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Friday, September 13, 2019

Genentech Presents New Six-Year Ocrevus (Ocrelizumab) Data Which Showed That Earlier Initiation and Continuation of Treatment Reduced Disability Progression in Multiple Sclerosis

– Post-hoc analysis from a Phase III open-label extension study showed a 42% reduction in the risk of PPMS patients needing a wheelchair after six and a half years of Ocrevus treatment compared with patients who started Ocrevus after the double-blind period –
– Interim analysis of Phase IIIb study shows 87% of patients with suboptimal response to previous treatment had no evidence of disease activity one year after switching to Ocrevus –
– Separate analysis from same study showed greater patient satisfaction with Ocrevus after one year on treatment –
– More than 120,000 people have been treated with Ocrevus globally, in clinical trial and real-world settings; data continue to show a consistent and favorable benefit-risk profile –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today longer-term data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO showed that patients who were treated with Ocrevus® (ocrelizumab) continuously for six years or more had reduced risk of disability progression in relapsing MS (RMS) and primary progressive MS (PPMS). These results suggest earlier treatment with Ocrevus reduced the risk of disability progression and this effect was sustained over time. Additionally, new safety data as of January 2019 were announced, representing 4,611 patients with RMS and PPMS and 14,329 patient years of exposure to Ocrevus, across all Ocrevus clinical trials, and remain consistent with the medicine’s favorable benefit-risk profile. Findings were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm.
“The effect of MS therapies on progression – not just relapses – is very important to help reduce the impact of the disease on the daily lives of people with MS and their families,” said Professor Gavin Giovannoni, Consultant Neurologist at Barts and the London School of Medicine and Dentistry. “The Ocrevus data at ECTRIMS highlight that the benefit of delaying, and possibly preventing, disability progression is greater when the treatment is used earlier in the disease course for both relapsing and primary progressive forms of MS. These data support the aphorism, ‘time really is brain and spinal cord in multiple sclerosis.'”
In the OPERA OLE, the proportion of RMS patients with 24-week confirmed disability progression (CDP) was lower for those treated with continuous Ocrevus (total of six years on Ocrevus) compared with patients who switched to Ocrevus after two years of interferon beta-1a treatment in the double-blind period (total of four years on Ocrevus) (19% vs. 24%; p<0.05).
In the ORATORIO OLE, the proportion of PPMS patients with 24-week CDP was lower for those treated with continuous Ocrevus over six and a half years compared with patients who switched to Ocrevus from placebo after the double-blind period (52% vs. 65%; p=0.002). Upper limb disability progression, measured by the nine-hole peg test (9-HPT), was significantly reduced in patients who were continuously treated with Ocrevus compared with those who switched from placebo (31% vs. 43%; p=0.004). Data also showed earlier intervention with Ocrevus resulted in a 42% reduction in the risk of PPMS patients needing a wheelchair (EDSS≥7) over 6.5 years compared with patients who started Ocrevus treatment after the double-blind period (p=0.0112).
Additionally, data from the open-label Phase IIIb CASTING study evaluating Ocrevus in patients with RRMS who had a suboptimal response to at least six months of treatment with one or two other disease-modifying treatments (DMTs) were presented. An interim analysis showed 87% of patients who switched to Ocrevus had no evidence of disease activity (NEDA) after 48 weeks of treatment.
A new, separate analysis from the same study showed that patients who switched from another DMT to Ocrevus reported greater satisfaction with Ocrevus after one year of treatment. Patients reported satisfaction with its effectiveness, side effects, convenience and overall satisfaction, as measured by the self‐reported Treatment Satisfaction Questionnaire for Medication vII (TSQM vII).
Furthermore, results from two Phase IIIb studies, the CHORDS substudy in RRMS and the SaROD study in PPMS and RMS, demonstrate patients treated with Ocrevus at a reduced infusion time showed no increased risk of serious, severe or life-threatening infusion-related reactions. The current infusion time is approximately 3.5 hours and a majority of the patients in these studies completed infusions within 2.5 hours. Frequency of administration is highly important to patients and their healthcare providers and potentially shorter Ocrevus infusion times once every six months may improve the overall treatment experience.


Thursday, September 12, 2019

Genentech’s Satralizumab Significantly Reduced Relapse Risk in Second Positive Phase III Study for Neuromyelitis Optica Spectrum Disorder

Pivotal Phase III SAkuraStar study shows 55% reduction in the risk of relapse for satralizumab monotherapy versus placebo presented at ECTRIMS Congress 2019

74% reduction in the risk of relapse for satralizumab monotherapy versus placebo in people with neuromyelitis optica spectrum disorder (NMOSD) with aquaporin-4 antibodies (AQP4-IgG seropositive patients) Satralizumab demonstrated a similar safety profile compared to placebo in two Phase III studies across a broad population Satralizumab targets the interleukin-6 (IL-6) receptor, a key driver of NMOSD

South San Francisco, CA -- September 11, 2019 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today full pivotal Phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease. Results from the SAkuraStar study, presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), show that satralizumab monotherapy achieved a 55% reduction in the risk of relapses compared to placebo in the overall population, representative of NMOSD patients (Hazard Ratio [HR]=0.45, 95% Confidence Interval [CI]: 0.23-0.89; p=0.0184). In the large (~67%) subgroup of patients seropositive for AQP4-IgG antibodies, the effect was higher with a 74% reduction in risk of relapses (HR=0.26, 95% CI: 0.11-0.63; p=0.0014). People who are AQP4-IgG seropositive tend to experience a more severe disease course.
“The positive Phase III results for satralizumab, first as an add-on therapy and now as a monotherapy, are exciting to see, and importantly, satralizumab achieved efficacy in a broad range of NMOSD patients, reflective of what we see in our everyday practice. Satralizumab targets the IL-6 receptor, potentially offering a novel treatment approach,” said Professor Jeffrey Bennett, University of Colorado Neurology & Ophthalmology. “Approved treatment options demonstrating favorable safety and efficacy in controlled clinical trials are urgently needed. Even one relapse may lead to blindness and debilitating motor dysfunction for people with NMOSD.”


This Article is Provided by:  #MSViewsandNews

Wednesday, September 11, 2019

Music Therapy for MS: How Rhythm Can Help With Movement and Memory

Music and rhythm can improve the brain’s ability to function and the body’s ability to move.
By David Spero, RN
Medically Reviewed by Samuel Mackenzie, MD, PhD

Have you found yourself clumsier or less coordinated since you developed multiple sclerosis (MS)? Is your walking affected?

One approach that may give you your rhythm back is music therapy — a type of therapy that uses music to address physical, emotional, cognitive, or social needs of individuals.

How can music help with MS? Barbara Seebacher, PhD, a physiotherapist based in Innsbruck, Austria, explains:

“There are three different brain centers responsible for the timing of movement: the motor cortex, the basal ganglia, and the cerebellum. One or another of these can be damaged by stroke, Parkinson’s disease, or multiple sclerosis.”

Music can often supply the timing that has been damaged, helping your body to work more smoothly.

Neurological music therapist Brian Harris, a founder of MedRhythms in Boston, says, “When you hear a rhythm, a song, or a metronome, it activates the auditory system, which activates the motor system at a subconscious level.”

This process is called “entrainment.” Harris says, “The rhythm is telling your brain to tell your body to move. For people who have damage to the brain, using rhythm can engage undamaged areas to help people move. We have quantifiable data on this. People walk faster; they have longer strides. You can see the changes on neurological imaging.”
Read on

This Article is Provided by:  #MSViewsandNews

Monday, September 9, 2019

How MS Affects Sleep Quality - Plus: Sleep Tips for People with Multiple Sclerosis

Article originally published on Mattress Advisor

Do you ever feel like your energy levels disappear during the day? If so, you’re not alone. One of the hardest parts of living with Multiple Sclerosis (MS) is fatigue.
MS fatigue is unique. Instead of the typical “tired” feeling that the general population might feel when they didn’t sleep much, MS fatigue is more all-encompassing. While daytime sleepiness is usually part of it, you might also experience:
·       Brain fog
·       Trouble thinking
·       Confusion
·       Physical weakness
·       Memory difficulties
While researchers once thought it was mainly disease progression, a recent study has found that there are other factors that are stronger predictors…and one of them is the presence of sleep disturbances.
Sleep and MS have a complicated relationship. When you have MS, it can be harder to sleep. On the flip side, when you don’t sleep well, your MS symptoms can be more severe.

With 50% of people with MS reporting sleep disturbances, understanding how sleep and MS relate is the first step towards reducing MS fatigue. Read on to learn more about how MS and sleep interact and what you can do to take back control.
How MS Affects Sleep Quality
Multiple Sclerosis can have a negative impact on sleep quality. As the disease progresses, there are many changes that can cause sleep disturbances. These include:
1.      Pain: Chronic pain can make every aspect of sleep challenging. It can make it hard to fall asleep and sleep soundly throughout the night.
2.      Medications: Some MS medications have side effects that impact sleep.
3.      Frequent urge to urinate: It’s not uncommon for MS patients to experience an increased need to urinate. During the nighttime, this can lead to waking up frequently during the night.
4.      Muscle spasticity: Muscle spasms in the arms and legs can interrupt sleep and make it hard to fall asleep.
5.      Stress: Anxiety and chronic stress can happen as patients learn to cope with disease symptoms.
6.     Depression: Depression is common in MS patients, and it can also lead to trouble sleeping.
7.      Sleep disorders: Many sleep disorders are more common in MS patients than in the general public. These are often caused by MS progression.
8.      Brain lesions: MS can lead to brain lesions in regions that impact sleep.
9.     Poor temperature regulation: Some patients can experience difficulties regulating temperature. As our sleep/wake cycle is tied to body temperature changes, this can lead to insomnia.
10.  Poor sleep schedule: Daytime napping is often necessary to fight fatigue, but too much napping can make sleeping during the nighttime difficult.
As MS progresses, nerves aren’t able to communicate as well with one another. Body processes like hormone and neurotransmitter release can be impacted, resulting in many of the above sleep disturbance contributors.
Does Sleep Deprivation Make MS Worse?
In MS patients, sleep problems and symptom severity are tied. Unfortunately, not getting enough sleep can exacerbate MS symptoms. This is particularly true of daytime fatigue, which is very common in MS patients and whose primary causes are believed to be depression and sleep disturbances.
Sleep Tips for People with Multiple Sclerosis
Getting enough sleep is critical to improving symptoms like fatigue, depression, memory difficulties, stress, and more. While getting quality sleep can be a challenge with MS, there are many things that you can do to improve your quantity and quality of sleep.
Relax Before Bed
After a challenging day, it can be hard to turn off our thoughts and worries and fall asleep. Rather than worrying about tomorrow or stressing about what happened today, do what you can to calm your mind and let go of your stress.
Some great options include meditation or breathing exercises. Both of these have been shown to help reduce stress and lessen the amount of time that it takes to fall asleep.
Stop Drinking Before Bedtime
Waking up in the middle of the night because you need to run to the bathroom can be frustrating…particularly if you find falling asleep afterward difficult. If you find yourself running to the bathroom in the middle of the night, you might want to stop drinking for two hours or more before bedtime.
Set a Sleep Schedule
It can be helpful to go to bed at the same time every day. This bedtime routine helps to keep your body’s internal clock, known as its circadian rhythm, functioning properly. Additionally, try to go to sleep when it’s dark out and wake up around sunrise or a little after to avoid future sleep issues.  
Exercise During the Day, But Not at Night
Moderate exercise on a daily basis can help you sleep better while helping your mood and health. One thing to note: exercise shortly before bed can make it harder to fall asleep. Avoid working out three hours or more before bedtime.
Limit Alcohol and Caffeine
Both alcohol and caffeine can disrupt your natural sleep/wake cycle and make getting quality sleep hard to do. If you’re going to have caffeine, try to stop drinking it around midday. As for alcohol, the less the better. Even one or two drinks before bedtime can reduce how much deep sleep you achieve, and it can exacerbate sleep disorders like sleep apnea.
Prepare Your Room for Sleep
In order to sleep soundly throughout the night, there are a few things that you will want to take care of. First, be sure to limit distractions. This might mean having pets sleep outside of your bedroom and turning your phone to airplane mode, so you don’t get interrupted while you sleep.
Next, control the sound and light in your room. If ambient light comes through your windows, use dark curtains or blackout shades to limit it. If you find that noises wake you up at night, try a white noise machine to drown out outside noise.
Limit Light Exposure Before Bedtime
Humans are sensitive to light. When we’re exposed to excess blue light at night, it can throw off our natural sleep/wake cycle, resulting in difficulties falling asleep. Electronics are particularly high in blue light, so try not to watch TV or use your computer or smartphone for an hour or more before bed.

Multiple Sclerosis and sleep can be a challenging combination, but learning how to sleep well when you have MS is incredibly important for your happiness, health, and overall quality of life.

When you find yourself excessively sleepy during the day or struggling to get a good night’s sleep, talk to your doctor. Whether your fatigue is due to sleep troubles or something else, they can help you come up with a plan.


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This Article is Provided by:  #MSViewsandNews

Sleep and Mental Health: Why Our Brains Need Sleep

Understanding how sleep impacts the mind and the link between sleep disorders and mental illness.


Sleep for the brain is like gas for a car. When the tank is full we get where we need to be. But as time goes on, the gauge falls lower and lower until the gas is gone and the car stops. Without the fuel it needs, the car is useless.

Our brains operate in a similar way. The only difference is the brain’s fuel is sleep. Without proper sleep, our minds begin to slow, unable to operate at their full potential. This happens until the mind becomes so deprived of the rest it needs, it breaks down. And without the commander-in-chief acting accordingly, the rest of the body pays the price.

In this guide, we are going to deep dive into the complex relationship between sleep and mental health, including how these two aspects of health are inversely related, the consequences of sleep deprivation on the mind, and the link between sleep disorders and mental health disorders.

You ready? We’re really about to exercise your mind.

Click here to continue reading

This Article is Provided by:  #MSViewsandNews

Sunday, September 8, 2019

Central Michigan Hospital plots leadership path in MS research (Blood testing for MS, NeuroFilaments and more)

  • Memorial Healthcare's neurology department is growing and engaged in cutting-edge research

  • New blood tests for MS patients are being tested that will help doctors pinpoint stage of disease and best drug to slow debilitating effects

  • Multi-disciplinary team approach cuts testing and diagnosis process to one day
Rany Aburashed, D.O.
Neurologist Rany Aburashed, D.O., is leading Memorial Healthcare's clinical renaissance and putting it on the map nationally by pioneering clinic-based research on a new blood test for multiple sclerosis on thousands of patients.
Memorial Healthcare, a small 161-bed rural referral center in central Michigan, is believed to be the only hospital in the U.S. where the Simoa Analyzer MS blood test technology is being tested, Aburashed said. There are about 100 universities that are testing the MS blood test technology on animals, experts said.
Aburashed also has helped to create Memorial's Institute Institute for Neurosciences and Multiple Sclerosis that offers patients a multi-disciplinary approach to MS care that is in effect, "one-stop shopping" for co-located neurology, orthopedics, rehabilitation and wellness programs.
"The Europeans tend to be ahead of us in terms of research into MS. They are much more aggressive after the disease and treatment," Aburashed said. "When we saw more and more evidence from the European data on neurofilaments that was not only predictive of MS but also was predictive of (how effective is the) drug working. I realized this was going to the future of MS care over the next five years and we had to have it."
While the MS blood test using "neurofilament light chain" technology, or NfL, is still under clinical trials in the U.S. and not approved by the U.S. Food and Drug Administration, it is also widely being researched in Europe.
The blood test detects NfL, a structural protein that forms part of the internal skeleton of neurons. When brain neurons are damaged or dying, the protein leaks out into the fluid that covers the brain and spinal cord. From there, the brain and spinal fluid goes into the bloodstream.
By hard work and determination, Aburashed earlier this year won approval from the hospital's institutional review board to test the NfL technology in a five-year trial. He also was able to secure the machine to test NfL, the Simoa Analyzer, from Quanterix Corp, a Billerica, Mass.-based biotech company.

This Article is Provided by:  #MSViewsandNews