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vTv Therapeutics Announces Topline Results of Phase 2 Elevage Study of Azeliragon in Patients with Mild Alzheimer’s Disease and Type 2 Diabetes -…

December 16th, 2020 9:54 pm

HIGH POINT, N.C., Dec. 15, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc.(Nasdaq: VTVT) today announced that the Phase 2 Elevage study of azeliragon in people with mild Alzheimers disease and type 2 diabetes did not meet its primary objective of demonstrating an improvement in cognition as assessed by the 14-item Alzheimers Disease Assessment Scale Cognitive Subscale (ADAS-cog14) relative to placebo. The 6-month trial investigated the efficacy and safety of 5 mg azeliragon administered orally once daily compared to placebo in 43 people with mild probable Alzheimers disease and type 2 diabetes. The azeliragon treated group (n=21) had a 1.8 point decline from baseline in ADAS-cog14 compared to a placebo (n=22) decline of 0.35. These differences were not statistically significant. Consistent with previous studies, azeliragon was generally well-tolerated with similar incidences of treatment-emergent adverse events overall and by system organ class in both treatment groups.

We will continue to analyze the data to determine if there are potential benefits or future applications for azeliragon in Alzheimers, dementia or related indications that we or other interested parties may seek to pursue, said Steve Holcombe, chief executive officer, vTv Therapeutics. On behalf of vTv Therapeutics, we would like to extend our most sincere and heartfelt gratitude to study participants, their families, physicians and caregivers for their commitment to this important study despite the challenging circumstances created by the COVID-19 pandemic.

AboutvTv TherapeuticsvTv Therapeutics Inc.is a clinical-stage biopharmaceutical company focused on developing oral small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes, Alzheimers and related dementia, and inflammatory disorders. vTvs development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), genetic mitochondrial diseases, and chronic kidney disease. For more information, please visitwww.vtvtherapeutics.comor follow us on Twitter: @vTvTherapeutics.

Forward-Looking StatementsThis release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms anticipate, believe, could, estimate, expect, intend, may, plan, potential, predict, project, should, target, will, would and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading Risk Factors in our Annual Report on Form 10-K and our other filings with theSEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

Contacts

Investors:

Corey DavisLifeSci AdvisorsCDavis@LifeSciAdvisors.com

or

Media:Glenn SilverLazar FINN Partners646-871-8485gsilver@lazarpartners.com

Source: vTv Therapeutics Inc.

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10 Warning Signs That You Might Have Diabetes – 24/7 Wall St.

December 16th, 2020 9:54 pm

Special Report

December 15, 2020 1:02 pm

People living with diabetes are at a higher risk of developing severe COVID-19. A study published in the Lancet Diabetes & Endocrinology journal examined the medical records of 61.4 million people in the U.K. and found that 30% of COVID-19 deaths occurred in people with diabetes.

About one in 10 Americans, or 34.2 million people, live with diabetes, according to the Centers for Disease Control and Prevention data through 2018. Other findings from the data show that one in three people in the country have prediabetes, higher than normal blood sugar level, which can turn into diabetes if left untreated, and that new cases have been skyrocketing among young people.

Some of the most severe diabetes complications include ketoacidosis, which can be fatal, kidney disease, amputation, and blindness. And there is a new risk associated with the disease.24/7 Tempo reviewed multiple studies and reports by independent health organizations, such as the American Diabetes Association, and JDRF, a leading Type 1 diabetes research group, to compile a list of the 10 biggest warning signs of diabetes.

There are three types of diabetes. People with Type 1 diabetes, about 5%-10% of those with the disease, make very little or no insulin a hormone made by the pancreas that helps regulate blood sugar levels in the body by allowing cells to store the broken down sugars, or glucose (the bodys energy source). They must take insulin every day to live. People with Type 2 diabetes dont use insulin well. Their body is not capable of regulating blood sugar levels. The third type, gestational diabetes, develops in pregnant women. Blood sugar levels usually return to normal after childbirth.

Some diseases, including diabetes, have a particular odor and vague symptoms that seem completely normal daily activities like drinking coffee and eating cookies. Here are 18 ordinary habits that can be signs of serious health problems.

Click here to read about the 10 warning signs you may have diabetes.

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Data shows diabetes levels in England have trebled in 25 years – Nursing Times

December 16th, 2020 9:54 pm

The proportion of adults with diagnosed diabetes trebled in England between 1994 and 2019, according to latest research.

The findings, which relate to both type 1 and type 2 diabetes, are based on analysis of the latest results from the Health Survey for England 2019, which is commissioned by NHS Digital.

Covid-19 has rightly prompted greater focus on obesity reduction, which will also help with the problem of rising diabetes

Jenny Mindell

Researchers from University College London and the National Centre for Social Research analysed data from over 8,200 adults and 2,000 children living in private households in England

Their report shows the percentage of people who have been diagnosed with diabetes has risen since 1994, from 3% to 9% among men and from 2% to 6% among women.

They found total diabetes including both diagnosed cases and those found by the survey to have undiagnosed diabetes was much more common among people with lower incomes and obesity.

For example, 16% of people in the lowest income group had diabetes but only 7% in the highest income group.

Meanwhile, the proportion of adults with total diabetes increased from 5% of those with normal weight to 9% of adults with overweight and 15% of adults with obesity.

Additionally, the report highlighted that adults living in the most deprived areas were the most likely to be obese.

The difference was particularly pronounced for women, where 39% in the most deprived areas were obese, compared with 22% in the least deprived areas.

Professor Jenny Mindell, co-editor of the report, said: We have known for a long time that diabetes increases the risks of developing circulatory diseases and cancers.

We have seen this year that it also increases the risks of serious infection and death in people infected with Covid-19. Diabetes is much more common in people with obesity.

The Covid-19 pandemic has rightly prompted greater focus on obesity reduction, which will also help with the problem of rising diabetes, she added.

For the first time, the annual survey also asked about GP consultations, revealing that 69% of men and 82% of women had consulted a GP in the previous 12 months.

In addition, 84% of respondents had consulted their GP solely for a physical health problem, 5% for a mental health, nervous or emotional problem and 11% for both types of problem in the last 12 months.

Women were more likely than men to have discussed a mental health problem with their GP and to use counselling or therapy services for a mental health problem.

Consultations for mental health problems were more common among those from lower incomes 25% of adults in the lowest income group had one in the last year compared with 15% in the highest.

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The coronavirus may sometimes slip its genetic material into human chromosomesbut what does that mean? – Science Magazine

December 16th, 2020 9:53 pm

The pandemic coronavirus SARS-CoV-2 (shown above) mayunder certain conditionsintegrate its genetic material into human cells, confounding COVID-19 diagnostic tests.

By Jon CohenDec. 16, 2020 , 6:30 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

People who recover from COVID-19 sometimes later test positive for SARS-CoV-2, suggesting their immune systems could not ward off a second attack by the coronavirus or that they have a lingering infection. A study now hints at a different explanation in which the virus hides in an unexpected place. The work, only reported in a preprint, suggests the pandemic pathogen takes a page from HIV and other retroviruses and integrates its genetic codebut, importantly, just parts of itinto peoples chromosomes. The phenomenon, if true and frequent, could have profound implications that range from false signals of active infection to misleading results from COVID-19 treatment studies.

The current study only showed this integration in a lab dish, although it also cites published sequence data from humans infected with SARS-CoV-2that suggest it has happened. The authors emphasize that their results dont imply that SARS-CoV-2 establishes permanent genetic residence in human cells to keep pumping out new copies, as HIV does.

Other scientists are divided about the importance of the new work and its relevance to human health, and some are harshly critical. There are open questions that well have to address, saysmolecular biologist Rudolf Jaenisch of the Massachusetts Institute of Technology (MIT), who led the work.

Yet a few veteran retrovirologists are fascinated. This is a very interesting molecular analysis and speculation with supportive data provided, says Robert Gallo, who heads the Institute of Human Virology and looked at the newly posted preprint at Sciences request. I do not think it is a complete story to be certain but as is, I like it and my guess is it will be right.

All viruses insert their genetic material into the cells they infect, but it generally remains separate from the cells own DNA. Jaenischs team, intrigued by reports of people testing positive for SARS-CoV-2 after recovering, wondered whether these puzzling results reflected something of an artifact from the polymerase chain reaction (PCR) assay, which detects specific virus sequences in biological samples such as nasal swabs, even if they are fragmented and cant produce new viruses. Why do we have this positivity, which is now seen all over the place, long after the active infection has disappeared? says Jaenisch, who collaborated with the lab of MITs Richard Young.

To test whether SARS-CoV-2s RNA genome could integrate into the DNA of our chromosomes, the researchers added the gene for reverse transcriptase (RT), an enzyme that converts RNA into DNA, to human cells and cultured the engineered cells with SARS-CoV-2. In one experiment, the researchers used an RT gene from HIV. They also provided RT using human DNA sequences known as LINE-1 elements, which are remnants of ancient retroviral infections and make up about 17% of the human genome. Cells making either form of the enzyme led to some chunks of SARS-CoV-2 RNA being converted to DNA and integrated into human chromosomes, the team reports in their preprint, posted on bioRxiv on 13 December.

If the LINE-1 sequences naturally make RT in human cells, SARS-CoV-2 integration might happen in people who have COVID-19. This could occur in people coinfected with SARS-CoV-2 and HIV, too. Either situation may explain PCR detecting lingering traces of coronavirus genetic material in people who no longer have a true infection. And it could confuse studies of COVID-19 treatments that rely on PCR tests to indirectly measure changes in the amount of infectious SARS-CoV-2 in the body.

David Baltimore, a virologist at the California Institute of Technology who won the Nobel Prize for his role in discovering RT, describes the new work as impressive and the findings as unexpected but he notes that Jaenisch and colleagues only show that fragments of SARS-CoV-2s genome integrate. Because it is all pieces of the coronaviral genome, it cant lead to infectious RNA or DNA and therefore it is probably biologically a dead end, Baltimore says. It is also not clear if, in people, the cells that harbor the reverse transcripts stay around for a long time or they die. The work raises a lot of interesting questions.

Virologist Melanie Ott, who studies HIV at the Gladstone Institute of Virology and Immunology, says the findings are pretty provocative but need thorough follow-up and confirmation. I have no doubt that reverse transcription can happen in vitro with optimized conditions, Ott says. But she notes that SARS-CoV-2 RNA replication takes place in specialized compartments in the cytoplasm. Whether it happens in infected cells and leads to significant integration in the cell nucleus is another question.

Retrovirologist John Coffin of Tufts University calls the new work believable, noting that solid evidence shows that LINE-1 RT can allow viral material to integrate in people, but hes not yet convinced. The evidence of SARS-CoV-2 sequences in people, Coffin says, should be more solid, and the in vitro experiments conducted by Jaenischs team lack controls he would have liked to have seen. All in all, I doubt that the phenomenon has much biological relevance, despite the authors speculation, Coffin says.

Zandrea Ambrose, a retrovirologist at the University of Pittsburgh, adds that this kind of integration would be extremely rare if it does indeed happen. She notes that LINE-1 elements in the human genome rarely are active. It is not clear what the activity would be in different primary cell types that are infected by SARS-CoV-2, she says.

One particularly harsh Twitter critic, a postdoctoral researcher in a lab that specializes in retroviruses, went so far as to call the preprints conclusions a strong, dangerous, and largely unsupported claim. Jaenisch emphasizes that the paper clearly states the integration the authors think happens could not lead to the production of infectious SARS-CoV-2. Lets assume that we can really resolve these criticisms fully, which Im trying to do, Jaenisch says. This might be something not to worry about.

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Oklahoma researchers looking for additional patients across the US with rare genetic mutation – KFOR Oklahoma City

December 16th, 2020 9:53 pm

OKLAHOMA CITY (KFOR) Behind one Oklahoma 8-year-olds infectious smile is a fighter.

Im smaller than most people, said Madison Cain.

Madison was born smaller than most babies, too, at 5 lbs. 9 oz.

She was teeny tiny, she calls herself a little itty-bitty baby,said Madisons mom, Melissa Cain.

For Madisons first year, Melissa says there werent many issues.

Around 15 months or so she quit growing in length, she quit gaining weight, and so that began our journey to figure out what was going on, said Melissa.

The Tulsa residents had no idea what this journey would entail.

By age two, Madison was diagnosed with hip dysplasia and cataracts.

She got those initial diagnoses treated, but still wasnt growing.

Then we really started thinking this isnt all adding up she doesnt grow, she has the hip thing, she has cataracts, there has to be something, said Melissa.

The family started genetic testing, while Madisons symptoms persisted.

Still low energy not growing well, said Melissa. She couldnt keep up with her peers, you know running and things werent the same we were doing all kinds of things and just not a lot of answers.

The Cains spent hours researching, and even more time at the doctors office, but it was years of dead ends.

No energy, sleeping 16 hours a day barely making it through school, not gaining any weight, said Melissa.She was 5 and weighed about 25-28 pounds, but she is the most easy going, not stressed out, tough child.

Madisons strength paid off.

A break-through finally coming in 2019.

The genetics doctor called and said here this is what it is, theres one published paper, with a patient with this. Its not her, so well just put it in a database and see if anything ever hits, said Melissa.

But as a nurse practitioner herself, Melissa sat down and read the article.

She realized it was written by doctors, just down the turnpike, at the Oklahoma Medical Research Foundation.

This is a new disease and were the first ones that discovered it, said Dr. Lijun Xia,Member and Chair, Cardiovascular Biology Research Program at OMRF.

Madison has rare gene mutation to the MBTPS1 gene.

Madison, inherited a wrong copy from her mother and the father so, therefore even though she has two copies of the gene both are wrong both have mutation, said Dr. Xia.

The mutation, resulted in a condition called Spondyloepiphyseal Dysplasia, Kondo-Fu type, or SEDKF for short.

The condition named after two of Oklahomas scientists.

The disorder hinders Madisons bone growth and development.

This is a very rare genetic disease,said Dr. Xia.

There are only two known cases in the state, Madisons and another girl named Sydney in Yukon, who was the first diagnosed.

Since publishing the article, OMRF now knows of about eight cases worldwide.

We have one contact us from Germany, one from Brazil, and theres also one from San Francisco, said Dr. Xia.

Doctors think that could be because many patients are misdiagnosed.

The mutation can also affect every patient differently.

However, theres hope on the horizon.

Researchers have come up with a possible treatment but need 50 patients for a clinical trial.

Now theyre searching for cases across the country.

Of course, I wish that we had the answer plus enough patients to do a trial and see if the treatment would work and Im hopeful that we can get there before her bones stop growing, said Cain.

The protein used for treatment has already been approved by the FDA to treat a different disease.

Researchers have tested the treatment on mice successfully.

For Madison, this treatment could mean everything.

It could change our life and change her life for the rest of her life, said Cain. We never thought weve get a Madison, but theres no one like Madison.

For more information visit the OMRF website.

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Your Cancer Answers: Which genetic syndromes increase the risk of breast cancer? – Lompoc Record

December 16th, 2020 9:53 pm

Question: Which genetic syndromes increase the risk of breast cancer?

Many risk factors for breast cancer have been identified, including genetic, environmental, and lifestyle factors. Some are modifiable and others are not. A family history of breast cancer in a first-degree relative is the most widely recognized breast cancer risk factor, but only 5-10% of women diagnosed with breast cancer have a known genetic predisposition. Women with a family history of breast cancer in a mother or sister have a 1.5-3 fold increase in the risk of developing breast cancer.

Multi-panel genetic testing for hereditary breast cancer syndromes is currently not standard for all women diagnosed with breast cancers due to insufficient data regarding interpretation accuracy and its utility. For now, BRCA1/2 testing accounts for half of the detected genetic breast mutations and is recommended in a women with: Personal history of breast cancer diagnosed before the age of 50, multiple female relatives with breast cancer on same side of the family or family history of male breast cancer, multiple breast cancers, both breast and ovarian cancer,with Ashkenazi Jewish heritage.

Those with BRCA mutation are at risk for developing breast cancer (50 to 80%) by age 70 and developing ovarian cancer (40-60%) by age 85. Since 2014, PALB2 (partner and localizer of BRCA2 gene) testing is frequently added to BRCA due to its inherent breast cancer risk of 5 to 9 times the average. Optional genetic panel testing includes PTEN, TP53, ATM, CDH1, CHEK2, NBN, NF1, STK11, and PMS2/MSH2 Lynch syndrome, also known as hereditary non-polyposis colorectal cancer, is a hereditary cancer syndrome, and is associated with multiple types of cancers, particularly colon, ovarian and endometrial/uterine, as well as breast cancers. Women with these mismatch repair genetic mutations (Lynch) may also have a 2-3 fold increase risk of breast cancer compared to the general population.

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Life With RA: You Are Your Best Advocate – WebMD

December 16th, 2020 9:51 pm

By Alexandra Benisek

For the first decade of her life, Saada Branker enjoyed a normal, active childhood in Montreal. But after a year of unexplained pain in her shoulders, hands, and feet, her doctor diagnosed her with polyarticular juvenile rheumatoid arthritis, now called juvenile idiopathic arthritis (JIA), when she was 12.

That news 40 years ago surprised Brankers parents. It was uncommon then -- as it is today -- to hear of children with arthritis. By the time Branker entered high school, her condition was severe enough to often leave her stuck on the sidelines.

The toughest part was sitting in gym class, watching the students do the things that I used to do, says Branker, 51, a freelance writer and editor in Toronto. I was sitting on this skinny bench on the side of the gym for 40 minutes, watching them do the things I couldnt do.

Branker disliked feeling like an outcast so much that she spent years covering up her disease. Only several dozen American children under 16 out of 100,000 have it. The type Branker had is rarer still. Polyarticular means the disease affects five or more big and small joints, such as in the ankles and feet.

As Branker approached adulthood, her JIA became classified as rheumatoid arthritis (RA). The condition took a toll not just on Brankers body but on her mental well-being. I started to feel very self-conscious, I felt different. In high school, you dont want to be different, you want to blend in.

The discomfort seeped into other parts of Brankers life. It followed her to Ryerson Universitys journalism program in Toronto, where she found the transition to college life-altering and stressful with RA. Even though I was looking forward to it, it impacted me physically, she says.

The pain and stiffness from RA slowly made impossible the most routine of daily tasks. She could no longer twist her dreadlocks or drive her friends downtown. At her most pessimistic point, Branker simply assumed that shed eventually lose her mobility and independence.

Branker started her first job out of college as a program assistant at the Canadian Broadcasting Corporation just after having surgery on her elbow because of RA. Her duties included lifting and moving items, something her doctor advised her to avoid. But Branker was reluctant to confide to her employer.

I didnt want anyone to know, she says. My challenge all the time was, How do I look able-bodied like everyone else? What was more important to me at the time was fitting in and doing the job.

In fact, Branker kept her illness a secret -- until she couldnt. One morning in June 2001, she realized that she couldnt put on her clothes.

When I went to get dressed, I couldnt raise my arms to get the blouse on. I had to call my roommate to help dress me. That was the morning I decided Im just going to tell everyone at work that Ive been struggling with this disease.

Branker switched from blending in to speaking up. She also began to see a social worker to learn how to manage a lifelong illness mentally. Through that, I developed this understanding that, not only do I need to talk about it, but people need to hear about this disease.

Branker learned how to lean on others. People were so kind and would help. But it was also hard for me to accept. It always took a chunk out of me.

Branker used to fear for her future as her disease progressed. But she now realizes that the best path is to accept the unknown.

Losing mobility is something that we have to be real with ourselves about. When we lose the mobility, it doesnt mean its gone forever. But at that moment, you have to mourn the loss.

Branker urges other with RA to be kind to themselves and to make their health their top priority.

With her newfound self-advocacy, Branker acts as a team player for her treatment. She brings a list of questions to doctors appointments, does her research, and speaks up for therapy that she thinks may work best for her lifestyle.

All of that started to become comfortable and then normal for me. I started looking at [the physicians] as my team and not just doctors who teach me what to do. That shift helped empower me, she says.

Branker also takes advantage of assistive devices, including tools to help put on her socks or to grip cooking items.

For each task she cant finish, Branker is determined to adapt and to gain a new perspective.

Instead of looking at it as I cant do it, its gone forever, I think, What can I do in place of that? she says. You dont have to keep walking around, thinking I got to act like everyone else and act like I can do this when on some days, you cant, and thats OK.

WebMD Feature

SOURCES:

Saada Branker, Toronto, Canada.

Mayo Clinic: Juvenile idiopathic arthritis.

Pediatric Orthopaedic Society of North America: Juvenile Idiopathic Arthritis.

Arthritis Foundation: Juvenile Idiopathic Arthritis (JIA), Do Adults Have Juvenile Arthritis?

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Teen Becomes ‘Claus For A Cause’ To Raise Awareness Of Arthritis – Yankton Daily Press

December 16th, 2020 9:51 pm

On Saturday, Taylor Van Emmerik became Claus for a cause.

The 16-year-old, who was diagnosed with juvenile arthritis seven years ago, donned an inflatable Santa Claus outfit for a 5K (3.1 mile) run through Yankton. He triumphantly finished by crossing the upper deck of the Meridian Bridge, raising about $3,000 for the Arthritis Foundation.

This is part of the annual Jingle Bell Run fundraiser. Because of COVID, they werent having the large groups running together, he said. I decided to have a virtual run by myself, putting it on Facebook and YouTube for people to follow.

And the Santa outfit? Van Emmerik wore it in the spirit of the season and to raise more funds.

I bought it on Amazon for about $30, he said. I told people that I had to raise at least $2,500 for me to wear the Santa suit, and they came through.

Before he even started his run, Van Emmerik had traveled from his hometown of Tea, just outside Sioux Falls. His parents, Dean and Jodi Van Emmerik, operate a business in the community. Taylor attends Tea Area High School, while another son, Gavin attends eighth grade in the Tea schools.

Why come to Yankton to make the Jingle Bell Run?

Weve camped down at the Meridian Bridge resort (on the Nebraska side of the bridge), and Ive spent a good chunk of my summers there, he said. When I thought of running the 5K, I thought it would be cool to finish it by crossing the Meridian Bridge and finishing on the Nebraska side. Ive walked a mile for the Jingle Bell fundraiser, but this is my first 5K run.

On Saturday, Taylor donned his Santa suit at the corner of 29th and Douglas streets he mapped out the route and distance in northeast Yankton. He was accompanied by father; his grandmother, Mary Van Emmerik; and 10 friends affectionately described as his elves. Other family members were there in spirit, as Jodi was accompanying Gavin at his wrestling tournament.

Taylor laughed as he donned the inflatable Santa suit, but he turned serious as he spoke about his lifes journey. His struggle with arthritis began in his previous hometown, even though he didnt know what he was suffering at the time.

I came back from a trip to Mitchell, and I got out of the truck and just had this feeling on my left side. I went inside and took off my socks, and my ankle had swollen to the size of a water balloon. I didnt know what was going on, he said.

The next morning, my fingers were very stiff, and I couldnt loosen them enough to pull up my pants. Theres nothing more embarrassing when youre 9 years old than having your parents pull up your pants for you.

The pain became so bad that Taylor called to be taken home from school. Jodi took him to the local clinic, and he was sent to a pediatrician who was unsure of the condition but ruled out arthritis because Taylor didnt have the swelling in both ankles. His foot was placed in a boot, and he was sent home.

Dean said the family wasnt sure what to do. We were crushed, and we didnt know what to do and where to go for help, he said.

Jodi went online to search for more options. She learned one daunting statistic: More than 300,000 young people suffer from juvenile arthritis, with only about 420 pediatric rheumatologists in the nation and none of them were close to Taylor.

If you do the math, it comes out to 715 patients for each doctor, Taylor said of the odds for being seen by one of the specialists. The closest ones were located hours away in Minneapolis; Rochester, Minnesota; Omaha and Denver.

Taylor was seen by doctors at the Mayo Clinic in Rochester, who immediately diagnosed juvenile arthritis. He was placed on medication and scheduled for monthly visits, requiring an eight-hour round trip.

Jodi was the one who did a lot of work with scheduling and taking Taylor to appointments, while I stayed back and ran our business, Dean said. But now its made a huge difference that Sanford (Health System) brings down a pediatric rheumatologist from Fargo to Sioux Falls once a month. Taylor doesnt need to make those long trips.

When he was first diagnosed, Taylor was playing basketball, golf and soccer. As his condition worsened, he gave up those sports. However, his current passion for running has kept him moving, which he believes has been good for his arthritis.

Taylor has remained in school and has developed a number of close friends who have provided him with support. However, he suffered a physical setback when he had been in remission but the arthritis returned.

Its a lot of trial and error. We go back every few months to see if its working, he said. They have found something that seems to help, and we pray it stays that way.

While Taylor received support from others, he struggled mentally as others didnt understand what he was experiencing. At that point, the Van Emmeriks discovered Camp Cambria in Minnesota, which serves the needs for those with juvenile arthritis.

At first, I wasnt sure. A camp for a bunch of disabled kids? It didnt sound that cool. But my parents convinced me, Taylor said. I was scared. It was my first time away from home. I was the youngest male camper and the only one from South Dakota. But when I got to camp, there were a lot of friendly faces. It was life changing,

Dean could see the change in his son. The Cambria camp provided a big inspiration for Taylor. Its where he draws a lot of his energy, Dean said.

The camping experience also turned Taylor into an advocate for the Arthritis Foundation and for the recruitment of a full-time pediatric rheumatologist in Sioux Falls.

But Saturday, Taylors immediate goal was completing the 5K. He hadnt conducted a trial run in the Santa suit, which he admitted was a mistake. He was bogged down by the body mass, and he took off his fake beard for easier breathing. But the suit kept him warm in the freezing temperatures.

Im tired, but Im very happy and very glad I did this. It was really rewarding for my self-esteem to finish this. I told myself, You can do this, he said. My friends were awesome, but they were laughing at me all the time. They were jamming to Christmas music in the car while they were driving alongside me and were honking their horn at me. We had a few people who joined the parade (as I ran through Yankton), and it was very cool.

Dean watched the scene with a sense of satisfaction. Taylor carries a great attitude and a positive attitude. Were really proud of the man hes become, he said.

Taylor spoke with determination about his purpose, even if he was cold and tired from his run.

Arthritis doesnt control me, and it doesnt define me as a person, he said. Im doing this (run) for the 54 million people with arthritis and for the future generations and a cure, so it wont be necessary for any of us to deal with this anymore.

To donate or to learn more information, visit the Arthritis Foundation of South Dakota both online and on Facebook.

Follow @RDockendorf on Twitter

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CHMP Recommends the Approvals of RINVOQ (Upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis -…

December 16th, 2020 9:51 pm

NORTH CHICAGO, Ill., Dec. 11, 2020 /PRNewswire/ --AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of RINVOQ (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor, for the expanded use in two additional rheumatic indications: the treatment of adult patients with active psoriatic arthritis and adult patients with active ankylosing spondylitis.5 The CHMP positive opinions are based on results from three pivotal clinical studies in which RINVOQ demonstrated efficacy across multiple measures of disease activity.1-3

"The CHMP's recommendations to approve RINVOQ in both psoriatic arthritis and ankylosing spondylitis mark an important milestone. AbbVie is committed to continued research to advance treatment standards for patients living with these debilitating diseases," said Thomas Hudson, senior vice president, research and development, AbbVie. "If approved, RINVOQ will become an oral, once daily targeted treatment option across three rheumatic indications in the European Union. These recommendations pave the path towards helping more people living with psoriatic arthritis and ankylosing spondylitis find relief from their symptoms across multiple manifestations of the diseases."

In both the Phase 3 SELECT-PsA 1 and SELECT-PsA 2 clinical trials, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs, respectively.1,2

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 patients who were nave to biologic DMARDs and had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).3

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.1-4

The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. The Marketing Authorization would be valid in all member states of the European Union, as well as Iceland, Liechtenstein and Norway.

About Psoriatic Arthritis

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.6,7 In psoriatic arthritis, the immune system creates inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints.6,7

About Ankylosing Spondylitis

Ankylosing spondylitis is a chronic, inflammatory musculoskeletal disease primarily affecting the spine and characterized by debilitating symptoms of pain, limited mobility, structural damage and vertebral fractures.8,9

About SELECT-PsA 11,10

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 22,11

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 13,12

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 active ankylosing 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.10-20 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.10-12,14-20

Important Safety Information about RINVOQ (upadacitinib)5

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 75 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 are upper respiratory tract infections (13.5%), nausea (3.5%), increased blood creatine phosphokinase (2.5%), and cough (2.2%). The most common serious adverse reactions were serious infections.

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.

References:

SOURCE AbbVie

https://www.abbvie.com

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CreakyJoints Launches The Gout Show, a New Podcast Series and Educational Campaign – Business Wire

December 16th, 2020 9:51 pm

UPPER NYACK, N.Y.--(BUSINESS WIRE)--CreakyJoints, the digital arthritis community for patients and caregivers worldwide and part of the Global Healthy Living Foundation (GHLF), today announced the launch of The Gout Show, a new podcast series and digital destination to raise awareness of one of the most misunderstood and misdiagnosed forms of arthritis: gout. Hosted by Steve Clisby, a professional musician who was recently diagnosed with gout, the five-episode series features experts and fellow patients defining gout, debunking common myths, and sharing useful tips to help other patients take control of their health. In addition to the podcast, there are three bonus patient audio guides about gout diagnosis, risk factors, and the treatment landscape. The Gout Show section of the CreakyJoints website (creakyjoints.org/thegoutshow) includes a quiz about uncontrolled gout, and robust educational and support articles specific to gout. The podcast and patient audio guides are available everywhere podcasts are downloaded.

Even in 2020, there is a persistent myth that gout is a disease of the upper class, of kings, caused by indulgent consumption of rich foods and alcohol, but that generalization ignores science and the experience of gout patients, said Louis Tharp, Executive Director and Cofounder of CreakyJoints. The Gout Show explains this mythology and others, focusing on how people living with gout can recognize a flare and seek treatment to reduce their risk for pain, inflammation and joint damage, so that they can concentrate on the activities of life important to them. Too many people suffer from uncontrolled gout, and The Gout Show speaks directly to them with positive messages of hope and help.

Gout Facts, Not Fiction

It is estimated that nearly 4 percent of the U.S. population (or 9.2 million people) are living with gout, a form of arthritis that causes severe, sudden attacks of inflammation, often in the toe joints or other large joints. Attacks occur following an overproduction of urate in the blood (known as hyperuricemia), which causes uric acid crystals to build up in the joints and trigger debilitating pain. Gout is a genetic condition. While more men than women get gout, anyone is susceptible if their body doesnt properly break down uric acid before it crystallizes in the joints.

The good news is that gout is highly treatable, but in order to address it with our patients, they have to recognize their symptoms and report them to their doctor, said Payam Shakouri, MD, a nephrologist with Advanced Kidney Care of Hudson Valley in New York and a medical adviser to CreakyJoints. Not only can gout be disabling disruptive to a persons quality of life, but it can cause serious damage to joints, bones and organs. Im pleased to contribute advice on The Gout Show and encourage people living with gout to listen to the series and report any symptoms they might have to their health-provider team.

The Gout Show also includes expert advice from Theodore R. Fields, MD, a rheumatologist at the Hospital for Special Surgery and Professor of Clinical Medicine at Weill Cornell Medical College in New York City.

While physicians guide the science of the podcast, patients drive the narrative. I was surprised when at age 32 I was diagnosed with gout after experiencing pain in my knee. I thought it was a simple running injury that I could rehab, and I mistakenly thought gout started just in the big toe, said Ashley Newton, a CreakyJoints member who shares her gout story in episode one of The Gout Show. As Ive learned more about gout, Ive prioritized keeping up with my treatments, tracking my symptoms in CreakyJoints ArthritisPower Research Registry, and sharing what I know about gout with other people in the event they may be experiencing symptoms that need to be reported to a doctor.

The Gout Show is available on all major streaming platforms as well as on the CreakyJoints website. It was made possible by funding from Horizon Therapeutics.

About CreakyJoints

CreakyJoints is a digital community for millions of arthritis patients and caregivers worldwide who seek education, support, advocacy, and patient-centered research. We represent patients in English and Spanish through our popular social media channels, our websites CreakyJoints.org, CreakyJoints.org.es, CreakyJoints.org.au, and the 50-State Network, which includes more than 1,500 trained volunteer patient, caregiver, and health care activists.

As part of the Global Healthy Living Foundation, CreakyJoints also has a patient-reported outcomes registry called ArthritisPower (ArthritisPower.org) with more than 29,000 consented arthritis patients who track their disease while volunteering to participate in longitudinal and observational research. CreakyJoints also publishes the popular Raising the Voice of Patients series, which are downloadable patient-centered educational and navigational tools for managing chronic illness. It also hosts PainSpot (PainSpot.org), a digital risk assessment tool for musculoskeletal conditions and injuries, and eRheum (eRheum.org) for telehealth and virtual care support. For more information and to become a member (for free), visit CreakyJoints.org.

Find us on social media:

Facebook: facebook.com/CreakyJoints and facebook.com/GlobalHealthyLivingFoundation

Twitter: @GHLForg, @CreakyJoints, #CreakyChats

Instagram: @creaky_joints, @creakyjoints_aus, @creakyjoints_esp

YouTube: youtube.com/user/CreakyJointsInc

TikTok: globalhealthylivingfnd

LinkedIn: linkedin.com/company/ghlf

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Understanding the RA Pain Spectrum – HealthCentral.com

December 16th, 2020 9:51 pm

No two patients with any condition are exactly alike. But when it comes to rheumatoid arthritis (RA), it may seem like friends or support group members are having a totally different experience with pain and symptoms than that of you or your loved one. And thats because, oftentimes, they are. Unlike other diseases where there are telltale signs that most patients feel, this autoimmune disease can really affect people differently. While some patients severely struggle, experiencing consistent pain in all their joints, others may only have minor aches in their hands and feet, says Nilanjana Bose, M.D., a rheumatologist at the Rheumatology Center of Houston in Houston.

Elena Myasoedova, M.D., Ph.D, an associate professor of medicine and a senior associate consultant in rheumatology for The Mayo Clinic in Rochester, MN, says multiple studies have been conducted to better understand why symptoms vary so much by patient and there are still many unknowns. She explains that the level of RA disease activity, the number and location of involved joints and the presence of involvement of internal organs, as well as personal perception of pain and presence of other comorbidities may all affect how person feels about his RA and what symptoms they have.

Dr. Bose explains that some patients have pain in all joints, while others have pain in a few. The most typical joints that are affected are in the wrists and fingers, but even in more severe cases those areas might be spared or only an issue during a flare. Each patient is very different in the way they present, adds Veena K. Ranganath, M.D., associate clinical professor of medicine in the division of rheumatology at the David Geffen School of Medicine at UCLA in Los Angeles. Take, for example, Mary Sophia Hawks, age 58 of Knoxville, TN, whose RA was diagnosed in 2013 after a debilitating flare up where she experienced severe swollen joints all over her body, fatigue, and balance issues.

When I have a flare, everything hurts. All my joints, my muscles, everything. I can barely get to the bathroom and back to bed on those days, she says. Since then, shes had her knee replaced (doctors found that RA had eaten away at the bone, she says) and her toes are bent and dont straighten all the way. But so far, the disease hasnt adversely affected her hands, which is a more common symptom of RA, so shes able to work as a parish nurse at a local church. A positive attitude has been key in helping her live with the disease. I still go to church and sing in the choir. That brings me incredible joy.

Dr. Ranganath also says that a patients perception of their condition and pain acuity play a critical piece in how symptomatic they are. But being more sensitive to pain isnt all bad news: It can actually mean that you get diagnosed earlier, which may lead to a better outcome long term. Those who experience pain tend to seek help more quickly, she explains, which is good since its important to get on medication that can manage inflammation and prevent joint damage as well as the cardiovascular problems that are common among RA patients. Once we get the RA under control, overall outcomes are so much better, she says. (For those not experiencing pain, its key to see your doctor and have them refer you to a rheumatologist if they see physical signs of the disease.)

Dr. Bose adds that patients with concurrent mood and/or sleep disorderslike depression, anxiety, stress and insomniatend to have a lower pain threshold and will complain of pain and fatigue more. And much of the pain an RA patient feels can be affected by confounding factors like osteoarthritis and fibromyalgia, which can cause pain.

Just as pain and symptoms may differ, how well any certain medication works to quell them can also vary. And it can take some serious trial and error to find the best fit for you. Since RA is an autoimmune disease, Dr. Ranganath says that the majority of medications address the mechanism of action by suppressing the immune system from attacking itself. But what works for one patient may not work for another, Dr. Ranganath explains, due to each individuals different genetic composition and their unique environment. You have to be patient and flexible, says Hawks, who is a moderator and contributor to rheumatoidarthritis.net. You have to realize it will take a while to determine if your medication is working and not every medication works for everybody.

Dr. Bose also makes sure to take a holistic view when deciding how to proceed, treating the person as a whole, not just their RA. For example, if someone has ongoing depression or anxiety along with RA, she says its important to discuss managing mood problems, sleep issues, stress, lack of a good diet and lack of exercise, since all these conditions potentially can lead to inflammation and cause more pain.

Despite all that doctors dont know about RA and pain, Dr. Myasoedova says theres reason to be optimistic. Over the past three decades, the number of medications available for treatment of RA has increased dramatically, she said, with over 15 different medications that have been shown to prevent and/or delay progression of joint damage in RA. And this number is increasing each year. Hawks agrees. There is a lot of room for hope, she said.

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Five pipeline agents vying for share in the rheumatoid arthritis market – pharmaceutical-technology.com

December 16th, 2020 9:51 pm

GlobalData projects that between 2019 and 2029, seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) will see the approval and launch of five new agents for the treatment of rheumatoid arthritis (RA). Agents include one GM-CSF-inhibiting biologic (GSKs otilimab), one IL-6-inhibiting biologic (R-Pharms olokizumab), one TNF-inhibiting biologic (Taishos ozoralizumab), one BTK inhibitor (Roche/Genentechs fenebrutinib), and one IRAK 4 inhibitor (Pfizers PF-06650833).

Ozoralizumab is an inhibitory anti-TNF- trivalent nanobody complex. Two nano-bodies target TNF- while one binds to human serum albumin, theoretically extending the drugs half-life and distribution in vivo. The drug is formulated for administration via subcutaneous (SC) injection every four weeks. Ozoralizumab was originally developed by Ablynx, which in early 2018, was acquired by Sanofi. Very limited efficacy and safety data are currently available for ozoralizumab, and thus, the drugs prospects as a sixth-to-market TNF inhibitor in Japan remain uncertain. Olokizumab is a humanised interleukin-6 (IL-6) monoclonal antibody (mAb) that acts by blocking the final assembly of IL-6 to its signalling complex.

Phase IIb clinical development targeted patients who had unsuccessful responses to anti-TNF therapy. In H2 2020, R-Pharm announced positive topline results from CREDO 2 and CREDO 3, stating that all primary and secondary endpoints were achieved and that both once per month and twice per month dosing regimens were superior to placebo and non-inferior to adalimumab. There are currently two other IL-6 inhibitors, Roche/Genentech/Chugais Actemra/RoActemra (tocilizumab) and Sanofi/Regeneron/Asahi Kaseis Kevzara (sarilumab). Otilimab is a fully human monoclonal antibody (IgG1) directed against granulocyte-macrophage colony-stimulating factor (GM-CSF) that is in Phase III development by GSK. GM-CSF is a cytokine that drives the activation and proliferation of multiple innate immune cell types and is implicated in a wide range of auto-immune diseases. KOLs were relatively enthusiastic about otilimab, particularly in the context of it being a novel MOA that could provide another option to patients who are TNF inhibitor refractory.

Finally, there are two kinase inhibitors, fenebrutinib, a small-molecule inhibitor of Brutons tyrosine kinase (BTK) in development by Roche/Genentech, and PF-06650833, a highly selective, reversible, small-molecule inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4) in development by Pfizer. Both of these agents would be small-molecule, oral therapies, which are in high need for rheumatoid arthritis due to the significant costs associated with biologics, currently dominate the market. KOLs were intrigued by these new mechanisms of action (MOAs) but believed the drugs would be most effective as part of combination therapy with TNF or JAK inhibitors.

Figure 1 outlines the key Phase III/Phase IIb trials for these promising late-stage pipeline agents.

Figure 1: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for RA in the 8MM During the Forecast Period, 20192029

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Chi Arthritis & Rheumatology able to see more patients and support new E/M coding using mobile AI voice assistant from Saykara – Business Wire

December 16th, 2020 9:51 pm

SEATTLE--(BUSINESS WIRE)--Having used a multitude of traditional modalities for clinical charting, including transcription services and in-person scribes, Dr. Jasen Chi was determined to find the holy grail he envisioned. Chi wanted to enter the exam room, confer with a patient in-depth, and exit knowing the SOAP note would be quickly and accurately generated based on what was said, with structured and narrative data populated directly to the electronic health record (EHR). He recently discovered that very solution with Saykara and is now seeing more patients and enjoying better, more robust documentation as a result.

Saykara is a Seattle-based health tech startup using artificial intelligence (AI) to free physicians from administrative burdens. The companys proprietary platform applies deep machine learning and long-form natural language understanding to write notes, orders, referrals and more by ambiently listening to conversations between physicians and patients.

One of the most important things the healthcare community can do to improve access to care and drive costs down is make sure physicians are consistently performing at the top of their license, says Shawn Studdard, CEO and practice director of Chi Arthritis & Rheumatology. Saddling physicians with tasks like documentation creates barriers and time constraints that our nations healthcare system needs to overcome. Adopting technology like the Saykara mobile AI voice assistant is a big step forward toward resolving this problem.

Chi Arthritis & Rheumatology is known for diagnosing difficult autoimmune conditions, protecting joints from long-term erosions and deformities, and offering aggressive treatments and plans for improved quality of life. Founder, Dr. Jasen Chi, considers the exam room a sacred space for patients and family members, and refuses to allow computer data entry during visits. I want patients to feel like they are receiving our undivided attention with no distractions, says Chi. We dont want anything standing in the way of our ability to connect with patients and earn their trust.

By using the Saykara mobile AI voice assistant, Chi is now able to see approximately 15% more new patients a week. He has completely eliminated after-hours charting and dramatically reduced the overall amount of time spent charting. SOAP notes are populated directly to the EHR, requiring only his review and signoff.

Like all physician practices, Chi Arthritis & Rheumatology is faced with conforming to the 2021 evaluation and management (E/M) coding changes. Studdard feels that by using the Saykara mobile AI voice assistant, they are aptly positioned to support the updated medical decision making (MDM) criteria. Using the Saykara mobile AI voice assistant has increased the quality and comprehensiveness of our SOAP notes, which I believe will allow us to more than adequately satisfy the level of documentation needed for new E/M coding, says Studdard. I also believe that having audio files of everything said during physician-patient visits is ideal for addressing claims-related matters that may arise, such as audits, denials or downcoding.

Access to audio files captured by Saykara also aids the orientation and education of Chi Arthritis & Rheumatologys advanced practice nurses. Having our advanced practice nurses listen to visits with complex patients is a very useful teaching tool, says Studdard. The Saykara mobile AI voice assistant is definitely helping us maximize productivity and efficiency, and with our fifth location opening soon, this is more important than ever.

About SaykaraSaykara has developed a platform that uses artificial intelligence (AI) to interpret conversations between physicians and patients, transform salient content into clinical notes, orders, referrals and more, then populate both structured and narrative data directly to electronic health record systems. This is accomplished through a voice-enabled assistant named Kara that physicians access via a mobile app. The platform is specialty agnostic, scalable across any size enterprise and available with a software-as-a-service (SaaS) subscription. It has been proven to completely eliminate after-hours charting, reduce overall time spent charting by up to 70%, and enhance documentation quality and completeness by an average of 20%. Plus, with no need for computer data entry during visits, it gives physicians more face time with their patients and fosters more personalized interactions. For additional information, visit http://www.saykara.com.

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The global autoinjectors market is projected to reach USD 104.9 billion by 2025 from USD 46.0 billion in 2020, at a CAGR of 17.9% from 2020 to 2025 -…

December 16th, 2020 9:51 pm

New York, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Autoinjectors Market by Therapy, Type, Route of administration, End User - Global Forecast to 2025" - https://www.reportlinker.com/p05482959/?utm_source=GNW The patent expiry of biologics is also expected to provide growth opportunities for players in the market.On the other hand, the preference for alternative routes of drug delivery such as oral diabetic agents and nasal epinephrine sprays is expected to limit the adoption of autoinjector devices.

The rheumatoid arthritis segment accounted for the largest share of the autoinjectors market in 2020Based on therapy, the autoinjectors market is segmented into rheumatoid arthritis, multiple sclerosis, anaphylaxis, diabetes, and other therapies (cardiovascular diseases, migraine treatment, anemia, and progesterone therapy).In 2019, rheumatoid arthritis accounted for the largest market share of autoinjectors market.

The large share of this segment is mainly due to the high prevalence of rheumatoid arthritis.

The subcutaneous segment is projected to grow at the highest CAGR during the forecast periodBased on route of administration, the autoinjectors market is segmented into intramuscular and subcutaneous.Patients use autoinjectors for intramuscular and subcutaneous administration of various drugs for the treatment of diseases such as rheumatoid arthritis, multiple sclerosis, anaphylaxis, diabetes, migraine, anemia, and cancer.

The subcutaneous segment is projected to grow at the highest CAGR during the forecast period. The highest CAGR of this segment can primarily be attributed to the growing number of product approvals by regulatory bodies for the treatment of chronic diseases.

North America accounted for the largest share of the autoinjectors market in 2020.The autoinjectors market is segmented into five major regions, namely, Europe, North America, the Asia Pacific, Latin America, and the Middle East & Africa.North America was the largest regional market for autoinjectors.

Growth in the North American market is majorly driven by factors such as the rising incidence of anaphylaxis and the presence of favorable reimbursements.Moreover, the US and Canada are developed economies with high awareness and adoption rates for advanced devices such as autoinjectors, which is beneficial for market growth.

Furthermore, other microeconomic indicators such as rising healthcare expenditures, high affordability rate, and the improving regulatory scenario are also major factors contributing to market growth. By Company: Tier 1: 40%, Tier 2: 35%, and Tier 3: 25% By Designation: C-level Executives: 25%, Directors: 55%, and Others: 20% By Region: North America: 40%, Europe: 25%, APAC: 20%, LATAM: 10% and MEA: 5%

Some of the key players in the autoinjectors market are AbbVie Inc. (US), Mylan (US), Eli Lilly and Company (US), Ypsomed (Switzerland), Amgen (US), Becton, Dickinson and Company (US), GlaxoSmithKline plc (UK), Johnson & Johnson (US), Teva Pharmaceutical (Israel), Antares Pharma (US), Merck KGaA (Germany), Meridian Medical Technologies, Inc. (US), Roche Diagnostics (Switzerland), Bespak (UK), Bayer (Germany), SHL Medical (Switzerland), Haselmeier (Switzerland), Owen Mumford (UK), Ravimed (Poland), Medeca Pharma AB (Sweden), Cambridge Consultants Ltd. (UK), Flex (US), SMC Ltd. (US), and Promius Pharma (US). The study includes an in-depth competitive analysis of these key players in the autoinjectors market, along with their company profiles, recent developments, and key market strategies.

Research Coverage:The market study covers the autoinjectors market across various segments.It aims at estimating the market size and the growth potential of this market across different segments by therapy, type, route of administration, end users and region.

The study also includes an in-depth competitive analysis of the key players in the market, along with their company profiles, key observations related to their product and business offerings, recent developments, and key market strategies.

Key Benefits of Buying the Report:The report will help market leaders/new entrants in this market and provide information regarding the closest approximations of the autoinjectors market and its subsegments.This report will help stakeholders understand the competitive landscape, gain insights to position their businesses better, and plan suitable go-to-market strategies.

The report will also help stakeholders understand the pulse of the market and provide information on key market drivers, restraints, opportunities and challenges.

Read the full report: https://www.reportlinker.com/p05482959/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The global autoinjectors market is projected to reach USD 104.9 billion by 2025 from USD 46.0 billion in 2020, at a CAGR of 17.9% from 2020 to 2025 -...

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Intraarticular Injection of Infliximab-Loaded Thermosensitive Hydrogel Alleviates Pain and Protects Cartilage in Rheumatoid Arthritis – DocWire News

December 16th, 2020 9:51 pm

Purpose:Pain and cartilage destruction caused by rheumatoid arthritis (RA) are major challenges during clinical treatment. Traditional systemic administration not only has obvious side effects but also provides limited relief for local symptoms in major joints. Local delivery of therapeutics for RA treatment is a potential strategy but is limited by rapid intraarticular release.

Materials and methods:In this study, we prepared a thermoresponsive injectable hydrogel by mixing pluronic F127 (F127) and hyaluronic acid (HA) with poly (-glutamic acid) (PGA) incorporating infliximab (IFX), a new generation monoclonal antibody drug. We investigated the biocompatibility of the hydrogel and its IFX release profile. In vivo, we studied the clinical manifestations (articular skin temperature and joint diameter), detected cytokines in the synovial fluid and cartilage, performed behavioral studies on pain relief, and evaluated the cartilage protection effect.

Results:A thermoresponsive hydrogel was successfully prepared by mixing F127, HA, and PGA with injectable properties. The F127-HA-PGA hydrogel had a porous structure with interconnected pores. The infliximab-loaded thermosensitive hydrogel exhibited good biocompatibility and biodegradability and sustained release properties. Intraarticular injection of the IFX-loaded F127-HA-PGA hydrogel could alleviate the expression of inflammatory cytokines, such as tumor necrosis factor- (TNF-), interleukin-1 (IL-1), interleukin-6 (IL-6), and interleukin-17 (IL-17), in the synovial fluid and cartilage as well as relieve pain and inhibit cartilage destruction in RA.

Conclusion:The double effect on pain relief and cartilage protection indicated the significant potential of the IFX-loaded injectable hydrogel for RA treatment in major joint lesions.

Keywords:control release; hydrogel; infliximab; intraarticular injection; rheumatoid arthritis.

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Intraarticular Injection of Infliximab-Loaded Thermosensitive Hydrogel Alleviates Pain and Protects Cartilage in Rheumatoid Arthritis - DocWire News

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Cyxone has filed an IND in the US with Rabeximod following positive feed-back from pre-IND meeting with the FDA – BioSpace

December 16th, 2020 9:51 pm

STOCKHOLM, Dec. 15, 2020 /PRNewswire/ -- Cyxone (publ.), a clinical stage biotech company developing first-in-class drugs for diseases of the immune system, announced today that the company has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) pertaining to its drug candidate Rabeximod. The application follows on a productive pre-IND meeting with the authority, where valuable advice was received on inter alia the protocol for its imminent European Phase 2 clinical study in moderate Covid-19. The IND covers the development of Rabeximod in Covid-19 and other indications, such as rheumatoid arthritis, and is a prerequisite for a future validation of the company's five recent patent applications in the US market.

Cyxone recently held a constructive pre-IND meeting (type B meeting) with the FDA, and the authority's advice has been incorporated in the study protocol for the clinical study of Rabeximod in Covid-19, which is expected to be initiated shortly in Europe. The filing of an IND will enable participation of US medical centers in future clinical studies of Rabeximod in Covid-19, rheumatoid arthritis and potential other indications. The IND package is based upon the favorable safety profile of Rabeximod shown in previous Phase 1 and Phase 2a studies. In Covid-19, Rabeximod is positioned as an oral treatment of moderately diseased patients - a group that is not addressed by current standard of care therapeutics.

"Filing an IND with the FDA is an important step in the clinical development of Rabeximod. It is a quality stamp on our drug candidate and Covid-19 trial and would enable us to expand the clinical development to the United States. Even as vaccines are becoming available, safe and convenient treatments for Covid-19 will be required to lower the death toll of the current global health emergency and to be better prepared for future pandemics", said Cyxone's CEO, Tara Heitner.

Cyxone recently announced that the company had received regulatory approval to initiate a randomized, placebo controlled, double blind, Phase 2 clinical trial of Rabeximod in Poland. In parallel, the company has submitted a Clinical Trial Application in Slovakia and is preparing for submissions in additional countries. Rabeximod will be evaluated in patients suffering from moderate Covid-19 in need of oxygen treatment but not ventilation support. In the study, 300 patients will receive Rabeximod orally at one of two dose levels or placebo for 14 days after which Cyxone will evaluate the study outcome. Cyxone aims to announce top-line results from the study in the third quarter of 2021.

"We look forward to initiating the Phase 2 study in Covid-19 patients as soon as possible, to provide important information about the safety and efficacy of Rabeximod in an acute setting", said Cyxone's Chief Operating Officer, Malin Berthold.

Contact

Tara Heitner, CEOTel: +46 70 781 88 08Email: tara.heitner@cyxone.comAdelgatan 21211 22 Malm, Sweden

This contains such information that Cyxone AB is required to make public under the EU's Market Abuse Regulation. The information was provided under the auspices of the above contact person for publication on 15 December 2020 at 09.25 CET.

About Cyxone

Cyxone AB (publ) (Nasdaq First North Growth Market: CYXO) develops disease modifying therapies for diseases such as rheumatoid arthritis and multiple sclerosis as well as treatments for virally induced acute respiratory disorders. Rabeximod is a Phase 2 candidate drug being evaluated for the management of rheumatoid arthritis and moderate Covid-19 infections. T20K is a Phase 1 candidate drug for treatment of multiple sclerosis. Certified Adviser is Mangold Fondkommission AB, +46 (0)8 503 015 50, ca@mangold.se. For more information, please visit http://www.cyxone.com

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/cyxone/r/cyxone-has-filed-an-ind-in-the-us-with-rabeximod-following-positive-feed-back-from-pre-ind-meeting-w,c3254848

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SOURCE Cyxone

Company Codes: ISIN:SE0007815428, Stockholm:CYXO

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Cyxone has filed an IND in the US with Rabeximod following positive feed-back from pre-IND meeting with the FDA - BioSpace

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Incidence, risk factors and validation of the RABBIT score for serious infections in a cohort of 1557 patients with rheumatoid arthritis – DocWire…

December 16th, 2020 9:51 pm

Objectives:Predicting serious infections (SI) in patients with rheumatoid arthritis (RA) is crucial for the implementation of appropriate preventive measures. Here we aimed to identify risk factors for SI and to validate the RA Observation of Biologic Therapy (RABBIT) risk score in real-life settings.

Methods:A multi-centre, prospective, RA cohort study in Greece. Demographics, disease characteristics, treatments and comorbidities were documented at first evaluation and one year later. The incidence of SI was recorded and compared with the expected SI rate using the RABBIT risk score.

Results:A total of 1557 RA patients were included. During follow-up, 38 SI were recorded [incidence rate ratio (IRR): 2.3/100 patient-years]. Patients who developed SI had longer disease duration, higher HAQ at first evaluation and were more likely to have a history of previous SI, chronic lung disease, cardiovascular disease and chronic kidney disease. By multivariate analysis, longer disease duration (IRR: 1.05; 95% CI: 1.005, 1.1), history of previous SI (IRR: 4.15; 95% CI: 1.7, 10.1), diabetes (IRR: 2.55; 95% CI: 1.06, 6.14), chronic lung disease (IRR: 3.14; 95% CI: 1.35, 7.27) and daily prednisolone dose 10 mg (IRR: 4.77; 95% CI: 1.47, 15.5) were independent risk factors for SI. Using the RABBIT risk score in 1359 patients, the expected SI incidence rate was 1.71/100 patient-years, not different from the observed (1.91/100 patient-years; P = 0.97).

Conclusion:In this large real-life, prospective study of RA patients, the incidence of SI was 2.3/100 patient-years. Longer disease duration, history of previous SI, comorbidities and high glucocorticoid dose were independently associated with SI. The RABBIT score accurately predicted SI in our cohort.

Keywords:comorbidities; glucocorticoids; infections; rheumatoid arthritis; risk score.

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Further genetic clues to severe COVID-19 – PHG Foundation

December 16th, 2020 1:57 am

New research published in Nature has revealed important genetic causes of the most severe forms of COVID-19 disease.

Researchers studied over 2,000 severely ill patients with COVID-19, and compared their genomes to those of healthy people from existing population studies in the UK. They found that patients were much more likely to possess variations in a small number of genes that affect anti-viral immune responses and inflammation information that suggests existing drugs could be useful treatments for severe disease.

COVID-19 has been known for almost a year now, but the variation in effects on different people remains baffling: some experience no discernible symptoms at all, others a mild or moderate illness, and some a very distinct, severe and life-threatening illness. Although certain clear risk factors have emerged for the most dangerous forms of the disease, notably older age and certain conditions such as heart disease, diabetes and severe obesity, both within and outside these groups, SARS-CoV-2 infection causes a bewildering and unpredictable range of responses.

Understanding precisely who is and is not at greater risk of dangerous forms of the disease would play a very important role in ongoing efforts to control the disease and prevent the worst effects. It would allow preventative efforts including new vaccines to be directed first towards those at greatest risk. It also offers important clues to the underlying mechanisms that drive the most severe forms of disease, and hence to potential treatments.

It has seemed likely from the beginning that genetic variation between different people accounts for some of the otherwise inexplicable variation in disease severity. It may also account for differing disease susceptibility how likely someone is to become infected; this is the case for many other infectious diseases, though it is less obvious to see and hence to study. Doctors and scientists around the world have thrown themselves into efforts to uncover the genomic factors driving severe disease.

This new paper used DNA samples from over 2,200 patients with severe COVID-19 treated in over 200 intensive care units were obtained from to major research initiatives, the GenOMICC (Genetics Of Mortality In Critical Care) and the ISARIC Coronavirus Clinical Characterisation Consortium 4C studies. Genome sequences were compared with healthy control subject genomes from the UK Biobank to identify areas of the genome where there were significant differences. Findings were checked against samples from a similar number of hospitalised cases from the COVID-19 Host Genetics Initiative.

A handful of important genes involved in severe COVID-19 were identified, of two main types. The first group were genes involved in antiviral defences; the OAS gene helps block replication and spread of the virus, whilst IFNAR2 is involved in the production of an important immune mediator, interferon, which helps to trigger immune responses to viral infections. Weak early responses to infection could help the SARS-CoV-2 virus to spread and grow in the patient.

These discoveries are in line with earlier findings that pinpointed genetic changes that impaired interferon function among severe COVID-19 patients. Whilst giving interferon to critically ill patients has not proved very effective, there is hope that early administration to people with genetic predisposition to poor interferon responses who are infected by the virus might prevent severe disease.

The second group of genes implicated in severe COVID-19 were likely to play a role in the dangerous inflammatory lung damage seen in patients in critical care. These included rare variants in the TYK2, DPP9 and CCR2 genes. TYK2 is involved in controlling immune response; a rare variant that causes excessive inflammation was common among patients. This is a positive finding, since there are already anti-inflammatory drugs that target this particular biological pathway, and could prove to be valuable new treatments. Both DPP9 and CCR2 are also involved in different aspects of inflammatory responses to infection.

The researchers expect that there are other genes that affect the risk of severe disease, and hope to uncover more of these in due course as they analyse genomes additional patients; rarer genetic changes are harder to find and require larger numbers of people in studies. They are particularly interested in additional genetic factors that might account for the increased risk of severe disease seen in certain ethnic groups.

Meanwhile, other researchers continue to employ genome sequencing of the virus itself, rather than human hosts, to aid the battle against COVID-19. The UK government recently announced an additional 12.2 million funding for the COVID-19 Genomics UK (COG-UK) Consortium to continue and expand viral genome sequencing. Combining this information with patient data helps to identify whether the virus is becoming more or less infectious, or dangerous, or amenable to new vaccines all vital information.

Tackling COVID-19 without the insights provided by genomics would be infinitely more difficult like trying to understand the virus and the disease blindfolded and would undoubtedly have hugely slowed the development of vaccines, treatments and other responses to limit the harm caused by the pandemic.

Take a look at our short animation on pandemic in the genomic era

Link:
Further genetic clues to severe COVID-19 - PHG Foundation

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Is Height Genetic? Why and Why Not? – Healthline

December 16th, 2020 1:57 am

Humans come in a variety of heights and genetics play a key role in determining whether you will be short or tall.

Theres much more than just heredity to consider before assuming a person will automatically be the same height as their parents. Medical conditions, hormonal deficiencies, and more can all contribute to how tall you are.

Read on to learn about all of the components that contribute to a persons natural height.

Genetics are among the prominent factors that contribute to how tall youll be.

As a general rule of thumb, your height can be predicted based on how tall your parents are. If they are tall or short, then your own height is said to end up somewhere based on the average heights between your two parents.

Genes arent the sole predictor of a persons height. In some instances, a child might be much taller than their parents and other relatives. Or, perhaps, they may be much shorter.

Such key differences may be explained by other factors outside of your genes that contribute to height.

Aside from genetics, there are other factors to consider that can determine a persons height, especially during childhood and adolescence.

While eating more vegetables wont automatically make you taller, getting adequate nutrition during your growing years is critical in human development, including your height.

A diet based on whole, nutritious foods can ensure you will grow up to the height your genes might dictate. On the flip side, a poor diet could lead to a shorter stature compared to your parents.

Eating healthy isnt so simple for all families. Children of a poor socioeconomic status may be at risk of a lack of access to nutrition, along with poor access to adequate health care. This, in turn, can contribute to a shorter height.

You may notice that boys grow slower than girls at first, due to differences in puberty milestones. Overall though, adult males tend to be an average of 14 centimeters (5.5 inches) taller compared to adult females.

During puberty, hormones are essential for regulating body growth. These include thyroid hormones, human growth hormones, and sex hormones such as testosterone and estrogen.

Any abnormalities in these hormones could alter growth as well as your overall height. Children who develop hypothyroidism (low thyroid) or pituitary gland disorders may experience shorter than average height compared to their parents.

Rarely, hormonal disorders can contribute to being taller than normal. For example, gigantism is caused by too many human growth hormones produced by pituitary gland tumors.

Some conditions present at birth may dictate a persons height. For example, achondroplasia (dwarfism) is a rare bone growth disorder that runs in families.

Another congenital disorder that can cause short stature is known as Turner syndrome. This rare condition causes delays in puberty. Unlike achondroplasia, Turner syndrome doesnt run in families.

Other congenital disorders lead to a taller than normal stature. These include Marfan and Klinefelter syndromes.

Marfan syndrome is caused by connective tissue enlargements, while Klinefelter syndrome occurs when males are born with an additional copy of the X chromosome.

Overall, theres no way you can increase your height. Each person is born with genes that will help dictate how tall they become, but other factors such as inadequate nutrition or medical conditions may alter this outlook.

Hormonal conditions may be the few exceptions. If a lack of thyroid or human growth hormones is detected during childhood, then taking medications may help reverse the effects on height.

However, once you reach adulthood, taking hormonal replacements wont make you taller. At this point, your full height has already been achieved, and taking any medications or supplements wont make a difference.

Its important to focus on good nutrition during childhood, but sticking with these habits will also contribute to your overall health into adulthood and beyond regardless of your height.

Poor posture and lack of exercise can also contribute to poor stature, so correcting these items may help increase your height (or the appearance of it).

Its widely regarded that your genes will dictate how tall you become. However, there are other exceptions to this rule, including your gender, access to nutrition, and any underlying medical or congenital conditions you may have.

See a doctor if you have any concerns about your height, or if you have a child who isnt reaching their growth milestones. They can discuss nutritional issues with you, and they may help rule out the possibility of any hormonal issues.

Continue reading here:
Is Height Genetic? Why and Why Not? - Healthline

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Holocaust survivor, geneticist, patient advocate remembered for inspiring others – University of Wisconsin-Madison

December 16th, 2020 1:57 am

A dedicated University of WisconsinMadison clinician, educator, advocate and researcher, Renata Laxova, professor emerita of medical genetics and pediatrics, passed away recently after a brief illness. She was 89.

Laxovas lifelong interests focused on the causes of intellectual and developmental disabilities, prenatal diagnosis of genetic disorders and birth defects, cancer genetics, and above all the relationships between medical professionals and the patients and families they serve. She was especially interested in coping strategies for families in difficult situations.

Renata Laxova

Laxova obtained MD and PhD degrees from the University Medical School in Brno, in what is now the Czech Republic. Initially trained in pediatrics, she later specialized in medical genetics at University College and Guys Hospital in London. She came to the United States in 1975 and joined the UWMadison departments of Pediatrics and Medical Genetics, where she served until she retired in 2000.

A skilled educator, Laxova loved teaching and stressed the importance of making clinical care personal. Understanding that genetics could be an extremely complicated discipline, Laxova worked to build awareness and accessibility through education and experiences. She underscored the importance of the patient perspective and was one of the first on campus to invite parents and families to share with her students their experiences caring for children with genetic conditions or disabilities.

David Wargowski, a clinical geneticist in the Waisman Center Medical Genetic Clinic a clinic and program Laxova helped build says Laxova inspired him to pursue a career in genetics. He first met Laxova as a medical student at UWMadison.

I found human genetics fascinating in college and was excited to have an opportunity to learn about how it applied to the medical care of people with genetic conditions, Wargowski says.

In the mid-1980s, medical genetics was still a field which primarily addressed rare disorders that were off the radar of most physicians.I learned about many of those, but more important to my medical training was learning from Laxovas example that being a good doctor is about more than being knowledgeable. It also means being compassionate and devoted to patients.

Patient care was primary for Laxova. Her innate ability to make connections with patients and learn their story set her apart. She is remembered for asking families during clinical visits, How can we most help you? a sentiment that embodied her commitment to patient advocacy and care that also led to her work on resources and supports for families throughout the state.

Responding to concern that many genetic disorders were going unnoticed and undiagnosed, Laxova helped establish the Genetic Contact Network. Within the network, professionals throughout the state identify people in need of genetic counseling and make referrals. These efforts led to the corresponding Genetic Services Network of outreach clinics and Laxova was a driving force behind the service sites in Green Bay, La Crosse and Eau Claire, among others.

At the Waisman Center, Laxova was in charge of the medical genetics program and clinic program and all of its elements clinical, education and research long before there was a program director, says Wargowski.

In 1976, Laxova was also instrumental in establishing the masters in genetic counseling training program with founding director Joan Burns. The training program was among the first of its kind in the United States and Laxova served as its first medical director, a position she held for more than 20 years. During that time, she helped train hundreds of genetic counselors while treating patients and their families in the Waisman Medical Genetics Clinic.

Casey Reiser, director of the Genetic Counselor Training Program, was herself a student in the third class of genetic counselors. Like Wargowski, Reiser had the opportunity to work with Laxova both as a student and colleague.

She was always animated and enthusiastic when she shared her knowledge with students, says Reiser. Renata was an inspiration, a wonderful mentor, and a beloved friend. She will be missed by many.

While known for the successes of her career, Laxova is also remembered for her experiences escaping both the Holocaust and communism. Laxova twice fled her homeland of the Czech Republic (then known as Czechoslovakia). In the days leading up to World War II, she escaped from the Nazis through safe passage to Britain on the last Kindertransport, which rescued thousands of children from the Holocaust. She returned in 1946.

In the late 1960s, married to her husband Tibor, and as a young mother, doctor and researcher, she once again made her way to Britain to avoid the encroaching Russian communist regime. The couple later moved to Wisconsin, where Tibor, a veterinarian, opened a practice. She joined the faculty of UWMadison in 1975. Her lifes story is chronicled in a poignant memoir dedicated to her grandson titled Letter to Alexander.

Wargowski describes the sentiment felt by many who knew and worked with Laxova.

If you didnt know her, Im sorry you didnt have that chance, he says. She was a remarkably gracious person with an amazing life story. She was absolutely devoted to her patients, her craft and her colleagues, especially those who asked for the opportunity to learn from her. She was a remarkably compassionate person and physician who taught more than genetics. She practiced a love for her patients to which most of us can only aspire, and an intolerance of disparity and discrimination that challenges the most motivated among us.

University Archives has two oral interviews with Renata Laxova from 2004 and 2008. You can access them here: https://search.library.wisc.edu/digital/AMGNC3S2LPJZPN83

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Holocaust survivor, geneticist, patient advocate remembered for inspiring others - University of Wisconsin-Madison

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