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October 12, 2017 News by Patricia Silva, PhD

Fat Intake Increases Risk of Children with MS Having a Relapse, Study Suggests

Diet can play an important role in whether children with relapsing multiple sclerosis have a relapse, researchers at the University of California, San Francisco argue. Their study demonstrated that a diet with a lot of fat increases the risk of a youngster having a relapse by 56 percent, with saturated fat tripling the risk. Eating a lot of vegetables, on the other hand, cuts the risk in half, the team said. Since children with MS tend to have relapses more often than adults, the researchers figured they would be a suitable group to study diet's impact on relapse. They recruited 219 children with relapsing-remitting MS or clinically isolated syndrome from 11 centers across the U.S. Clinically isolated syndrome is a condition that can evolve in MS. The research team use a questionnaire known as the Block Kids Food Screener to analyze what the youngsters ate. They tracked the children an average of almost two years, which was plenty of time for relapses to occur. And, in fact, they did occur in 42.5 percent of the group. It turned out that fat had a particularly devastating effect on the youngsters' relapse rate. For every 10 percent increase in energy intake that came from fat, there was a 56 percent increase in the children's risk of having a relapse. Saturated fats were the biggest driver of risk. When researchers look only at these fats, they discovered that the risk more than tripled. Examples of saturated fats include processed meats such as sausages, ham, and burgers, butter, hard cheeses, and whole milk. Vegetables had the opposite effect on risk, the researchers observed. Using a cup equivalent as a standardized measure, they learned that for every additional cup of vegetables the children ate, the risk of a relapse dropped in half. To exclude the possibility that other factors influenced the results, the team included information about age, sex, ethnicity, duration of disease, body mass index, treatment, and D-vitamin levels in their analyses. This did not influence the results. The team also looked at whether other food components, such as sugar, iron, fruit and fiber, would affect the risk of relapse. They did not find any links. Although the risk associations were strong, the researchers cautioned that the study's observational design meant that it was not able to prove that fat causes relapses. But there are several ways that fat could play a role in disease processes, they argued. For instance, high fat intake triggers the release of inflammation-promoting molecules. It also affectsf gut bacteria that are linked to immune processes. Vegetables lower the risk of inflammation and immune problems, the team said. In an accompanying editorial, Dr. Kathryn Fitzgerald of the Johns Hopkins School of Medicine said the study had important limitations. Researchers gathered information on the children's diet only in the week before they enrolled in the study. This might not adequately capture more long-term dietary patterns, she said. And fat is not simply fat, she pointed out, arguing that fish oil is believed to help MS patients. Although the California research offers insight, she called for long-term studies to define diet's role in MS.

October 11, 2017 News by Patricia Silva, PhD

Among MS Patients, ‘Invisible’ Disability Leads to Poor Self-perceived Health, NYU Study Finds

Pain, walking problems and fatigue are factors that most strongly lower self-perceived health in multiple sclerosis (MS), researchers at the New York University Langone Medical Center have found. This challenges current treatment approaches focus mainly on physical disability. It suggests that “invisible disability” may be more important to how patients…

October 10, 2017 News by Patricia Silva, PhD

Researchers Identify Quality Control Regulatory Cells That Prevent the Production of Autoantibodies

The discovery of an immune cell quality control mission may have put scientists a step closer to understanding how autoimmune conditions such as multiple sclerosis arise. University of Alabama at Birmingham researchers identified regulatory immune cells with the quality control mission of destroying antibody-producing B-cells that mistakenly target the body's own tissue after an infection. An autoimmune disease is one in which the immune system attacks healthy tissue or organs instead of invaders. Eventually, the insight could lead researchers to new approaches for treating MS and other conditions caused by aberrant immune reactions. The Alabama researchers were studying the processes involved in the body's defense against a real threat — the influenza virus — when they discovered a population of immune cells whose action is relevant to autoimmune diseases. The study noted that T follicular regulatory cells appeared in the late stages of influenza infection. Their objective was to prevent the immune system from generating self-reactive antibodies — that is, those that attack the body's own tissue. These cells are poorly understood, the researchers explained. Their experiments, published in the journal Nature Immunology, focused on the molecular events surrounding the cells’ actions.  The team discovered that about a week after the infection, levels of an immune regulator called the IL-2 protein increased. This triggered the multiplication of common regulatory T-cells, or Tregs. When this phase of the immune reaction was fading, TFR cells started multiplying, reaching peak numbers about a month after infection. The formation of the TFR cells was therefore tightly linked to the processes controlling Treg production, researchers said, with falling levels of IL-2 allowing the new phase of the immune response. The TFR cells migrated to the lymph nodes — the headquarters of antibody-producing B-cells. Here, B-cells proliferate and change their antibody-producing genes to create new, stronger antibodies. But sometimes the gene changes, or mutations, give rise to an antibody that attacks the body, instead of invaders. Researchers discovered that TFR cells prevented B-cells, which gave rise to autoantibodies, from accumulating in the lymph nodes. Importantly, the TFR cells had no impact on the immune processes targeting the influenza virus. When researchers prevented TFR cells from forming or removed them from mice, the animals started producing autoantibodies, they explained. While this suggested that people with autoimmune diseases may have flawed TFR processes, the study did not investigate this, making the topic a possibility for future studies.

October 10, 2017 News by Alice Melão, MSc

Nimbus, Celgene to Jointly Research Targeting of Proteins to Treat MS, Other Disorders

Nimbus Therapeutics and Celgene have agreed to work together to identify potential therapeutic compounds that can specifically target Tyk2 and STING — two proteins involved in inflammation and innate immune response. This strategic collaboration can open new therapeutic avenues for the treatment of multiple sclerosis (MS) and several autoimmune disorders. Nimbus, headquartered in Cambridge, Massachusetts, applies chemical computational analysis to identify and develop new compounds with potential for therapeutic use in a range of diseases. Two Nimbus immunology programs are already covered under the newly established agreement: one developing inhibitors of Tyk2 and antagonists of STING protein. Tyk2, or tyrosine kinase 2, mediates the signaling of several pro-inflammatory proteins, including interleukin (IL)-23, IL-12 and type-I interferons. Inhibiting this enzyme can stop signals from passing through. This can potentially impair inflammatory response. STING, or stimulator of interferon genes, is an important activator of immune responses. As such, finding ways to block its activity can help prevent autoimmunity and reestablish immune response balance. Under their accord, Nimbus will control the program's research and development; Celgene will have the option to acquire each program covered by the alliance.

October 6, 2017 News by Ashraf Malhas, PhD

Evidence of Lymph Vessels in Human Brain May Offer New Insights into MS, Other Disorders

Groundbreaking evidence of the existence of lymphatic vessels in the human brain could answer the question of how the brain gets rid of waste products, and holds clear implications for neuroinflammatory disorders such as multiple sclerosis. The lymphatic system is a network that helps the body to rid itself of toxins and waste products. Lymphatic vessels, which are similar to blood vessels, transport a clear fluid – lymph – which is filtered in lymph nodes. It has long been thought that the brain lacks lymphatic vessels. However, a team of researchers at the National Institutes of Health (NIH), building on previous research in rodent brains, recently found evidence that the brain may actually drain waste through lymphatic vessels. The researchers injected healthy volunteers with a magnetic dye called gadobutrol, which is usually used as a contrast agent to image blood vessels. They then scanned the brains of these individuals using magnetic resonance imaging (MRI) under specific settings. This allowed them to view the dye within the outer layer of the brain, known as the dura. The MRI revealed that the dye was visible both as dots and straight lines, which might indicate lymph vessels. This suggested that the dye leaked out of blood vessels into the dura and were later 'picked up' by lymphatic vessels. These vessels were not seen when the volunteers were injected with another dye that does not leak out of blood vessels. Evidence of lymphatic vessels in the brain was also found in autopsied human brain tissue. Although a pair of 2015 studies had shown evidence of lymphatic vessels in the brains of mice, this is the first study that demonstrates that a similar system exists in human brains. “For years we knew how fluid entered the brain. Now we may finally see that, like other organs in the body, brain fluid can drain out through the lymphatic system,” Reich said . In addition to changing the way we think about the lymphatic system and the brain, this study lays the foundations for future research to investigate whether the function of the lymphatic system is altered in the brains of patients with multiple sclerosis or other disorders affecting the nervous system.

October 6, 2017 News by Patricia Silva, PhD

Lemtrada Prevented Progression of Multiple Sclerosis for Five Years, Study Shows

Two short courses of Lemtrada prevented multiple sclerosis from becoming active and progressing for five years, a study reported. Lemtrada's maker, Sanofi-Genzyme, said the study covered the two-year CARE-MS II Phase 3 clinical trial (NCT00548405) and a long-term extension (NCT00930553) trial of people with relapsing-remitting MS. In addition to demonstrating Lemtrada's effectiveness, the study showed that it was safe, researchers said. The Phase 3 trial participants had had an active disease, with at least two relapses in the two years before the study and an inadequate response to earlier treatment. The trial compared Lemtrada's effectiveness with that of Rebif. The Lemtrada group received 12-mg doses for five consecutive days at the start of the study and three consecutive days a year later. Ninety-three percent of the 435 patients who completed the trial enrolled in the extension, which followed patients for another three years. Remarkably, 60 percent of patients required no additional treatment after the two years of the Phase 3 study. Among the 376 patients who required more treatment, 30 percent had one additional Lemtrada course, 10.4 percent had two, and 1.6 percent had three. A small proportion of patients also received other disease-modifying treatments. The most common reason for additional treatment was relapse. Nevertheless, Lemtrada reduced annualized relapse rates to only 0.18 of patients by the fifth year. In addition, during the five years, 75 percent of patients experienced no worsening of their disability over six-month cycles. And 49 percent of patients' disability improved. Researchers also tracked patients' scores on the NEDA — or No Evidence of Disease Activity — index. The composite measure takes into account relapses, disease activity detected in MRI scans, and disability progression. In year five, 58 percent of patients achieved NEDA, slightly more than the 53 percent in year three. Another important finding was that patients' loss of brain tissue slowed in the first two years, and dropped further during the extension. Researchers also noted that adverse events dropped during the extension trial. Ninety-six percent were mild or moderate, and no patient left the study because of side effects. The rate of infusion-associated reactions was lower in the extension study than in the Phase 3 study. Patients who did have a reaction most often experienced headache, fever, or rash. Infections did not become more common with accumulating Lemtrada doses and, again, were less common in the extension trial. Patients most often developed colds or urinary tract infections. Autoimmune reactions against the thyroid gland were relatively common, however. Thirty-eight percent of patients developed them over the five years. Most were moderate in severity. Four patients developed various types of cancers. Researchers also examined Lemtrada in the CARE-MS I clinical trial and its extension trial. They reported long-term outcomes and safety findings similar to those in the latest study. Overall, the newest results demonstrated that Lemtrada slowed disease progression over five years in relapsing-remitting MS patients who failed to respond to previous therapy.

October 5, 2017 News by Patricia Silva, PhD

Can iPhone App Grasp the MS Experience? Duke Study Wants to Find Out

Researchers at Duke University want to determine if data collected through an iPhone app can ably capture individual experiences in people with multiple sclerosis to improve doctor-patient communication and overall disease understanding. According to a National MS Society report, the researchers want to investigate the benefits combining mobile phone-based data with machine learning (the ability of a smartphone to mimic human behavior) and patient participation. The study is currently enrolling MS patients, 18 or older, live in the United States and be able to read and understand English. Participants must own or have daily access to an iPhone (iOS 9 or greater) to download a free, MS Mosaic app from the Apple Store. The app is not yet available for Android phones. The rationale behind the study is that MS can be an extremely complex condition, with symptoms ranging from numbness, walking difficulty, to vision impairment and fatigue. Each patient's experience is different and can be affected by medication, emotional health, and environmental factors. This complexity can complicate research. Study participants will receive daily, weekly and monthly questionnaires to fill about their symptoms. Daily surveys should take no longer than a minute to complete, and weekly surveys about ten minutes. Initial registration should take about 20 minutes, the NMSS report says. In some of the surveys, participants will be asked to perform specific tasks while holding or using the mobile phone, like walking 25 steps, turning around, then walking back 25 steps – while holding the phone. Other tests include tapping on the phone screen repeatedly to test motor speed, coordination and fatigue, or playing a pattern game to assess short-term memory. These tasks should take about five minutes each. Patients can choose not to answer some of the questions or to participate in certain tasks. All information is collected through the app, and will be sent to a secure data server. Participants can export data to share with a healthcare provider. Each person will be identified by a code, and data will be analyzed in a way that maintains confidentiality. Researchers, however, be able to identify a participant should they need to do so for "research integrity or legal purposes," the report states. Questions regarding this study can be answered by sending an email to [email protected].

October 3, 2017 News by Jose Marques Lopes, PhD

Non-invasive Brain Stimulation Reduces MS Fatigue, NYU Study Shows

Non-invasive brain stimulation reduces fatigue in multiple sclerosis patients, concludes a study by researchers at New York University. Fatigue is one the most disabling symptoms of MS, affecting roughly 75 percent of people with the disease. Doctors often prescribe drugs to treat narcolepsy, as well as behavior-based treatments and exercise programs, but their benefits have not been consistent. This led scientists to study a technique of brain stimulation called transcranial direct current stimulation (tDCS), which had shown positive results in earlier neurology studies, including improvements of cognitive symptoms in MS. In tDCS, doctors place electrodes on the scalp via a headset to apply a low-amplitude electrical current at the dorsolateral prefrontal cortex — a brain region believed to play a role in fatigue and cognitive symptoms. The technique has been proven safe and tolerable. The NYU study randomly assigned 27 MS patients to receive either tDCS or placebo. Patients got treatment while playing a cognitive game directed at the brain’s processing speed and working memory. Sessions lasted 20 minutes each and took place five days a week, at patients’ homes. Participants reported their level of fatigue after 20 sessions, using a scale known as the Patient-Reported Outcomes Measurement Information System (PROMIS) that grades fatigue on a score of up to 32. A higher score correlates with more fatigue. The results showed a significant 5.6-point drop with tDCS, compared to a 0.9 point increase in the placebo group. Furthermore, patients may benefit from more sessions, since those who underwent 20 sessions reduced fatigue more than those who did only 10. The study also showed that patients with the most fatigue at baseline saw the biggest improvements. Remarkably, many participants reduced their fatigue to near-normal levels, researchers observed. Further studies are needed to ascertain the precise mechanism behind tDCS. Scientists believe it changes the brain’s excitability, which improves connections and facilitates learning. Meanwhile, the study's authors strongly advise MS patients not to try over-the-counter stimulation technologies outside of a reliable research setting. The research team plans to test tDCS in larger clinical trials for MS-related fatigue, motor and cognitive symptoms. Currently, the Multiple Sclerosis Comprehensive Care Center at NYU Langone Health is the only one in the United States to offer tDCS to MS patients.

October 3, 2017 News by Alice Melão, MSc

MS Society, TG Therapeutics Partner to Advance Potential Oral Therapy for Progressive MS

Fast Forward, a non-profit subsidiary of the National Multiple Sclerosis Society, will give financial support to TG Therapeutics to advance TGR-1202 (umbralisib) into preclinical testing as a potential oral therapy for progressive forms of multiple sclerosis. The support, whose value was not specified, is part of a Sponsored Research Agreement between Fast Forward and the company. Research work will be led by Lawrence Steinman, MD, a professor of pediatrics, neurology, and neurological sciences at Stanford University. TGR-1202 is an orally administrated inhibitor that blocks a signaling enzyme called PI3K delta. Immune cells such as B-cells have high levels of this enzyme, which is thought to be important for cell proliferation and survival. "We look forward to evaluating umbralisib [TGR-1202]'s effect on our preclinical progressive MS models in hopes to move umbralisib closer to clinical development in MS," Steinman said. The approval of Ocrevus (ocrelizumab), by Genentech, to treat primary progressive and relapsing multiple sclerosis underscored the potential of B-cell-targeted therapies for MS patients. As a result, investigative drugs that also aim to bolster B-cell survival or activity, such as those being developed by TG Therapeutics, are an attractive approach to potentially treating patients. Another potential treatment by the company — an engineered antibody, TG-1101 — targets a specific sequence on the CD20 protein found on immune B-cells. This infusion therapy is now in two Phase 3 clinical studies for relapsing multiple sclerosis, ULTIMATE I and ULTIMATE II. Both are currently enrolling patients at sites in Kentucky, Tennessee, and New York.

October 2, 2017 News by Patricia Silva, PhD

Long-term Lemtrada Treatment Benefits Demonstrated in Extension Study

A five-year study demonstrated that Sanofi-Genzyme’s Lemtrada (alemtuzumab) provides long-term benefits for relapsing-remitting multiple sclerosis patients, reducing relapse rates and preventing the progression of the disease. Importantly, most patients required only the standard two-phase treatment course. Few needed additional courses because of relapse or new brain lesions. The study,…

September 29, 2017 News by Patricia Silva, PhD

Switzerland First in Europe to Approve Ocrevus for Relapsing and Primary Progressive MS

Swiss regulatory authorities approved Ocrevus as a treatment for primary progressive and relapsing forms of multiple sclerosis on Sept. 28, making it the first approval of the drug in a European country. Since Switzerland is not part of the European Union, the approval will not affect the drug's regulatory status in other European countries. So far, the Roche/Genentech drug Ocrevus has been approved in North America, South America, the Middle East, Ukraine, and Australia. Like other countries where Ocrevus has been approved, it's the first drug OK'd in Switzerland for primary progressive MS, a form of the disease where disability moves forward relentlessly. And, as in other countries, the treatment option is equally appreciated among patients with relapsing types of MS. Ocrevus — an antibody that targets B-cells with the surface factor CD20 — was studied in two large Phase 3 trials in patients with relapsing MS called OPERA I and OPERA II (NCT01247324 and NCT01412333). Another trial, called ORATORIO (NCT01194570), is focused on people with primary progressive disease. The trials showed that the treatment significantly reduced disease activity and prevented progression in both patient groups. Researchers compared Ocrevus to Rebif (high-dose interferon beta-1a) in relapsing MS and to a placebo in primary progressive MS. Scientists also consider the drug to have a good safety profile. The most common side effects during the trials were mild-to-moderate infusion reactions and upper respiratory tract infections. Since its approval, researchers also have concluded that the treatment is less expensive than interferon. Ocrevus was approved in the U.S. on March 28, 2017. In the months that followed, many patients were concerned about the trial findings of more cancer cases in the treated, compared to control, groups. Since then, an increased risk of cancer with Ocrevus has not been confirmed, and researchers underscore that it is instead the coincidental and unusual circumstance that there were no cancer cases in the control group that created the imbalance. The European Medicines Agency is still processing the marketing application for Ocrevus. Roche reports that the company has filed marketing applications in more than 50 countries worldwide.

September 29, 2017 News by Stacy Grieve, PhD

Falls Common Among Wheelchair, Scooter Users in People with MS, Study Reports

The majority of people living with multiple sclerosis who use wheelchairs or scooters for mobility reported falling at least once over a six-month period, according to a new study. While most studies have focused on ambulatory MS patients, this may be the first study to assess the prevalence and circumstances of falls among those who already experience significant mobility issues and require the use of wheelchairs or scooters to get around. In ambulatory MS patients who are able to move around on their own, about 50 percent reported falling during a six-month period. The current study recruited 44 MS patients from May 2014 to July 2015 who required wheelchairs or scooters to move about. These patients were from medical centers across the United States and Asia. They were asked to complete a survey focusing on the prevalence of falls, the frequency of injuries, the circumstances surrounding the falls, and quality-of-life indicators. Thirty-three of the 44 participants (75 percent) reported falling at least once in the previous six months. This number is higher than any of the other studies that assessed the prevalence of falls in MS patients. Many of these people experienced more than one fall within those six months. Of these falls, 87.5 percent occurred inside the home. The top four activities reported by participants that led to these falls included using the toilet, transferring, walking short distances, and reaching for an object. Some of the people said the falls were serious, and 8 percent of participants reported an injury because of their fall. Perhaps for this reason, many reported concerns about falling (76.7 percent). And, more telling, 65.9 percent of these MS patients reported altering their activities because they feared falling. The use of mobility devices may affect the prevalence of falls. Participants were asked if they had fallen using a specific mobility device. Here is how they responded: 66.7% reported falling while using power wheelchairs; 37.5% fell while using manual wheelchairs; 66.7% fell when using scooters; 71.4% reported falling while using a walker; 100% fell while using a cane. Because of the high prevalence of falls while using a mobility device, researchers said, clinicians should provide better education regarding the use and function of these mobility devices. There were no significant correlations between people who experienced falls and quality-of-life indicators in this study. Results from the study highlight the need for interventions specifically targeted for MS patients who use mobility devices such as wheelchairs and scooters. The body of research regarding predictors of falls suggest that some of the risk factors can be modified; therefore, more effort should be made to prevent falls using targeted rehabilitation interventions.

September 27, 2017 News by Patricia Silva, PhD

Woman with MS and Spouse to Trek 500 Miles to Raise Awareness, Funds for MS Society

April and Bernie Hester are busy planning their second 500-mile thru-hike of South Carolina's Palmetto Trail, which they will begin on Oct. 1 to raise awareness for multiple sclerosis and funds for the National MS Society. Thousands of people hike parts of the trail every year, but few do the entire 500-mile hike, said Suzette Anderson, of the Palmetto Conservation Foundation (PCF), an organization dedicated to conserving South Carolina's natural and cultural resources. The couple's "Finish MS Hike" is the second time they'll be hiking the full trail this year. In April they started hiking from the sea and 66 days later completed the trail in the mountains. This time they'll start in the mountains and end at the sea. The couple will traverse over mountains, on trails, through cities, and on roadways. April, who has MS, is hoping that her efforts will bring much-needed awareness to the condition and that the pair can reach their goal of raising $100,000 for MS research toward a cure. Their effort, combined with the debilitating effects of MS, are among the reasons why April and Bernie Hester were recognized as trail ambassadors by the PCF. The couple will post regular updates on their “Finish MS Hike” blog and Instagram account, to allow people to follow their adventures, read about their journey, and gain insight as they face and conquer challenges along the way. The couple has already written a few entries to keep their audience informed. The Palmetto is the longest trail and largest trail construction project in South Carolina. Today, the trail crosses the state from Walhalla in the mountains of Oconee County to Awendaw on the coast in Charleston County. Another 150 miles in the Midlands and Upstate remain to be acquired and constructed. To help raise money to "Finish the Trail," the PCF and RJ Rockers Brewing Company have combined their passions for trekking and craft beer to create Palmetto Trail Pale Ale. A portion of sales goes to support and finish the Palmetto Trail. You can buy Palmetto Trail Pale Ale at any of the following locations: RJ Rockers Brewery, Craft and Draft, Texas Roadhouse, Thirsty Fellow, Flying Saucer, Capital City Club, Triangle Char+Bar, Bohemian Bull, Publico Kitchen & Tap.

September 27, 2017 News by admin

RebiSmart Usage Among Young, Less Disabled MS Patients May Improve with More Knowledge, Study Suggests

Relapsing-remitting multiple sclerosis (RRMS) patients accurately report the use of the RebiSmart autoinjector to their neurologists, a questionnaire-based study has found. The Phase 4 noninterventional CORE study also suggests that being knowledgeable about RebiSmart is a key factor in improving usage in younger patients and those with lower disability levels.

September 25, 2017 News by Patricia Silva, PhD

Goal Attainment Interventions May Reduce Cognitive Fatigue in MS, Study Finds

Behavioral therapy focusing on goal attainment might reduce cognitive fatigue in multiple sclerosis patients, finds a study that used brain imaging to examine goal-oriented tasks involving rewards. Since fatigue is one of the most common MS symptoms, affecting up to 90 percent of patients, researchers at the Kessler Foundation in East Hanover, New Jersey, say their findings could open the door to new non-medication approaches to treating MS-related fatigue. Scientists believe that a part of the brain, called the fronto-striatal network, causes fatigue. But studies also show that the network is active during goal attainment tasks, and that such tasks can reduce fatigue in healthy people. Equipped with this knowledge, Kessler researchers recruited 19 MS patients and 14 healthy controls, and exposed them to one of two conditions. In the first, they had the chance to win money while gambling. Researchers called this the outcome condition. The second condition did not include the prospect of a reward, or outcome. The tasks were performed in a brain scanner. Using functional magnetic resonance imaging of the brain — a method that tracks brain activity by monitoring blood flow — researchers could study how different tasks activated the fronto-striatal network. It turned out that the prospect of a reward activated parts of the network in deep brain structures, while parts of the prefrontal cortex were more active during the task without a potential reward. Importantly, the activation seen during the reward condition was linked to significantly lower levels of fatigue, which researchers measured outside the scanner. While researchers used a gambling task to study the process, similar exercises like achieving a good score on a test, might work equally well, researchers said. In fact, goal attainment is already incorporated in many neuropsychological rehabilitation efforts, including in MS.

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