20 at week 12.4Patients receiving RINVOQ experienced greater improvements in physical function (as measured by HAQ-DI at week 12) and skin symptoms (as measured by PASI-75 at week 16), and a greater proportion achieved minimal disease activity (MDA) compared to those receiving placebo at week 24.4,5

RINVOQ also met the primary endpoint of Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 14 versus placebo in SELECT-AXIS 1, a Phase 2/3 study in adult patients with AS who were nave to biologic DMARDs and had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).6 Additionally,RINVOQ achieved statistical significance across several multiplicity adjusted key secondary endpoints versus placebo, including ASAS partial remission (PR) at week 14 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at week 14.6

Safety results from SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1 have been previously reported and were consistent with those observed in rheumatoid arthritis, with no new significant safety risks identified.3-6 Integrated safety data for SELECT-PsA 1 and SELECT-PsA 2 through week 24 show that Serious Adverse Events occurred in 4.1% of the patients in the RINVOQ 15 mg group compared to 3.7% in the adalimumab group and 2.7% in the placebo group.7,8 The most common adverse events reported with RINVOQ 15 mg were upper respiratory tract infection, nasopharyngitis, increased blood CPK, ALT increase and AST increase.3-5 In SELECT-AXIS 1, Serious Adverse Events were reported in 1% of the patients in both the RINVOQ 15 mg and placebo group. The most common adverse events reported with RINVOQ 15 mg included blood CPK increase, diarrhea, nasopharyngitis, headache and nausea.3,6

The Marketing Authorization means that RINVOQ is approved in all member states of the European Union, as well as Iceland, Liechtenstein and Norway. RINVOQ is already approved for the treatment ofadults with moderate to severe active rheumatoid arthritis.2

About Psoriatic Arthritis and Ankylosing Spondylitis

Psoriatic arthritis and Ankylosing spondylitis are debilitating diseases that can cause severe pain, restricted mobility and lasting structural damage.9-11 Despite treatment advances, many people with AS and PsA often do not achieve their treatment goals.12,13

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including skin and joints.14 In psoriatic arthritis, the immune system creates inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints.10,14

Ankylosing spondylitis is a chronic, inflammatory musculoskeletal disease primarily affecting the spine and characterized by debilitating symptoms of pain, limited mobility and structural damage.16

About SELECT-PsA 12,4

SELECT-PsA 1is a Phase 3, multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ compared to placebo and adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg, adalimumab 40 mg EOW or placebo at baseline. At week 24, placebo patients were switched to either RINVOQ 15 mg or RINVOQ 30 mg.

The primary endpoint was the percentage of subjects receiving RINVOQ 15 mg or RINVOQ 30 mg who achieved an ACR20 response at 12 weeks of treatment versus placebo. Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16 and proportion of patients achieving minimal disease activity (MDA) at week 24. These are not all of the secondary endpoints. The trial is ongoing and the long-term extension will provide data on the long-term safety, tolerability and efficacy of RINVOQ in patients who have completed the placebo-controlled period.

Top-line results from SELECT-PsA 1were previously announced in February 2020. More information on this trial can be found atwww.clinicaltrials.gov(NCT03104400).

About SELECT-PsA 22,5

SELECT-PsA 2is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one biologic (bDMARD). Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.

The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment. Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16, as well as proportion of patients achieving MDA at week 24. These are not all of the secondary endpoints. The trial is ongoing and the long-term extension will provide data on the long-term safety, tolerability and efficacy of RINVOQ in patients who have completed the placebo-controlled period.

Top-line results from SELECT-PsA 2were previously announced in October 2019. More information on this trial can be found atwww.clinicaltrials.gov(NCT03104374).

About SELECT-AXIS 12,6

SELECT-AXIS 1is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with activeankylosing spondylitis who are bDMARD-nave and had inadequate response to at least two NSAIDs or intolerance to/contraindication for NSAIDs.

Key ranked secondary endpoints included proportion of subjects achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 and ASAS partial remission (PR) at week 14, as well as change from baseline in Ankylosing Spondylitis Disease Activity Scores (ASDAS), MRI Spondyloarthritis Research Consortium ofCanada(SPARCC) score (spine) and Bath Ankylosing Spondylitis Functional Index (BASFI) at week 14. Period 2 is an open-label extension period to evaluate the long-term safety, tolerability and efficacy of RINVOQ in subjects who completed Period 1.

Results from SELECT-AXIS 1were previously announced in November 2019. More information on this trial can be found atwww.clinicaltrials.gov(NCT03178487).

About RINVOQ(upadacitinib)

Discovered and developed by AbbVie scientists,RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.3,17-27 InAugust 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. InDecember 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.17, 20-27

Important Safety Information about RINVOQ (upadacitinib)1

RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.

Use in combination with other potent immunosuppressants is not recommended.

Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis have been reported with upadacitinib. Prior to initiating upadacitinib, consider the risks and benefits of treatment in patients with chronic or recurrent infection or with a history of a serious or opportunistic infection, in patients who have been exposed to TB or have resided or travelled in areas of endemic TB or endemic mycoses, and in patients with underlying conditions that may predispose them to infection. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. As there is a higher incidence of infections in patients 65 years of age, caution should be used when treating this population.

Patients should be screened for TB before starting upadacitinib therapy. Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.

Viral reactivation, including cases of herpes zoster, were reported in clinical studies. Consider interruption of therapy if a patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.

The use of live, attenuated vaccines during, or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunization guidelines.

The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. The clinical data are currently limited and long-term studies are ongoing. Malignancies, including non-melanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy.Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Absolute neutrophil count <1000 cells/mm3, absolute lymphocyte count <500cells/mm3, or haemoglobin levels <8g/dL were reported in<1% of patients in clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with these haematological abnormalities observed during routine patient management.

RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.

Upadacitinib treatment was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo. If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.

Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient's risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation. If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.

The most commonly reported adverse drug reactions (ADRs) were upper respiratory tract infections, bronchitis, nausea, blood creatine phosphokinase (CPK) increased and cough. The most common serious adverse reactions were serious infections.

Psoriatic arthritis: Overall, the safety profile observed in patients with active psoriatic arthritis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. A higher incidence of acne and bronchitis was observed in patients treated with upadacitinib 15 mg (1.3% and 3.9%, respectively) compared to placebo (0.3% and 2.7%, respectively). A higher rate of serious infections (2.6 events per 100 patientyears and 1.3 events per 100 patientyears, respectively) and hepatic transaminase elevations (ALT elevations Grade 3 and higher rates 1.4% and 0.4%, respectively) was observed in patients treated with upadacitinib in combination with MTX therapy compared to patients treated with monotherapy. There was a higher rate of serious infections in patients 65 years of age, although data are limited.

Ankylosing spondylitis: Overall, the safety profile observed in patients with active ankylosing spondylitis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. No new safety findings were identified.

Please see the full SmPC for complete prescribing information atwww.EMA.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Rheumatology

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTubeand LinkedIn.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties, including the impact of the COVID-19 pandemic on AbbVie's operations, results and financial results, that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits of the Allergan acquisition, failure to promptly and effectively integrate Allergan's businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the Allergan acquisition, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission (SEC). AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

* Key domains include: Patient's global assessment of disease activity; Pain; Function; Inflammation# Superiority for RINVOQ 15 mg to adalimumab could not be demonstratedIn patients with 3% BSA psoriasis at baseline

References

SOURCE AbbVie

abbvie.com

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European Commission Approves AbbVie's RINVOQ (Upadacitinib) for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis - PRNewswire

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What’s best for arthritis: elliptical or treadmill? | News, Sports, Jobs – The Express – Lock Haven Express

January 27th, 2021 9:52 am

BY KEITH ROACH, M.D.

DEAR DR. ROACH: If I have the beginnings of arthritis of the knee, is an elliptical machine better to use than a treadmill? M.D.

ANSWER: If you had an inflammatory arthritis like rheumatoid arthritis, there are powerful medicines that can dramatically slow or stop progression of the disease. So Im going to assume you have osteoarthritis, which is by far the most common arthritis of the knee.

No treatment is known to stop the progression of osteoarthritis. But exercise is one of the most effective treatments to reduce pain and especially to increase function. This is counterintuitive to many people even many doctors are loath to prescribe exercise because for years osteoarthritis was considered a wear and tear injury of the joint. Research shows this not to be the case. Although joint injury can lead to development of osteoarthritis, regular exercise does not. Many studies have shown that a graded exercise program (starting slow and easy, and gradually building up) can lead to better function and endurance.

Unfortunately, many people with severe osteoarthritis have such pain that exercise seems impossible. People write to me that they just cant do any exercise, and indeed, it can get to the point where any movement is so painful that joint replacement becomes the only viable option. But for people with early arthritis, like you, and even moderate arthritis, exercise is a powerful tool.

Elliptical machines put less impact pressure on the joint and will be better tolerated by people with more-advanced arthritis. Pools provide the most support for your joints. However, you can do whatever exercise feels best to you. Both treadmills and elliptical machines are an investment (so is a gym membership, once the pandemic is under control), but brisk walking is cheap and effective.

DEAR DR. ROACH: In regard to your recent column on COVID-19 exposure, though it may seem logical to advise the person to avoid playing tennis that night with a contact of a COVID case, the person who was the contact was described as having not seen his son for at least one week before the diagnosis. In fact, the recommended look-back time for defining contact is 48 hours before the onset of symptoms or before a positive sample was collected in someone who is asymptomatic. According to the Centers for Disease Control and Prevention, a close contact is someone who was within 6 feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period starting from 2 days before illness onset (or, for asymptomatic patients, 2 days prior to test specimen collection) until the time the patient is isolated.

Stating that the father of the son needs to quarantine would lead to many more people quarantining than is currently recommended. Though that might truly be useful, current efforts are aimed at contacts of known cases whose exposure was within the period when the risk of transmission was most significant. M.K.

ANSWER: I appreciate Dr. M.K., who is a professor of medicine and an infectious disease specialist, for writing. I wrote my answer to be as cautious as possible, but Dr. M.K.s point is correct that the last exposure to the son was several days before the son developed symptoms and presumably several days before the son had the positive COVID test, though the submitted question implied the test was earlier than the symptoms. The father would not currently be recommended to quarantine by the CDCs guidelines. However, a person should consider their own risk of severe complications should they become infected when planning activities.

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UK-based Ampersand Health rolls out My Arthritis DTx – Mobihealth News

January 27th, 2021 9:51 am

Looking to the rheumatology space, UK-based digital health company Ampersand Healthis rolling out a new product called My Arthritis DTxto support patients with inflammatory arthropathies.

Patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis can use the tool to self-managetheir condition. It provides users with educational resources and courses, and can connect to their clinical team if their UK National Trust uses the tool. Patients can asynchronously communicatewith their care teams.

Patients using the tool can tap into cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness services. The tool also lets users track their arthritis over time, as well as monitortheir physical health, mental health and sleep.

HIMSS20 Digital

Currently, the product is in clinical trials. This marks Ampersand Health's second digital product. Its first product, My IBD Care, focuseson helping individuals with Crohn's disease or ulcerative colitis.

WHY IT MATTERS

Inflammatory arthropathies are very common. In fact, more than 54 million people in the U.S. have arthritis, according to the CDC.

The agency says that age increases the likelihood of the condition, as well as obesity. Patients can manage the condition through education programs, activities and losing weight, according to the agency.

THE LARGER TREND

Several digital health companies are working on products to support arthritis patients. In June, SidekickHealthpartnered with Pfizerto launch an appaimed at helping patients with diseases including rheumatoid arthritis manage their conditions from home. The deal is thought to be worth more than $8 million.

The interest in the space has long a history. In 2018,MyHealthTeams announced a deal to join forces with UCB to add a new spondyloarthritis social network. UCB has also worked with Garmin on a wellness program for rheumatoid arthritis patients.

Swedish startup Joint Academy raised $23 million in Series Bround of funding in September 2020 for its clinical evidence-based digital treatment for chronic joint pain, which connects patients with licensed physical therapists. Formerly calledArtho Therapeutics,its total funding raise comes to $34.2 million.

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UK-based Ampersand Health rolls out My Arthritis DTx - Mobihealth News

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[Full text] Adherence to Treatment in Patients with Rheumatoid Arthritis from Spai | PPA – Dove Medical Press

January 27th, 2021 9:51 am

Introduction

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by persistent synovitis, systemic inflammation and the presence of autoantibodies. Uncontrolled active RA causes joint damage, disability, decreased quality of life, and cardiovascular and other comorbidities.1 Current recommendations state that therapy with disease-modifying antirheumatic drugs (DMARDs) should be started as soon as the diagnosis of RA is confirmed.2

Adherence can be defined as the process by which patients take their medications as prescribed. This process includes initiation of the drug, implementation of the prescribed regimen and discontinuation of the drug.3 Lack of adherence contributes to an inadequate response or failure to treatment, worsening or disease relapse, and unnecessary treatment changes.4 It has been stated that compliance declines over time.5 This is important because a lack of adherence to pharmacologic therapy is a prevalent issue in the treatment of chronic diseases such as RA.

Adherence has not been widely examined for most rheumatic conditions.6 The ability of physicians to recognize nonadherence is poor, and interventions to improve adherence have had mixed results.7 Currently, a gold standard for the measurement of adherence is not available.7,8 The use of patient questionnaires, an indirect method to measure adherence, is an inexpensive and useful method due to its simplicity.7 A compliance questionnaire in Rheumatology (CQR) was developed to measure compliance to treatment and to identify factors that contribute to suboptimal adherence in patients suffering from RA, polymyalgia rheumatica and gout.9 This 19-item measure has been proven to be useful to predict compliance and identify barriers that interfere with it.9,10 Recently, the Korean and the Spanish versions of CQR, sCQR, for patients with RA have been validated.11,12 They showed high reliability with good testretest results and a high predictive value suggesting that they could be used as screening instruments. In addition, the use of sCQR could also help to identify reasons for nonadherence.12

Increased knowledge of the impact of therapeutic adherence of patients with RA, and identification of possible predictors of adherence will allow to develop strategies to promote adherence. The main objective of this work was to describe the prevalence of treatment adherence in patients with RA in Spain using the sCQR. Secondary objectives were to detect possible differences in adherence in patients receiving biologic DMARDs (bDMARDs) compared to conventional DMARDS (cDMARDs) and/or glucocorticoids, in patients receiving intravenous therapies compared to other routes of administration and in patients treated in Rheumatology specific day hospitals versus polyvalent day hospitals. Another secondary objective was to identify potential predictors of adherence.

We performed an observational, cross-sectional, multicenter study in outpatient clinics of Rheumatology Departments from 41 centers in Spain.

Patients were invited to participate in the study during a routine visit to the rheumatology outpatient departments. In case of agreement, the sCQR was completed by the patient in the waiting room before seeing the rheumatologist and deposited in a box. In no case, the rheumatologist had access to the answers. If respondents did not understand any specific question or had trouble reading it, it could be read aloud to them verbatim, in any case, this would induce patients to respond in a certain way. Demographic and disease data were collected during the visit. No diagnostic or therapeutic interventions other than those required by the routine practice were performed. Available data at the moment of the visit were obtained to ensure reflecting real-world practice with no interference.

Adult patients that fulfilled the 1987 American College of Rheumatology (ACR) criteria for RA or RA diagnosis given by a rheumatologist, attending routine visits, were recruited on a consecutive basis. They had to be treated with glucocorticoids, cDMARDs (methotrexate, leflunomide, sulfasalazine, antimalarials) and/or bDMARDs (infliximab, adalimumab, etanercept, certolizumab, golimumab, tocilizumab, rituximab, abatacept) for at least 3 months and give their informed consent in order to participate in the study. Patients had to have the ability to complete the questionnaire or have someone who could help them in its completion.

To calculate sample size, results obtained in the preliminary study of the transcultural adaptation of sCQR were considered, where a 78% adherence to treatment was established.12 Estimating a similar proportion of therapeutic adherence and having in mind that the prevalence of RA in Spanish population is 0.5%13 and Spanish population is 46,439,864 inhabitants, for an alpha error of 5% and an accuracy of 3% it was estimated that the necessary sample would be 730 patients. Assuming a loss percentage of 15%, a total population of 859 patients was determined to be necessary.

To achieve a representative sample, centers were selected across the Spanish geography according to population density and public health spending. Approximately 40 centers were estimated to be necessary. At least one region was randomly selected from each of the four groups, created according to stratification criteria, depending on population and health expenditure (supplementary Figure 1).

An effort was made to include as many regions and centers in the study. In each region, second- and third-level centers participated so that the sample was as representative as possible. The geographic variability of the recruited centers also contributed to guarantee this. The established minimum number of centers being selected in each group depended on the population of each of the groups.

The compliance questionnaire in rheumatology (CQR) is a 19-item questionnaire that encompasses various aspects of adherence (Box 1). Spanish validated version was used in this study. Items indicating greater adherence (questions 13, 57, 10 and 1318) were scored from 3 to 0 (3, strongly agree; 2, agree; 1, little agreement; 0, completely disagree). Items indicating poorer adherence (questions 4, 8, 9, 11, 12 and 19) were scored from 3 to 0 (0, strongly agree; 1, agree; 2, little agreement; 3, completely disagree). To adjust its weight, a coefficient was applied to each item, to generate a Z score (ZK): ZK = a + W1X1K + W2X2K + + W19X19K, where ZK is the discriminant Z score for patient K, a is a constant, Wi is the discriminant weight for item i and patient K. A cutoff point allowed classifying patients into those with satisfactory compliance or unsatisfactory compliance.12

Box 1 Compliance Questionnaire in Rheumatology

The following data were collected: demographic data (age, sex, study level, civil status and cohabitation), data related to RA (disease duration, number of drugs used to treat RA, auxiliary drugs were not considered, eg folic acid or vitamin D, glucocorticoids use and route of administration, cDMARD use and route of administration, bDMARD use and route of administration), hospital infrastructure (specific day hospital versus polyvalent).

The study was approved by Santiago-Lugo Ethics Committee (Registry Code: 2017/296 dated 29/05/2018). All the procedures were performed in accordance with the requirements for studies involving human participants and followed the principles stated in the Declaration of Helsinki. Both informed and written consent were sought from each participant using a consent form before enrollment in the study. Survey confidentiality and anonymity were assured to all enrolled participants.

A descriptive analysis of all of the variables included in the study was performed. To identify if there were differences depending on the treatment received (bDMARDs versus cDMARDs), its route of administration or the area of origin, Chi2 was used. Likewise, in order to identify adherence predictive factors, a univariate and multivariate linear regression study adjusted for significant variables and for age and sex variables was performed. Values of statistical significance were considered at p < 0.05. In the regression analysis, the categorical variables included were the number of medications the patient was taking, steroid use, use of cDMARDs, routes of administration of cDMARDs, use of bDMARDs, routes of administration of bDMARDs, health area, sex, level education, marital status and cohabitation. Continuous variables included in the regression analysis were the age and disease duration. For the statistical analysis, Stata version14.0 (Stata/MP14.0 for Windows; StataCorpLP, College Station, TX) was used.

A total of 859 patients contributed by 41 centers were selected and included in the study. All patients answered the questionnaire, 729 patients completed the 19 items and 130 skipped at least one of them. For analysis purposes, we considered patients who completed the 19 items. Baseline patient characteristics are shown in Table 1. A total of 418 patients (48.7%) were being treated with bDMARDs and 682 (79.3%) were receiving cDMARDs. Five hundred and sixty-five patients (65.8%) were receiving more than one drug for the treatment of RA (glucocorticoids, cDMARDs and/or bDMARDs) at the time they filled the questionnaire.

Table 1 Baseline Characteristics of Patients

An adherence rate of 79.01% was established. As for the secondary objectives, no differences were determined in adherence among patients related to the type of drugs they were receiving, bDMARDs versus cDMARDs (p = 0.1442), among patients receiving intravenous therapies versus other routes of administration (p = 0.7453) and among patients treated in specific day hospitals versus polyvalent day hospitals (p = 2.6815). The use of bDMARD combined with cDMARD also showed no difference in adherence compared to bDMARD monotherapy administration (p=0.314).

The univariate analysis detected the number of drugs and cohabitation as predictors of adherence to treatment (Table 2). When performing the multivariate analysis adjusted for sex and age, the same two variables remained as predictors of adherence, determining that both, number of drugs and cohabitation, are independent predictors of adherence.

Table 2 Association of Study Variables with Treatment Adherence

To test for sensitivity, the same statistical analysis was performed including all of the 859 patients, without ruling out the patients who skipped questionnaire items, considering these patients as non-adherents. The univariate analysis detected the same variables, number of drugs and cohabitation, as predictors of adherence to treatment (supplementary table 1). Civil status and age were also significant. Multivariate analysis adjusted for sex and age confirmed the number of drugs as an independent predictor of adherence.

Finally, ANOVA analysis was performed to test for sex and age influence on adherence and no statistical significance was detected.

This study conducted in Spanish population shows that adherence to treatment occurred in 79% of patients with RA. Multivariate analysis, adjusted for age and sex, revealed that a number of drugs and cohabitation were independently associated with adherence in this population.

There are currently different methods to assess medication adherence. A lack of consensus exists when determining which is the best instrument.14 This study was conducted using a highly reliable and specific tool, being the only rheumatology-specific adherence measure,8,9 that has been recently validated for its use in Spanish RA population.12 It must also be stressed the special effort that was made when selecting centers to participate in the study, having into account geographical distribution and other variables, such as population density and public health expenditure for each region, in order to obtain a representative sample of Spain. Results obtained in this study can be extrapolated to the total Spanish population.

The adherence rate of 79% detected in this study is similar to rates observed in previous studies performed in Spanish population where an adherence of 79% was detected for patients being treated with oral antirheumatic drugs15 and 85% in the case of SC bDMARDs.16 Reported adherence rates in literature are highly variable, ranging from 30% to 80%.8 A systematic review of the literature estimated a 66% adherence to medication in patients with RA.17 Different definitions, methods, treatments and populations are behind this variability making it difficult to determine the magnitude of the problem. Optimal adherence depends on the type of drug and it remains to be determined in RA, if we understand optimal adherence as the relation between adherence level and disease flare. Independently of the definition of optimal adherence, we must be ambitious and try to ensure that patients follow treatment instructions rigorously. Nonetheless, adherence to treatment in RA patients is still suboptimal.8

The type of treatment did not determine the adherence rate in our study. No differences were detected in adherence among patients receiving bDMARDs versus cDMARDS and/or glucocorticoids. To our knowledge, this is the first study that studies the relationship between the type of therapy used to treat RA and adherence.

Our findings suggest that route of administration does not have an impact on adherence. This is in line with what has been shown in previous studies, where adherence and persistence rates appeared broadly similar for the different routes of drug administration in RA.18

The multivariate analyses determined that the number of drugs was an independent predictor of adherence. This fact is especially relevant, considering that treatment strategies in patients with RA rely heavily on the combined use of steroids, cDMARDs and bDMARDs. Contradictory results related to the impact of the number of medications on adherence have been reported.1922 Regimen complexity (multiple medications, multiple doses, specific dietary or time requirements) has been related to poorer adherence in chronic diseases.23 Less frequent dosing has been related to better compliance.5,16 Simpler, more convenient dosing regimens resulted in better compliance.24 Since using complex regimens requires a good communication between doctor and patient, patients have to understand the consequences of not following the instructions correctly. Prescription needs to be a shared decision process, in order to achieve a consensus. Patient empowerment may have a positive effect on adherence; however, highly empowered patients might believe that they can make treatment decisions. Intelligent non-adherence is becoming a common term. Patients have to be properly informed.

The second independent predictor of adherence in this study was the cohabitation status. Living alone has been previously associated with poor adherence.25,26 Social support seems to be an important factor contributing to proper compliance. Family support has been related to an improvement in adherence to bDMARD in RA.27

Duration of disease, civil status, education level, sex and age were not identified as predictors of adherence. These findings are in line with previous reports in which no evidence for any association with adherence was determined.14

The study has several limitations. The study design, being cross-sectional, has to be considered. Adherence is not stable over time, having a dynamic nature.8 To address this issue, the inclusion of patients was not determined by disease duration so that patients in different stages of disease were included (Table 2). Patients had to be treated for at least 3 months but no upper limit on treatment duration was established. Disease activity was not measured and this variable may have an impact on adherence. Study population was not selected based on disease activity, participants reflected real-life RA population treated in routine clinical practice. Another disadvantage is the use of a self-reported questionnaire to test for adherence, even though it is a highly specific method with a highly predictive value,12 this method is relatively insensitive, since patients may claim to be adherent to avoid caregiver disapproval.8 Despite this, the use of indirect methods as the one used in this study is a more simple and feasible way to evaluate adherence and due to its highly predictive value, it can be used as a screening instrument.12

Increased knowledge of the impact of therapeutic compliance on patients with RA, and the identification of possible predictors of adherence to treatment allows to develop strategies to favor adherence to treatments and avoid problems arising from lack thereof. In any case, prescription needs to be a shared decision process where clinicians and patients can discuss their concerns and expectations, in order to achieve a consensus that will favor adherence to treatment.

Alegre Sancho JJ, Almodovar Gonzalez R, Barbazan Alvarez C, Bernad Pineda M, Blanco Alonso R, Blanco Madrigal JM, Caliz Caliz R, Calvo Alen J, Calvo Catala J, Carrasco Cubero C, Castao Sanchez M, Chamizo Carmona E, De Toro Santos FJ, Delgado Beltran C, Eges Dubuc A, Escudero Contreras A, Fernandez Nebro A, Gamero Ruiz F, Garcia Aparicio A, Hernandez Cruz B, Guerra Vazquez JL, Hernandez Miguel MV, Lopez Lasanta M, Marenco de la Fuente JL, Muoz Fernandez Santiago, Navarro Blasco FJ, Nolla Sole JM, Ornilla Laraundogoitia E, Ortiz Garcia A, Pablos Alvarez JL, Perez Esteban S, Perez Garcia C, Roman Ivorra J, Romero Yuste S, Rosello Pardo R, Salvador Alarcon G, Tornero Molina J, Urruticoechea Arana A, Vela Casasempere P.

This study was financed by Roche Farma S.A. Spain.

Dr Manuel Pombo-Suarez reports grants from Roche Farma S.A. Spain, during the conduct of the study. The authors report no other conflicts of interest in this work.

1. Scott DL, Wolfe FHT. Rheumatoid Arthritis. Lancet. 2010;376:10941108.

2. Smolen JS, Landew R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76:960977. doi:10.1136/annrheumdis-2016-210715

3. Vrijens B, De Geest S, Hughes DA, et al. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012;73:691705. doi:10.1111/j.1365-2125.2012.04167.x

4. Shafrin J, Bognar K, Everson K, Brauer M, Lakdawalla DN, Forma FM. Does knowledge of patient non-compliance change prescribing behavior in the real world? A claims-based analysis of patients with serious mental illness. Clin Outcomes Res. 2018;Volume 10:573585. doi:10.2147/CEOR.S175877

5. De Klerk E, Van der Heijde D, Landew R, Van der Tempel H, Urquhart J, Van der Linden S. Patient compliance in rheumatoid arthritis, polymyalgia rheumatica, and gout. J Rheumatol. 2003.

6. Harrold LR, Andrade SE. Medication adherence of patients with selected rheumatic conditions: a systematic review of the literature. Semin Arthritis Rheum. 2009;38:396402. doi:10.1016/j.semarthrit.2008.01.011

7. Osterberg L, Blaschke T. Drug therapy: adherence to medication. N Engl J Med. 2005;353:487497. doi:10.1056/NEJMra050100

8. Van Den Bemt BJF, Zwikker HE, Van Den Ende CHM. Medication adherence in patients with rheumatoid arthritis: A critical appraisal of the existing literature. Expert Rev Clin Immunol. 2012;8:337351. doi:10.1586/eci.12.23

9. De Klerk E, Van Der Heijde D, Van Der Tempel H, Van Der Linden S. Development of a questionnaire to investigate patient compliance with antirheumatic drug therapy. J Rheumatol. 1999.

10. De Klerk E, Van Der Heijde D, Landew R, Van Der Tempel H, Van Der Linden S. The compliance-questionnaire-rheumatology compared with electronic medication event monitoring: a validation study. J Rheumatol. 2003.

11. Lee JY, Lee SY, Hahn HJ, Son IJ, Hahn SG, Lee EB. Cultural adaptation of a compliance questionnaire for patients with rheumatoid arthritis to a korean version. Korean J Intern Med. 2011;26:28. doi:10.3904/kjim.2011.26.1.28

12. Salgado E, Fernndez JRM, Vilas AS, Gmez-Reino JJ. Spanish transcultural adaptation and validation of the English version of the compliance questionnaire in rheumatology. Rheumatol Int. 2018. doi:10.1007/s00296-018-3930-7

13. Carmona L. The prevalence of rheumatoid arthritis in the general population of Spain. Rheumatology. 2002;41:8895. doi:10.1093/rheumatology/41.1.88

14. Pasma A, Vant Spijker A, Hazes JMW, Busschbach JJV, Luime JJ. Factors associated with adherence to pharmaceutical treatment for rheumatoid arthritis patients: A systematic review. Semin Arthritis Rheum. 2013;43:1828. doi:10.1016/j.semarthrit.2012.12.001

15. Marras C, Monteagudo I, Salvador G, et al. Identification of patients at risk of non-adherence to oral antirheumatic drugs in rheumatoid arthritis using the Compliance Questionnaire in Rheumatology: an ARCO sub-study. Rheumatol Int. 2017;37:11951202. doi:10.1007/s00296-017-3737-y

16. Calvo-Aln J, Monteagudo I, Salvador G, et al. Non-adherence to subcutaneous biological medication in patients with rheumatoid arthritis: A multicentre, non-interventional study. Clin Exp Rheumatol. 2017.

17. Scheiman-Elazary A, Duan L, Shourt C, et al. The rate of adherence to antiarthritis medications and associated factors among patients with rheumatoid arthritis: A systematic literature review and metaanalysis. J Rheumatol. 2016;43:512523. doi:10.3899/jrheum.141371

18. Fautrel B, Balsa A, Van Riel P, et al. Influence of route of administration/drug formulation and other factors on adherence to treatment in rheumatoid arthritis (pain related) and dyslipidemia (non-pain related). Curr Med Res Opin. 2017;33:12311246. doi:10.1080/03007995.2017.1313209

19. Treharne GJ, Lyons AC, Kitas GD. Medication adherence in rheumatoid arthritis: effects of psychosocial factors. Psychol Heal Med. 2004;9:337349. doi:10.1080/13548500410001721909

20. Van Den Bemt BJF, Van Den Hoogen FHJ, Benraad B, Hekster YA, Van Riel PLCM, Van Lankveld W. Adherence rates and associations with nonadherence in patients with rheumatoid arthritis using disease modifying antirheumatic drugs. J Rheumatol. 2009;36:21642170. doi:10.3899/jrheum.081204

21. Park DC, Hertzog C, Leventhal H, et al. Medication adherence in rheumatoid arthritis patients: older is wiser. J Am Geriatr Soc. 1999;47:172183. doi:10.1111/j.1532-5415.1999.tb04575.x

22. Kristensen LE, Saxne T, Nilsson J, Geborek P. Impact of concomitant DMARD therapy on adherence to treatment with etanercept and infliximab in rheumatoid arthritis. Results from a six-year observational study in southern Sweden. Arthritis Res Ther. 2006;54:600606. doi:10.1186/ar2084

23. Ingersoll KS, Cohen J. The impact of medication regimen factors on adherence to chronic treatment: A review of literature. J Behav Med. 2008;31:213224. doi:10.1007/s10865-007-9147-y

24. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23:12961310. doi:10.1016/S0149-2918(01)80109-0

25. Lorish CD, Richards B, Brown S. Missed medication doses in rheumatic arthritis patients: intentional and unintentional reasons. Arthritis Care Res. 1989;2:39. doi:10.1002/anr.1790020103

26. De Cuyper E, De Gucht V, Maes S, Van Camp Y, De Clerck LS. Determinants of methotrexate adherence in rheumatoid arthritis patients. Clin Rheumatol. 2016;35:13351339. doi:10.1007/s10067-016-3182-4

27. Morgan C, McBeth J, Cordingley L, et al. The influence of behavioural and psychological factors on medication adherence over time in rheumatoid arthritis patients: A study in the biologics era. Rheumatol. 2015. doi:10.1093/rheumatology/kev105

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[Full text] Adherence to Treatment in Patients with Rheumatoid Arthritis from Spai | PPA - Dove Medical Press

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Health-related quality of life in rheumatoid arthritis: Systematic review and meta-analysis of EuroQoL (EQ-5D) utility scores from Asia – DocWire News

January 27th, 2021 9:51 am

Introduction:Region-specific health-related quality of life (HRQoL) scores or utility values are representative and pivotal for economic evaluations as they are influenced by the value judgment of the local population. This study systematically reviewed and pooled EuroQoL-5 Dimension (EQ-5D) utility scores of rheumatoid arthritis (RA) across primary studies from Asia.

Methods:Studies reporting EQ-5D utility scores among adult RA patients from Asian countries were systematically searched in PubMed-Medline, Scopus and Embase since inception through February 2020. Selected studies were systematically reviewed and study quality assessment was performed. Meta-analysis was performed using a random-effect model with subgroup and meta-regression analysis to explore heterogeneity.

Results:Among 1391 searched articles, 37 studies with 31 983 participants were systematically reviewed and meta-analysis was conducted among 31 studies. The pooled EQ-5D scores and EQ-5D visual analog score were 0.66 (95% CI 0.63-0.69, I2= 99.65%) and 61.21 (50.73-71.69, I2= 99.56%) respectively with high heterogeneity. For RA patients with no, low, moderate and high disease activity based on Disease Activity Score (DAS)-28, the pooled EQ-5D scores were 0.78 (0.65-0.90), 0.73 (0.65-0.80), 0.53 (0.32- 0.74), and 0.47 (0.32-0.62), respectively. On meta-regression, age of patients (P < .05) was positively associated and use of glucocorticoids (P < .05) was inversely associated with utility values.

Conclusion:Lower EQ-5D scores were associated with severe disease activity, increasing age and female gender among RA patients. The study provides pooled EQ-5D scores for RA patients that are useful inputs for cost-utility studies in Asia.

Keywords:EQ-5D-3L health utility; EQ-5D-5L; rheumatoid arthritis.

Link:
Health-related quality of life in rheumatoid arthritis: Systematic review and meta-analysis of EuroQoL (EQ-5D) utility scores from Asia - DocWire News

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Comparing DAS28-ESR and DAS28-CRP in Patients with Rheumatoid Arthritis – Rheumatology Advisor

January 27th, 2021 9:51 am

Among patients with newly diagnosed rheumatoid arthritis (RA), Disease Activity Score 28-joint count (DAS28) characterized using C-reactive protein (CRP) values are lower than the corresponding score using erythrocyte sedimentation rate (ESR) values, both at baseline high disease activity and post-treatment, according to study results published in ACR Open Rheumatology.

Disease activity scores are used to guide treatment and determine the efficacy of therapeutic strategies. Previous studies have shown that DAS28-CRP values are lower than DAS28-CRP values, but current guidelines do not provide specific cutoffs for high disease activity for each of the scores.

Existing studies that compared DAS28-CRP and DAS28-ESR used data from patients who received immunosuppressive therapy. The objective of the current study was to compare the scores from immunosuppressive treatment-nave patients.

The retrospective electronic chart review included 171 immunosuppressive treatment-nave patients with newly diagnosed RA. DAS28-CRP and DAS28-ESR were compared according to the cutoff value for baseline high disease activity (>5.1). A receiver operator characteristic curve (ROC) and Youden index were used to calculate the DAS28-CRP high disease activity optimal cut-point value corresponding to DAS28-ESR >5.1.

At baseline, the mean DAS28-ESR was higher than the mean DAS-28 CRP (5.1 1.2 vs. 4.1 1.0; P <.001) and more patients met high disease activity criteria for DAS28-ESR than for DAS28-CRP (48.5% vs. 14.6%, respectively). ROC curve and Youden index analysis showed that the cutoff point estimation of high disease activity using DAS28-ESR >5.1 corresponded to a DAS28-CRP score <4.06 (area under the ROC curve = 0.93, P =.000).

Data on both DAS28-ESR and DAS28-CRP score following treatment were available for 151 patients. On average, DAS28-CRP values were 0.66 points higher than the corresponding DAS28-ESR. DAS28-CRP values were significantly lower compared with DAS28-ESR in all subgroups classified by gender, age, and disease severity.

In patients in remission (values <2.6), mean DAS28-CRP values were 0.36 points lower than the corresponding DAS28-ESR value (1.45 vs. 1.81, respectively).

The study had several limitations, including the racially homogeneous cohort (91.8% white), single center study, as well as lack of data on body mass index or comorbidities which may have a significant impact on the difference between DAS28-ESR and DAS28-CRP.

There is a difference between DAS28-ESR and DAS28-CRP, even when calculated for immunosuppressive treatmentnave patients. DAS28-CRP is significantly lower than DAS28-ESR, wrote the researchers.

Greenmyer JR, Stacy JM, Sahmoun AE, Beal JR, Diri E. DAS28-CRP cutoffs for high disease activity and remission are lower than DAS28-ESR in rheumatoid arthritis. ACR Open Rheumatol. 2020;2(9):507-511. doi:10.1002/acr2.11171

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Comparing DAS28-ESR and DAS28-CRP in Patients with Rheumatoid Arthritis - Rheumatology Advisor

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