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Friday, March 29, 2019

“Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis”

Patients who are diagnosed with Relapsing Multiple Sclerosis may qualify for a new study titled “Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis”.

The study’s objective is to assess the safety and effectiveness of the study medication in reducing the number of new active brain lesions reported with Magnetic Resonance Imaging (MRI) with patients with Relapsing MS.

Inclusion Criteria :

  The participant must be aged between 18 to 55 years of age and have been diagnosed with Relapsing Multiple Sclerosis.
  The participant must have at least 1 documented relapse within the previous year, ≥2 documented relapses within the previous 2 years, or ≥1 active Gd- enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.

Exclusion Criteria :

  The participant has been diagnosed with Primary-Progressive MS (PPMS) or with non-relapsing Secondary-Progressive MS (SPMS)
  The participant has an EDSS score >5.5 at the first screening visit
  The participant has had a relapse in the 30 days prior to randomization

Study medication:
The study   medication   belongs   to   a   class   of   medicines   called   Bruton's   tyrosine kinase inhibitors (BTKi), which can reduce the activity of the BTK enzyme in cells from the body's immune system.
BTK is a molecule involved   in   the development of B cells and microglia, which can be involved in the disease process of MS. By reducing the B cells and microglia activation, this may decrease   inflammation   in   the brain.
The proposed mechanism of action for the study medication is to prevent  the  formation  of new brain lesions in MS.
The study medication will be administered orally (by mouth) as a tablet.

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What Is Secondary Progressive Multiple Sclerosis?

March 28, 2019

If your doctor says you have secondary progressive multiple sclerosis (SPMS), it means you're in a different stage of your disease. Most folks get it after living for a while with relapsing-remitting MS (RRMS).

In SPMS, you may not get any break in your symptoms, unlike RRMS, when you had flare-ups that came and went. But your doctor can suggest medicine to help manage them.

Secondary vs. Relapsing-Remitting MS

About 85% of people with MS start with the relapsing-remitting form. They get attacks of symptoms called relapses, followed by symptom-free periods called remissions.
During relapses, your immune system -- your body's defense against germs -- causes inflammation that damages the protective coating around nerve fibers. This disrupts the flow of nerve signals to and from the brain and spinal cord. It leads to symptoms like tiredness, numbness, and weakness.
Then the immune system stops attacking. Your symptoms improve or disappear, and you go into remission. Relapses and remissions alternate over time.
In SPMS, your symptoms steadily get worse instead of coming and going. You might still have relapses, but they don't happen as often.

What Causes SPMS?

It's not clear exactly why RRMS changes to SPMS. Some researchers think it happens because of nerve damage that occurred earlier in the disease.
Not everyone with the relapsing-remitting form of the disease will get SPMS. Doctors don't know for sure who will and who won't, and how quickly it will happen.
You're more likely to change to SPMS if:
  • You're older
  • You've lived with MS for a long time
  • You have a lot of nerve damage in your brain and spinal cord
  • You have frequent and severe relapses

When Do People Change to SPMS?

A small number of people start out with SPMS. They may have had RRMS first, but it wasn't diagnosed or their symptoms were too mild to notice.
Before disease-modifying drugs were available, half of people with RRMS changed to SPMS within 10 years.
New treatments have altered the course of MS. Today these drugs can slow MS and delay the move towards SPMS, although doctors don't know how much they delay it.

What to Expect


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Los síntomas de la esclerosis múltiple


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Thursday, March 28, 2019

Spasticity in Multiple Sclerosis (MS)

Spasticity is a very common symptom of MS. There are two types of MS-related spasms: flexor and extensor. Flexor spasticity is an involuntary bending of the hips or knees (primarily involving the hamstring muscles on the back of the upper leg). The hips and knees bend up toward the chest. Extensor spasticity is an involuntary straightening of the legs. Extensor spasticity involves the quadriceps (muscles on the front of the upper leg) and the adductors (inner thigh muscles). The hips and knees remain straight with the legs very close together or crossed over at the ankles. Spasticity may also occur in the arms, but is less common in people with MS.
Spasticity may worsen due to sudden movements or position changes, muscle tightness, temperature extremes, humidity or infections. It may even be triggered by tight clothing.
Spasticity may be as mild as the feeling of tightness in muscles or may be severe enough to produce painful, uncontrollable spasms of the extremities; most commonly the legs and arms. Spasticity may also create feelings of pain or tightness in and around joints and can cause low back pain.
Adverse effects of spasticity include:
  • Muscle stiffness, causing movements to be less precise and making certain tasks difficult to perform
  • Muscle spasms, causing uncontrollable and often painful muscle contractions
  • Involuntary crossing of the legs
  • Muscle and joint deformities
  • Muscle fatigue
  • Inhibition of longitudinal muscle growth
  • Inhibition of protein synthesis in muscle cells
Additional complications
  • Urinary tract infections
  • Chronic constipation
  • Fever or other systemic illnesses
  • Pressure sores
There are several types of treatment available that must be evaluated on a case-by-case basis, depending on the underlying cause, age of the patient and severity of the spasticity. Different treatments share the common goals of:
  • Relieving the signs and symptoms of spasticity
  • Reducing the pain and frequency of muscle contractions
  • Improving gait, hygiene, activities of daily living and ease of care
  • Reducing caregiver challenges such as dressing, feeding, transport and bathing
  • Improving voluntary motor functions involving objects such as reaching for, grasping, moving and releasing
  • Enabling more normal muscle growth in children
Physical and occupational therapy for spasticity is designed to reduce muscle tone, maintain or improve range of motion and mobility, increase strength and coordination and improve comfort. Therapy may include stretching and strengthening exercises, temporary braces or casts, limb positioning, application of cold packs, electrical stimulation and biofeedback.
The use of oral medications to treat spasticity may be indicated when symptoms interfere with daily functioning or with sleep. Effective medication management may require the use of two or more drugs or a combination of oral medications with another type of treatment. It is very important to work closely with a doctor to devise an individualized treatment plan. Side effects vary greatly by class of medication and patient.
Medications include:
  • Baclofen
  • Benzodiazepines
  • Dantrolene sodium
  • Imidazolines
  • Gabapentin
BTA, also known as Botox injections, when used in tiny amounts, have proven effective in paralyzing spastic muscles. Injection sites are carefully determined based on the pattern of spasticity.
When Botox is injected into the muscle(s), the release of acetylcholine is blocked, resulting in a relaxation of overactive muscles. The injection(s) generally take effect within a few days and last about 12-16 weeks, until new nerve endings grow back and the affected muscle(s) recover. Functional benefits may last longer than this. There are limitations in the number of injections that can be administered.


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Local patients with multiple sclerosis using LEGO therapy

LOUISVILLE, Ky. (WDRB) -- LEGOs might be the colorful bricks of your childhood, but for one group of multiple sclerosis patients, they're therapy.
Norton Healthcare is hosting a trial class to see to see how it's helping patients both mentally and physically.
Tucked away in a room at Norton Women's and Children's Hospital, about a dozen people are building something special using colorful bricks as therapy for people suffering from multiple sclerosis.             
"Happy therapy," said Tiny Jones who was diagnosed in 2011.
The tiny pieces are making a big difference.
"I could feel it actually rewiring my brain," said Kathleen Jordan who got the idea when she found a giant bag of LEGOs at a thrift store. The LEGOs helped her at a time when she needed it most.
"Unfortunately, I'd lost a really close friend, my sister and my dog all within six months. So it was a pretty dark time for me. I didn't really want to do anything. Kind of closed in," said Jordan.
She'd never done LEGOs before, but she started to sort by shape and color to pass the time. As she did, she noticed a change. "It started improving my spirit and making me feel better," Jordan said.
She figured if it helped her, it might help other people who suffer from multiple sclerosis. She brought the idea to the therapists at the Norton Neuroscience Institute who decided to start a trial class.
"We decided it was worth trying. It was worth seeing if this was a good idea to help patients with MS," said Amber Brennan, an occupational therapist with Norton Neuroscience Institute.
The resource center offers lots of different therapies for those with MS, but never LEGOs.
"I know there's other LEGO therapy groups with children, but this is the first I've known with adults," said Brennan.
It launched at the beginning of the year, with about a dozen participants meeting every Tuesday to build. The class keeps their hands moving and their minds sharp. With MS, it can be tough to recognize patterns or follow instructions. Working with LEGOs isn't just about tapping into their inner child, they're also challenging their brains and fine motor functions.
"It's been amazing to see how much we're able to challenge everybody little by little each week," said Brennan.
Therapists assessed the abilities of the patients at the beginning of the trial, and after 10 weeks, will look at how they're changing both physically and mentally.
"I feel tremendously that we will be able to notice very objective and measurable gains just by what I've seen in the sessions," said Brennan. "People who needed lots of help in the beginning don't need that much help at all now."
The Neuroscience Institute is in the process of applying for grants to offer the class throughout the year, not just for people with MS, but those with other neurological disorders too.
"It's another tool in the tool box," said Brennan.

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ICER does a disservice to people living with multiple sclerosis

MP4MS                                 PRESS RELEASE
FOR IMMEDIATE RELEASE           March 28, 2019
Media inquiries: Daniel Kantor, MD (904)687-7879 or

ICER does a disservice to people living with multiple sclerosis

Coconut Creek, Fl. – Recently, a self-appointed non-governmental organization with various industry backings, the Institute for Clinical and Economic Review (ICER) released a premature, flawed draft evidence report on Novartis's Mayzent® (siponimod) for the treatment of SPMS, which much like ICER's 2017 report on disease-modifying therapies for multiple sclerosis, was not truly patient-centric and largely ignored comments by the patient MS community (and even quoted a focus group of three patients). Instead of comparing siponimod to other MS DMTs FDA-approved for relapsing forms of MS, it compared siponimod to "best supportive care" (i.e. no disease modifying treatment at all). Even the other DMTs discussed in the draft report do not include many of those already used (and approved by the FDA) for the treatment of active SPMS (such as, fingolimod, teriflunomide, dimethyl fumarate and alemtuzumab).

"People living with MS face many potential challenges," according to Dr. Daniel Kantor, Founder and President of the Medical Partnership 4 MS (MP4MS), "but fending off inaccurate reports written by organizations with unclear backing, shouldn't be one of them." As the largest physician and allied healthcare professional organization comprised of those interested in caring for people with MS (as opposed to large MS centers), MP4MS appreciates and congratulates the
U.S. FDA for clarifying the definition of relapsing forms of MS. Unlike ICER, MP4MS accepts no industry financial support.

Dr. Bhupendra Khatri, an active member of MP4MS and an MS specialist from Milwaukee, WI said that "the self-appointed Institute for Clinical and Economic Review (ICER) is once again doing a disservice to people living with chronic medical conditions by not fully researching or vetting its (even draft) evidence reports." On page 16 of ICER's draft report, under the section Summary of Coverage Policies and Clinical Guidelines, it states that "we were unable to identify any NCDs or LCDs relating to the use of DMTs for MS." Unfortunately, ICER has once again (originally, prior to being corrected by organizations actually knowledgeable about MS, ICER incorrectly referred to RRMS as "remitting-relapsing multiple sclerosis") demonstrated its naiveté regarding MS since Wisconsin Physicians Service Insurance Corporation L34741, does in fact include multiple sclerosis in the coverage determination of one of the intravenous medications, natalizumab.

Futhermore, ICER's estimation of the monitoring costs of the first dose observation (FDO) of a higher risk cardiac group of siponimod patients woefully underestimates the true costs associated with such monitoring. "Instead of calculating the cost of FDO, ICER ignores the healthcare costs of monitoring a patient for 6 hours, and simply inputs the cost of a follow-up office visit and two electrocardiograms," said Dr. David Brandes an MS specialist and MP4MS member in Knoxville, TN. "People with MS deserve better, and MP4MS calls upon the entire MS community to stand up to outside influences attempting to limit access to care, " said Dr. Kantor.

About the Medical Partnership 4 MS (MP4MS):

The Medical Partnership 4 MS (MP4MS) is committed to advocating for multiple sclerosis (MS) patients in the southern United States by engaging the varied stakeholders, and by returning health care to the core values of a strong and united patient-doctor relationship. As the largest advocacy group on behalf of providers of MS care, the MP4MS is composed of over 1,300 neurologists and allied health professionals dedicated to the treatment and management of patients with MS, and remains independent by not accepting financial support from the pharmaceutical or insurance industries.

About Neurology Benefit Management, LLC
Neurology Benefit Management, LLC increases quality of neurological care and reduces costs by aiding healthcare professionals and payors in the appropriate evidence-based management of patients with neurological conditions.

About Multiple Sclerosis (MS):
Multiple Sclerosis (MS) is the most common acquired disabling neurologic disease of the young. Most people are diagnosed in their twenties to forties, and live life with a relapsing-remitting form of this demyelinating autoimmune disease, and many of them transition to secondary-progressive MS, with disability progression between relapses or even in the absence of relapses.

Newer estimates of the prevalence of MS are that there are close 1,000,000 people living with MS in the U.S. today.

Article Provided by:  #MSViewsandNews

Wednesday, March 27, 2019

Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease.

Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease. This was also approved for RRMS and CIS (Clinically Isolated Syndrome) -

- Mayzent® (siponimod) is the first and only oral treatment specifically indicated for active secondary progressive multiple sclerosis (SPMS) in adults
- Up to 80% of patients with relapsing remitting MS (RRMS) will develop SPMS(1); Mayzent addresses a critical unmet need for RRMS patients in transition and those with active SPMS who have transitioned
- Approval is based on the Phase III EXPAND trial, the largest controlled clinical study of SPMS patients, showing Mayzent significantly reduced the risk of three-month confirmed disability progression in patients with active disease(2)
- Mayzent is approved across the MS spectrum for clinically isolated syndrome (CIS), RRMS and active SPMS, with most patients not requiring a first dose observation


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Tuesday, March 26, 2019

Advancing MS: Coping with Depression, Stress, and Anger

Multiple sclerosis (MS) can profoundly affect your physical health, but it can also take a serious toll on your mental health. Depression, stress, anxiety, and mood swings are all common in people with advancing MS, but it’s possible to manage these emotional changes. Here are some ways to reduce stress, create a healthier mindset, and maintain a better quality of life.

If you have MS, you know that each day brings new challenges and questions. Constant uncertainty and worry can cause almost anyone to feel anxious, stressed, or fearful.
According to the Cleveland Clinic, the most common emotional changes you may experience with MS include:

Your experience of the disease may lead to depression. For example, your changing body and mind may affect how you feel about yourself and your life. The disease itself may also cause depression: As MS attacks the myelin, your nerves may no longer be able to correctly transmit the electrical impulses that affect your mood.
The good news is that depression can be treated. In most cases, doctors prescribe a combination of therapy and antidepressant medication. Talk therapy may be one-on-one with a licensed professional, or your doctor may suggest meeting in group therapy sessions with other people who also have MS.

Stress can be healthy in small doses. It promotes faster responses to situations which require them and can even boost immunity.
Prolonged and unresolved stress can have the opposite effect, however. You may begin having new or worsened MS symptoms because of how stress affects the disease and your body.
MS is unpredictable, which can add to stress. The disease can change and get worse without warning. Other stressful factors include the invisibility of symptoms, financial concerns about covering treatment, and the constant adjustments needed to address the progressing disease.
Stress can be treated, though. In fact, a 2012 study found that people with MS who followed an 8-week stress management program of relaxation breathing and muscle relaxation techniques experienced less stress and fewer symptoms of depression.
Regular exercise can also help reduce stress. Talk with your doctor or physical therapist about ways you can be active without aggravating your symptoms or setting back progress.


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What is the Modified Fatigue Impact Scale?

The Modified Fatigue Impact Scale (MFIS) is a tool that doctors use to evaluate how fatigueaffects someone’s life.
Fatigue is a common and often frustrating symptom for up to 80 percent of people with multiple sclerosis (MS). Some people with MS find it hard to accurately describe their MS-related fatigue to their doctor. Others have difficulty communicating the full effect that fatigue has on their daily life.
The MFIS involves answering or evaluating a series of questions or statements about your physical, cognitive, and psychosocial health. It’s a quick process that can go a long way toward helping your doctor fully understand how fatigue affects you. This makes it easier to come up with an effective plan for managing it.
Read on to learn more about the MFIS, including the questions it covers and how it’s scored.

The MFIS is generally presented as a 21-item questionnaire, but there’s also a 5-question version. Most people fill it out on their own in a doctor’s office. Expect to spend anywhere from five to ten minutes circling your answers.
If you have vision problems or trouble writing, ask to go through the questionnaire orally. Your doctor or someone else in the office can read off the questions and note your answers. Don’t hesitate to ask for clarification if you don’t fully understand any of the questions.

Simply saying you’re fatigued usually doesn’t convey the reality of how you’re feeling. That’s why the MFIS questionnaire addresses several aspects of your daily life to paint a more complete picture.
Some of the statements focus on physical abilities:
  • I have been clumsy and uncoordinated.
  • I have to pace myself in my physical activities.
  • I have trouble maintaining physical effort for long periods.
  • My muscles feel weak.
Some statements address cognitive matters, such as memory, concentration, and decision-making:
  • I have been forgetful.
  • I have trouble concentrating.
  • I have difficulty making decisions.
  • I have trouble finishing tasks that require thinking.
Other statements reflect psychosocial aspects of your health, which refers to your moods, feelings, relationships, and coping strategies. Examples include:
  • I have been less motivated to participate in social activities.
  • I am limited in my ability to do things away from home.
You can find the full list of questions here.
You’ll be asked to describe how strongly each statement reflects your experiences in the last four weeks. All you have to do is circle one of these options on a scale of 0 to 4:

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MS Fatigue: What to Know

Medically reviewed by Seunggu Han, MD —
Written by Jacquelyn Cafasso on March 14, 2019

While most people associate multiple sclerosis (MS) with muscle weakness, numbness, and pain, fatigue is actually the most common symptom of the condition.
Nearly 80 percent of people diagnosed with MS experience fatigue at some point, according to the Multiple Sclerosis Association of America.
Fatigue is defined as extreme tiredness or unrelenting exhaustion. The fatigue associated with MS can be difficult to cope with, and is also difficult to explain to other people. Although it’s an invisible symptom, fatigue is very real for those living with the condition.
The first step to treating fatigue is to find out what’s causing it. Fatigue may be a result of nerve damage caused by MS. Sleep problems, depression, and medication side effects could also be part of the problem.
The good news is that it’s possible to manage fatigue with the right combination of medications, lifestyle changes, and energy-saving tips.

Scientists currently don’t fully understand the exact cause of MS-related fatigue. Some think that fatigue may be related to the constant activation of the immune system, sort of like having the flu virus at all times.
Others theorize that fatigue is related to the need for the brain to work harder in people with MS.
MRI scans have shown that people with MS fatigue use a larger area of the brain to perform tasks than people without fatigue. In response to nerve damage, the brain of a person with MS may be finding new routes for sending messages. This is thought to take more energy.
The feeling of fatigue may also be a result of the muscle weakness associated with MS.
Certain complications of MS can also induce fatigue. This may be referred to as a secondary cause. Complications of MS that may also cause fatigue symptoms include:
Fatigue can also be a side effect of certain medications, such as those used to treat spasticity, pain, and bladder dysfunction.
Click here to continue reading from Healthline


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