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Monday, August 2, 2021

Could BTK Inhibitors Be the Next Big MS Treatment?

 by Ed Tobias | July 30, 2021  - The MS Wire

Is orelabrutinib one of the next big MS therapies? Biogen is betting at least $125 million that it is.

Orelabrutinib is an experimental oral BTK inhibitor (BTKi). BTKi’s are designed to selectively block an enzyme that’s important for the activation of B-cells and microglia. Some of those immune cells drive the abnormal immune responses that characterize MS. Researchers hope the medication will lower inflammation and slow progression of all forms of MS, as Multiple Sclerosis News Today‘s Marta Figueiredo noted.

Orelabrutinib was developed as a cancer drug, but it began a Phase 2 clinical trial in March to judge its safety and efficacy as a treatment for relapsing-remitting MS. Biogen has bought the rights to globally distribute the medication as an MS drug. According to a Biogen press release, if certain development and sales goals are met, Biogen will pay up to an additional $812.5 million to InnoCare Pharma, the Chinese company that developed the medication, plus royalties.

Other BTKi tests underway

Orelabrutinib isn’t the only BTK inhibitor in the research pipeline. Sanofi has tolebrutinib (previously known as SAR442168), Roche is studying fenebrutinib, and EMD Serono (Merck KGaA outside North America) is investigating evobrutinib. All are in Phase 3 trials.

Small and selective

The big deal about BTK inhibitors seems to be that they can selectively target B-cells, wiping out those that harm the immune systems of people with MS while leaving normal B-cells alone. (Disease-modifying therapies such as Ocrevus (ocrelizumab) and rituximab wipe out all of the B-cells, leaving a greater chance of infection.)

“That’s important. That’s what you want,” Peggy Kendall, an allergist and immunologist at Washington University School of Medicine, told the journal Nature Biotechnology.

BTK inhibitors are small molecules. According to University of California, San Francisco neurologist Stephen Hauser, also quoted in Nature Biotechnology, this fact allows them to get into parts of the nervous system that other antibodies have a tough time reaching.

Hauser even used the “C-word,” telling the journal’s Elie Dolgin that if small-molecule therapies can “knock out the adaptive inflammation that’s overactive in the nervous system, I think we can really cure MS.”

Could that really be true?

That’s a pretty powerful prediction. No wonder several pharmaceutical companies have their research eyes on BTK inhibitors and are willing to pay big bucks to carve out a piece of this pie. I’m not a scientist or a doctor, so I can’t judge whether or not “we can really cure” is just hyperbole. But let’s hope that working with BKTi’s at least leads us in that direction, and that the cost of developing them won’t push their price tag into the stratosphere.

About the Author

Ed Tobias Diagnosed with MS at age 32 in 1980, Ed has written the "MS Wire" column for Multiple Sclerosis News Today since August 2016. He presents timely information on MS, blended with personal experiences. Before retiring from full-time work in 2012, Tobias spent more than four decades in broadcast and on-line newsrooms as a manager, reporter, and radio news anchor. He’s won several national broadcast awards. As an MS patient communicator, Ed consults with healthcare and social media companies. He’s the author of “We’re Not Drunk, We Have MS: A tool kit for people living with multiple sclerosis.” Ed and his wife split time between the Washington, D.C. suburbs and Florida’s Gulf Coast.







Saturday, July 31, 2021

Gilenya Started Earlier in RRMS Disease Course in Recent Years

 By Marisa Wexler MS on Jul 26, 2021

People with relapsing-remitting multiple sclerosis (RRMS) have switched to treatment with Gilenya (fingolimod) at an earlier stage in their disease in recent years, compared to individuals who switched to the treatment around the time it became available, a new study indicates.

The findings suggest “an increased experience in using fingolimod [Gilenya] for sub-optimally treated RRMS patients and a change in mindset towards an early treatment optimization to improve long-term outcome,” the researchers wrote.

The study, “The Change of Fingolimod Patient Profiles over Time: A Descriptive Analysis of Two Non-Interventional Studies PANGAEA and PANGAEA 2.0,” was published in the Journal of Personalized Medicine. It was funded by Novartis, which markets Gilenya (though generics have also become available in recent years).

Gilenya became the first oral medication approved to treat RRMS in 2011. In the decade since it became available, the landscape of MS treatment has changed dramatically.

In the new study, researchers in Germany conducted a descriptive analysis of two observational clinical trials, called PANGAEA and PANGAEA 2.0. These trials aimed to assess the real-world usage of Gilenya among MS patients in Germany.

In total, the team assessed data from 3,188 patients who were enrolled in PANGAEA from 2011–2013, and for 2,441 patients enrolled in PANGAEA 2.0 from 2015–2019. All patients had not been treated with Gilenya prior to enrolling.

The mean patient age was similar in both studies: 38.8 for PANGAEA and 39.2 for PANGAEA 2.0. The latter trial had a higher proportion of patients under age 30 (25.2% vs. 23.1% in the earlier trial) and of patients over age 50 (16.9% vs. 12%), whereas PANGAEA enrolled more participants between 30 and 50 years old (64.9% vs. 57.9%).

Prior to enrolling in the trial, over 90% of participants in PANGAEA 2.0 had been previously treated with glatiramer acetate (Copaxone and generics), Tysabri (natalizumab), or beta interferons (which include AvonexBetaseronExtaviaPlegridy, and Rebif). By contrast, only about half of participants in PANGAEA had been on these medications before starting in the trial.

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Friday, July 30, 2021

Swimming gives your brain a boost – but scientists don’t know yet why it’s better than other aerobic activities

 by:   - Assistant Professor of Biology, University of Mary Hardin-Baylor     

Swimming offers a host of beneficial effects on the brain. Stanislaw Pytel/Stone via Getty Images

It’s no secret that aerobic exercise can help stave off some of the ravages of aging. But a growing body of research suggests that swimming might provide a unique boost to brain health.

Regular swimming has been shown to improve memory, cognitive function, immune response and mood. Swimming may also help repair damage from stress and forge new neural connections in the brain.

But scientists are still trying to unravel how and why swimming, in particular, produces these brain-enhancing effects.

As a neurobiologist trained in brain physiology, a fitness enthusiast and a mom, I spend hours at the local pool during the summer. It’s not unusual to see children gleefully splashing and swimming while their parents sunbathe at a distance – and I’ve been one of those parents observing from the poolside plenty of times. But if more adults recognized the cognitive and mental health benefits of swimming, they might be more inclined to jump in the pool alongside their kids.

New and improved brain cells and connections

Until the 1960s, scientists believed that the number of neurons and synaptic connections in the human brain were finite and that, once damaged, these brain cells could not be replaced. But that idea was debunked as researchers began to see ample evidence for the birth of neurons, or neurogenesis, in adult brains of humans and other animals.

Now, there is clear evidence that aerobic exercise can contribute to neurogenesis and play a key role in helping to reverse or repair damage to neurons and their connections in both mammals and fish.

Research shows that one of the key ways these changes occur in response to exercise is through increased levels of a protein called brain-derived neurotrophic factor. The neural plasticity, or ability of the brain to change, that this protein stimulates has been shown to boost cognitive function, including learning and memory







At-home Tysabri Infusions Appear as Safe, Effective as Those at Clinics

 by Forest Ray PhD | 

Tysabri (natalizumab) infusions given in the home to people with relapsing-remitting multiple sclerosis (RRMS) save money and are more convenient, while apparently as safe and effective as those given in clinical settings, a pilot study comparing the two delivery methods reported.

Nonetheless, its researchers recommended larger trials be conducted to verify these findings, particularly in managing side effects due to drug hypersensitivity while at home.

The study, “Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial,” was published in the Annals of Clinical and Translational Neurology.

At-home infusion therapy has grown since it first started in the 1970s, the study noted, following a global trend in providing more healthcare in community settings rather than hospitals.

Among the medicines now being tested for at-home administration is Tysabri, used to limit damage to the myelin sheath that insulate neurons in people with relapsing forms of MS.

The Biogen medication, usually given as an hour-long intravenous infusion in a clinical setting under doctor supervision, prevents inflammatory immune cells from entering the brain and spinal cord. These cells mistakenly attack and degrade myelin in MS.

A subcutaneous, or under-the-skin formulation, is available in Europe but not in the United States.

To test Tysabri’s eligibility for at-home delivery, Australian researchers enrolled 35 adults with RRMS in a clinical trial to assess whether home administration was safe, feasible, acceptable to patients and healthcare workers, efficient at treating symptoms, and cost-effective.

Participants, who were using Tysabri for five years on average, were randomized to usual care or at-home infusions. Each patient underwent three monthly infusions in one of those settings, then switched to the other setting for three more infusions.

Investigators compared safety outcomes, adherence to therapy, patient satisfaction, quality of life, disability, and costs between the two delivery approaches.

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Thursday, July 29, 2021

MS MENTAL WELLNESS CHAT: Communication & Relationships - Building your Emotional Support Team






Why Does Marijuana Affect Me Differently Than Other People?

 Written by: Amy B. Gragnolati, PharmD, BCPS - a clinical pharmacist in San Francisco, California

  • The effects of marijuana can vary from person to person, depending on genetics, age, gender, and the quantity and strength of the marijuana.
  • Is marijuana harmful or helpful? It’s complicated.
  • It’s likely that marijuana can be positive or negative, depending on the situation and person.

What is marijuana and how does it work in the body?

When we talk about marijuana, we are referring to the part of the cannabis plant that contains large amounts of THC. THC is a cannabinoid — an active chemical in marijuana — that can alter your mind and make you feel “high.”

Why can marijuana make you feel this way? THC resembles a naturally occurring chemical in the body called anandamide. Because THC can “trick” the brain into thinking it is anandamide, it can affect areas of the brain responsible for controlling: 

  • Memory
  • Thinking
  • Concentration
  • Pleasure
  • Movement
  • Coordination

The effects you might feel are not always the same as what someone else might feel.

What is the difference between recreational and medical cannabis?

Medical cannabis is a term used to describe the use of cannabis for treating certain health conditions. Recreational use is when you use marijuana for personal enjoyment rather than treating an illness. On a federal level, all marijuana is illegal. However, many state governments have legalized medical marijuana, and some have legalized recreational use as well.

What is CBD and how is it different from THC? 

Watch this video presentation on Bladder issues and Pelvic Floor

Bladder issues, discussion on pelvic floor and bladder exercises in MS, 

Presented by Carina Siracusa, PT, DPT, WCS

Begins at: 32:05 into this video

Watch all or advance the scroll-bar to the mentioned timeframe

Is Medicare Part C (Advantage) or Medicare Part D Better For You?

 written by: - Beth Braverman, for GoodRx  -  July 23, 2021

Key takeaways:

  • To get prescription drugs via Medicare, you’ll need either a Medicare Part C (Medicare Advantage) or Part D policy.
  • Part C and Part D policies are provided only by private insurers.
  • In choosing between Part C and Part D, consider whether you want coverage for other types of medical care and if you have other insurance that covers prescription drugs.

If you’re on Medicare, there are two ways that you can get outpatient drug coverage. You can choose a stand-alone Part D plan to go along with your Original Medicare Parts A and B. Or you can enroll in a Medicare Advantage (MA) plan, also known as Medicare Part C, that includes prescription drug benefits (MAPD). 

Given the cost of prescription drugs, it’s worth considering this coverage even if at present you don’t spend much on your medications. Understanding how Medicare drug coverage works can help you make an informed decision about the best plan for you

What do Medicare Part C and Part D have in common?

Medicare Parts C and D have several similarities:

  • Both are private insurance. The federal government offers Original Medicare, which includes Part A (hospital insurance) and Part B (medical insurance). By contrast, Medicare Parts C and D are approved by Medicare but offered through private insurers.
  • Both have premiums and out-of-pocket costs. In this way, Medicare Parts C and D are like most other types of health insurance.
  • Both have an open enrollment period. During their shared open enrollment period —October 15 through December 7—you can enroll in a new plan or switch plans. Medicare Advantage has an additional open enrollment period—January 1 through March 31—when you can switch to another Advantage plan.
  • Neither plan covers medications when you are outside of the United States. If you plan to travel abroad, consider getting travel insurance that will cover your drug costs.

How is Medicare Advantage different from Part D?

Medicare Part D is a supplement to Original Medicare and covers prescription drugs only. Medicare Advantage, on the other hand, replaces Original Medicare and becomes your hospital and medical insurance plan. 

In addition, Medicare Advantage plans often cover prescription drugs as well as dental, vision, and hearing care. However, people with Medicare Advantage plans are typically limited to a network of doctors that accept their insurance, while those with Original Medicare can go to any doctor that accepts Medicare (most do).

Nearly 90% of Medicare Advantage plans include Medicare Part D, but you can also purchase Part D separately if you have an Advantage plan that does not include it. About a third of Medicare beneficiaries had Medicare Advantage plans in 2019.

How do factors such as deductibles and copay levels vary between Medicare Advantage and Part D?

The amount you pay in deductibles and copays for Medicare Advantage will vary depending on the plan you choose and where you live. That said, MA plans typically cap your total out-of-pocket costs. For 2021, the cap averages just over $5,000 for in-network services and about $9,200 for out-of-network services, according to the Kaiser Family Foundation

Copayments for Medicare Part D plans are a bit more complicated. You’ll typically owe coinsurance or copayments for drugs until you’ve reached your plan’s deductible. After the deductible—once you and the plan have spent a combined $4,130—you’ll pay just 25% of the cost of your drugs until you reach the out-of-pocket maximum of $6,550.

Medicare Part D premiums vary significantly depending on where you live. An analysis by Kaiser Family Foundation found that premiums ranged from less than $6 per month in Hawaii to more than $200 per month in South Carolina.

Is the appeal process the same for Part C and Part D?


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