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Friday, May 15, 2020

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Tuesday, May 12, 2020

COVID-19 May Not Be Severe in MS Patients, Early Data from Italy Suggest

 MAY 12, 2020  - BY MARTA FIGUEIREDO

People with multiple sclerosis (MS) may not be at higher risk of developing a severe COVID-19 infection, according to preliminary data from patients in Italy.
“At the moment, these results seem to be quite reassuring for most people with MS” Marco Salvetti, MD, PhD, professor at Sapienza University and Sant’Andrea Hospital, in Rome, said in a press release.
Nevertheless, the early nature of these data must be taken into account. Evidence is also still lacking to determine how the use disease-modifying therapies (DMTs), sex, or simultaneous conditions (comorbidities) affect this patient population, the researchers noted.
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Their study, “An Italian programme for COVID-19 infection in multiple sclerosis,” was published in the journal The Lancet Neurology. It was written by Maria Pia Sormani, PhD, on behalf of the Italian Study Group on COVID-19 infection in MS.
Findings come from the pilot phase of an international web platform, called MuSC-19 (Multiple Sclerosis and COVID-19), that is collecting clinical and demographic data, as well as information on DMTs, on MS patients who have symptoms and signs of COVID-19 regardless of a confirmed infection via nasal and pharyngeal swabs.
The platform, donated by Roche, became active on March 14 in Italy, among the first European countries to experience severely the effects of COVID-19. Data are collected via an electronic case report form specifically developed for this pandemic, and provided to healthcare providers.
MuSC-19 is part of a program developed by The Italian Multiple Sclerosis Society (AISM), its Foundation (FISM), and the Multiple Sclerosis Study Group of the Italian Society of Neurology. The platform is also linked to the Italian MS Register, which currently collects data on more than 60,000 people with MS in Italy.
MuSC-19’s goal is to better understand the relationship between MS and COVID-19 and how a number of factors — namely age, sex, comorbidities, and treatments — affect infection outcomes in MS patients.
Particularly unclear is whether immunosuppressive therapies — the mainstay for MS treatment — increase a person’s susceptibility to severe COVID-19 infection, or if they might protect against the exacerbated immune and inflammatory responses associated with severe complications.
Such information can help to guide treatment decisions in MS patients with COVID-19 symptoms or a confirmed diagnosis, and “implement immediate and appropriate protective strategies,” Sormani wrote.
Sormani, a professor of biostatistics at the University of Genoa, is also responsible for the management of the MuSC-19 platform.
“The platform is accessible, upon registration, to the whole scientific community interested in collecting this type of data, regardless of their nationality and willingness to participate in this or other collateral initiatives aimed to collect clinical data and biological samples,” Sormani said in the release.
To date, 78 MS clinical centers in Italy and 28 centers from 15 other counties have contributed to the MuSC-19 platform, the AISM reported.
Study data covered 232 MS patients from 38 Italian centers who, as of April 7, had tested positive for COVID-19 (57 people) or were suspected of infection (175 people). Patients’ mean age was 44; most were women (69%), had relapsing-remitting MS (88%), and were being treated with a DMT (90.9%).
DMTs most frequently used by these people were Tecfidera (dimethyl fumarate, by Biogen), 24.6%; Gilenya (fingolimod, by Novartis), 13.4%; Ocrevus (ocrelizumab, by Genentech and Roche), 11.2%; Tysabri (natalizumab, by Biogen), 10.8%; and, glatiramer acetate (Copaxone, by Teva, and Glatopa, by Sandoz), 10.3%.
The vast majority — 223 patients, 96% of the total group — had a mild infection, defined as mild or no pneumonia. The infection was severe in four people, 2%, all of whom had shortness of breath, respiratory rates of at least 30 breaths per minute, and blood-oxygen saturation levels of 93% or less. Six patients, 3%, had critical infection, defined as respiratory failure, septic shock, and multiple organ dysfunction or failure, and were hospitalized in an intensive care unit.
Most MS patients, 209 or 90.1% of all with confirmed or suspected COVID-19 cases, were not hospitalized.
Of the six critical patients, all diagnosed with the virus, one recovered and five (2%) died. Patients who died tended to have comorbidities, higher disability, and/or were age 50 or older.
Although preliminary, these data suggest that most MS patients are likely to have a mild infection, in step with the general population, and that DMT use may not raise their risk of a severe infection.
“These results appear to be slightly reassuring and do not seem to contradict guidelines that we and others had already issued on the management of multiple sclerosis treatments in the time of the COVID-19 pandemic,” Sormani wrote.
Data also support that MS patients “with comorbidity and disability combined with older age are exposed to the risk of a worse evolution of the disease … [and] therefore require special care in preventing infection,” Salvetti added.
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Monday, May 11, 2020

New model coronavirus verified by contact infection experiment on cruise ship

May 08, 2020 

In an experiment conducted by NHK in collaboration with experts on how contact infections, which are said to have led to the spread of infection on cruise ships, occur, a paint that looks like a virus spreads through what many people touch. It was confirmed. It is said that the cruise ship caused the spread of infection due to contact infection, and it is thought that it occurred at a buffet venue where many people gather.


WATCH THE VIDEO : https://bit.ly/3fI1jQ2


NHK, in collaboration with experts, conducted a verification experiment with 10 participants. In the experiment, one person was designated as an infected person, and on the assumption that the cough was suppressed by hand, a fluorescent paint that looked like a virus was applied to the palm of the hand, and the buffet was enjoyed freely for 30 minutes.

After that, when a special light was applied to check the paint that glowed pale, it was found that it spread to a wide range of dishes and hands.

It was confirmed that the paint spread to the hands of all the participants, and that the three were on the face.

It was spread through the lid of the container holding the food, the tongs separating the food, and the handle of the drink container.

On the other hand, as a measure against infection, the store clerk separates the dishes and frequently exchanges the tongs, and encourages customers to clean their hands frequently. It means that no one was attached.

Professor Hiroyuki Kunishima of St. Marianna University School of Medicine said, "A place where the unspecified majority can easily touch is called a high-touch surface, which is harboring danger.See article in full



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From The CDC : How COVID-19 Can Spread in a Community – Video

May 11, 2020
This message includes updates on the COVID-19 response from CDC. The COVID-19 Outbreak is a rapidly evolving situation and information will be updated on the COVID-19 Situation Summary as it becomes available.


This video explains how COVID-19 can spread in a community using an example featured in an April 2020 CDC MMWR. Investigation of COVID-19 cases in Chicago identified a cluster of 16 confirmed or probably cases, including three deaths, likely resulting from one introduction. Extended family gatherings, including a funeral and birthday party, likely facilitated transmission of SARS-CoV-2 in this cluster. 




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Sunday, May 10, 2020

MS Society-Supported Wellness Research Group Publishes Strategies for Improving Diet Studies in People with MS

April 27, 2020
Can a person’s diet make their MS worse or better? Is there an ideal diet for people with MS? Evidence-based answers to these and other questions require results from well-designed studies. A Wellness Research Group supported by the National MS Society has published new strategies for improving diet studies in people affected by MS, based on studies that have already been completed or are underway. These recommendations can inform studies going forward to ensure they provide the answers people and their healthcare providers need to enhance well being. See how a healthy diet, regular exercise, stress management and other wellness strategies can help you manage your symptoms and feel your best.

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  • As part of its ongoing wellness initiative, the National MS Society convened a group of researchers with experience in MS and  diet-related research, as well as a person living with MS, to develop recommendations regarding unmet needs and opportunities in diet -related research. The group’s primary mission is to promote scientific evidence to support lifestyle, behavioral, and psychosocial approaches for promoting wellness in people living with MS.
  • Based on lessons learned from recent or ongoing diet studies, the group discussed several recommendations going forward, including the following:
    • Begin dietary studies with an education session led by a nutritionist and include local options for food shopping. Include partners/significant others, to ease implementation at home. Make sure that people fully understand the dietary interventions they are being asked to follow, and what will be expected in terms of time, finances, and travel.
    • Let people who already cook be creative with the diet plan to increase flexibility, but include highly specific guidance for people who do not, to decrease anxiety.
    • Depression, anxiety, fatigue, and mobility impairments – common in the course of MS – may affect adherence and need to be considered in study design.
    • Studies may involve collecting blood, urine or stool samples, but it’s important to balance the need for samples with the fact that collecting them too frequently may deter recruitment or compliance. 
“Conducting dietary intervention trials in people with multiple sclerosis: Lessons learned and a path forward” is published by Dr. Kathryn Fitzgerald, Dr. Ellen Mowry (Johns Hopkins University, Baltimore) and colleagues in the journal MS & Related Disorders.

About Multiple Sclerosis

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New Study Links Obesity to Faster Nerve Loss in People with MS

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April 23, 2020
Johns Hopkins University researchers funded in part by the National MS Society report that people with MS who were obese experienced accelerated loss of optic nerve tissue compared to people of normal weight. The study followed 513 people with MS  for about four years. The authors suggest that, if confirmed, the findings show a link between a wellness factor – body weight -- and MS progression, and support studies that would track whether reducing weight can improve outcomes in MS.
  • Optical coherence tomography (OCT) has been increasingly used as a research tool to detect and track damage that occurs to the nerves in the back of the eye. OCT scanning is done with a small machine that can fit into an examining room, is relatively inexpensive, painless and well tolerated.
  • This team has previously shown that the rate of tissue thinning seen on OCT in people with MS over time reliably mirrors overall brain health and nerve loss, suggesting that OCT can show underlying disease progression.
  • In this study, loss of tissue in a specific nerve layer in the back of the eye, called the ganglion cell and inner plexiform layer, was accelerated in people who were obese at the start of the study (defined as having a body mass index of 30 or higher).
  • This study adds important evidence to previous findings that obesity worsens outcomes for people with MS. Understanding further the relation between obesity and nervous system health may also have implications for people with other health concerns.
  • Obesity is considered a modifiable risk factor – learn more about healthy eating and taking control of your weight. Get information on food planning during the coronavirus pandemic from the U.S. Department of Agriculture.
“Association of body mass index with longitudinal rates of retinal atrophy in multiple sclerosis” by Drs. Angeliki G Filippatou, Shiv Saidha and colleagues (The Johns Hopkins University School of Medicine, Baltimore, MD) was published on April 16, 2020 in the Multiple Sclerosis Journal.

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FDA Approves Bafiertam, (a Tecfidera) Generic, for Relapsing MS



Banner Life Sciences Announces Final FDA Approval of BAFIERTAM for Multiple Sclerosis

BAFIERTAM™ (monomethyl fumarate), the bioequivalent alternative to Biogen’s Tecfidera® (dimethyl fumarate), is a new oral treatment option for relapsing forms of multiple sclerosis
Open path to commercialization

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April 30, 2020 07:05 AM Eastern Daylight Time

HIGH POINT, N.C.--(BUSINESS WIRE)--Banner Life Sciences LLC (Banner), a privately held specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) granted final approval of BAFIERTAM™ (monomethyl fumarate) delayed-release capsules for the treatment of relapsing forms of multiple sclerosis (MS).

“The FDA’s final approval marks an important milestone for Banner and for patients living with relapsing-remitting multiple sclerosis,” said Franck Rousseau, M.D., Chief Executive Officer of Banner. “We are working diligently and are eager to bring this alternative treatment to physicians and patients as soon as possible.”

“As a practicing neurologist treating patients with MS, I’m encouraged that a lower dose of BAFIERTAM is equivalent to Tecfidera and may possibly lead to improved gastrointestinal tolerability for patients, especially early in the treatment regimen,” said Daniel Wynn, M.D. FACNS FAASM, Director, Clinical Research, Director Consultants in Neurology Multiple Sclerosis Comprehensive Care Center, Chicago, Illinois.

The FDA granted tentative approval of BAFIERTAM on November 16, 2018 under a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. BAFIERTAM, a novel fumarate bioequivalent alternative to a prodrug of BAFIERTAM, Tecfidera®1 (dimethyl fumarate) of Biogen Inc, met the required bioequivalence, safety, efficacy and quality standards for tentative approval. Final approval was pending the expiration of U.S. Patent Number 7,619,001 (“the ‘001 patent”) on June 20, 2020 protecting Biogen’s Tecfidera, or the outcome of pending litigation between Banner and Biogen regarding the patent.

In January 2019, Banner announced that the U.S. District Court for the District of Delaware had ruled in favor of Banner’s motion for judgment on the pleadings against Biogen, Inc. deciding BAFIERTAM does not infringe the ‘001 patent, thus permitting Banner to seek final FDA approval. On April 21, 2020, Banner announced that the United States Court of Appeals for the Federal Circuit had upheld the earlier Court’s decision.

About BAFIERTAM™ (monomethyl fumarate)

BAFIERTAM is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

About Relapsing-Remitting Multiple Sclerosis

Relapsing-remitting multiple sclerosis (RRMS), the most common form of MS, is a debilitating autoimmune disease characterized by inflammatory attacks to the central nervous system followed by periods of remission. RRMS affects approximately 85 percent of patients diagnosed with MS, or an estimated 2 million people worldwide.2 There is no cure for MS and disease progression and degree of impairment vary widely by patient depending on the location and extent of nerve damage. Treatment regimens for RRMS focus on symptom management, slowing disease progression and reducing relapses.

SELECTED SAFETY INFORMATION

CONTRAINDICATIONS

BAFIERTAM is contraindicated in patients with known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM.

WARNINGS AND PRECAUTIONS

Anaphylaxis and Angioedema - BAFIERTAM can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (the prodrug of BAFIERTAM) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue BAFIERTAM and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema.

Progressive Multifocal Leukoencephalopathy - Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (the prodrug of BAFIERTAM).
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3 Techniques to Help You Overcome Anxiety and Stress

05.05.20 - BY JESSIE ACE - MultipleSclerosisNewsToday
Anxiety and stress are unhelpful for anyone’s mind or body, particularly with a chronic illness like multiple sclerosis
Feeling anxious or stressed is our brain’s mechanism to prepare the body for a potentially harmful threat. The brain releases a surge of chemicals to prepare the body for going into what’s called a fight-or-flight response. This response is meant to save our life when we are in danger.  

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However, most of the time, we’re not actually in physical danger. Rather, the danger is perceived. So how do we override this response by the brain and reduce anxiety? We must change our way of thinking and our physiology. 
What effect does anxiety have on our bodies? The released chemicals change our physiology. Blood vessels tighten, our heart pumps faster, and breathing is shallower, to name a few. 

How does anxiety affect someone with MS? Stress makes our bodies work harder, increasing fatigue and exacerbating other symptoms. 
Here’s how we hack our brain to avoid this:
  1. Question whether the thing you’re anxious about is in your control. Most often, we don’t have control over the things that are worrying us.
I know that when I was a newly diagnosed 22-year-old with MS, I used to worry like crazy about the future and what my life would be like with this illness. 
Did worrying about my future at the time help? Nope! Did it make my anxious state almost unbearable? Yep. 
The only thing you can control are the actions you take today to create a better tomorrow.
That is why it is so important to do things like getting in the routine of a healthy diet for MS and exercising today so you can be healthier tomorrow. 
Here is a video I made to help explain what I mean: https://mmini.me/areweincontrol 
  1. Use a breathing technique to override the brain’s fight-or-flight response. Breathing is super important for relaxing the body and cutting down those chemicals released by the brain. Breathing deeply sends more oxygen to the brain via the bloodstream. It pretty much tells your mind to calm down and chill out. 
Also, if you find yourself too anxious to sleep or you are struggling with insomnia, this is a great technique to try. 
Here is a video I made to explain more: https://mmini.me/Breathing
  1. Reduce anxiety by naming five things around you. This is simple but effective. Why the heck does it work? Because it focuses your brain on what’s happening in the present. Naming the things around you also changes what’s going on in your brain. The left side of your brain, which is responsible for logic and reasoning, gets drowned out by the right side, which is the imaginative, creative, and emotional side. 
In essence, naming the things around you drives focus to the left side of your brain and cancels out the imaginative/emotional response that can run away with us and create scenarios in our minds of things that might happen.
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