August 9, 2019 News by Marisa Wexler, MS Music While Walking Makes MS Patients More Motivated and Less Mentally Drained, Study Suggests People listening to music during an extended walk tend to sync their steps to its beat ā and forĀ those with multiple sclerosis (MS), such synchronization helps to overcome mental fatigue and improve motivation, a study found. “Continuous 12 min walking to music, metronomes and in silence:…
July 23, 2019 News by Marisa Wexler, MS Antiviral and Nausea Treatments Ease Fatigue in MS, Small Study Reports An antiviral medication called amantadine and ondansetron, which treatsĀ chronic nausea, both work to reduce fatigue in people with multiple sclerosis (MS), but amantadine may be more effective, a single-site trial in Iran reports. The study, “Comparison of the effects of amantadine and ondansetron in treatment…
July 19, 2019 News by Marisa Wexler, MS Convelo Therapeutics and Genentech Join Forces to Develop Remyelination Therapies Convelo Therapeutics has announced a collaboration with Genentech, a member of the Roche Group, to work toward the development of new remyelination therapies for multiple sclerosis (MS) and other myelin disorders. āWe are excited to be working with Genentech to…
July 16, 2019 News by Marisa Wexler, MS Independent Mouse Study Reinforces Remyelinating Potential of ISP Therapy A new study demonstrates that intracellular sigma peptide (ISP) can promote remyelination in a mouse model of multiple sclerosis (MS). Importantly, this study was independent of NervGen, a pharmaceutical company that is developing an ISP-like compound āĀ NVG-291Ā ā for the treatment of nerve injury and MS. The study,…
June 25, 2019 News by Marisa Wexler, MS New Jersey Health Foundation Awards $70,000 to Kessler Foundation Researchers Studying MS and Stroke Two researchers at Kessler Foundation were awarded grants of $35,000 each by the New Jersey Health Foundation to pursue their investigations into new ways to improve rehabilitative care for disabilities caused by multiple sclerosis (MS) and stroke. One of the awardees…
June 24, 2019 News by Marisa Wexler, MS Blocking Sortilin Protein May Be Potential Treatment for Chronic Nerve Pain, Mouse Study Suggests Inhibiting the function of a protein called sortilin ā an important regulator of nerve damage-induced pain in mice ā may represent a potentially effective strategy for treating chronic pain in humans, including those with multiple sclerosis, a study in mice suggests. The researchers say more work is needed…
June 20, 2019 News by Marisa Wexler, MS Potential Mechanism Behind Effectiveness of B-cell Depletion Therapy in MS Uncovered The loss of immune B-cells, and the resulting changes in the profile of immune T-cells, is a major mechanism of action for the beneficial effects seen with ublituximab treatment in multiple sclerosis (MS) patients, a study suggests. B-cells are a type of immune cell best known for producing…
June 20, 2019 News by Marisa Wexler, MS Childhood MS Linked to Greater Cognitive Impairment in Adulthood, Study Finds People with pediatric-onset multiple sclerosis (POMS) have a greater decline in cognitive function, and are more likely to experience cognitive impairment in adulthood, than those whose disease began when they were adults, a study reports. The study, “Long-term Cognitive Outcomes in Patients With Pediatric-Onset vs Adult-Onset…
June 13, 2019 News by Marisa Wexler, MS Elevated Blood Pressure May Predict Brain Bleeding in RRMS Patients Treated with Lemtrada, Study Suggests New research suggests that rising blood pressure might be predictive of intracranial hemorrhage ā bleeding in the brain, a serious and sometimes fatal condition ā in people with multiple sclerosis (MS) who are receiving treatment with Lemtrada (alemtuzumab). The study, titled “Intracerebral haemorrhage during…
June 12, 2019 News by Marisa Wexler, MS Biotech Startup Receives Funding to Pursue Cell-based Therapies for Neurological Disorders Startup company Oscine Therapeutics has received an investment from Sana Biotechnology to support the research and development of cell-based therapies for a variety of neurological disorders, including multiple sclerosis (MS). This venture is based on work done over the past several decades in the lab of Steve…
June 11, 2019 News by Marisa Wexler, MS Study Identifies Possible Genetic Causes of MS Scientists are zeroing in on mutations in a few genes that appear to be major risk factors for developing multiple sclerosis (MS). The results of their research suggest there are common biological pathways that cause the disease. The study, “Exome sequencing in multiple sclerosis families identifies 12…
June 6, 2019 News by Marisa Wexler, MS Roche, Sutter Health Testing Floodlight Mobile App That Monitors Patients’ MS Sutter Health, a California-based healthcare group, has partnered with the biotechnology company Roche to test a new mobile app that aims to improve monitoring of symptoms in people who have multiple sclerosis (MS). The app, called Floodlight, “may give neurologists access to meaningful, actionable patient data to…
May 29, 2019 News by Marisa Wexler, MS Celgene and MS Association of America Collaborating to Boost Knowledge on Brain Health in MS Biopharmaceutical company Celgene has teamed up with the Multiple Sclerosis Association of America (MSAA) to launch a new initiative called MS MindShift: A New View of MS, aimed at educating the multiple sclerosis (MS) community on brain health. Although it’s an “important topic,” brain health “is not…
May 20, 2019 News by Marisa Wexler, MS #AANAM ā Evobrutinib Continues to Show Potential for MS, 48-week Phase 2 Data Suggest Investigational therapy evobrutinib, also known as M2951, can reduce relapse rates and brain lesions in people with relapsing forms of multiple sclerosis (MS), 48-weekĀ data from a Phase 2 clinical trial suggest. Updated results from the trial (NCT02975349) were presented at the recent 2019 annual…
May 16, 2019 News by Marisa Wexler, MS #AANAM ā Gut Bacteria May Play Role in Pediatric MS, Studies Suggest As strange as it is to think about, many bacteria live in the human body, most of which are found in the gut (often referred to as the gut microbiome). These bodily roommates affect health in many ways that are only beginning to be understood.Ā …
May 15, 2019 News by Marisa Wexler, MS #AANAM – Biogen Offers Update on Development Plans for MS Therapies At the 2019 annual meeting of the American Academy of Neurology (AAN),Ā Multiple Sclerosis News TodayĀ sat down with Bernd Kieseier, MD, global head of multiple sclerosis at Biogen, to discuss the company’s portfolio, latest data, and therapeutic development plans in the field of multiple sclerosis (MS). Kieseier said…
May 13, 2019 News by Marisa Wexler, MS #AANAM – Ocrevus Effective in RRMS Patients with Poor Responses to Other DMTs, Early Trial Data Suggest Early, one-year data from theĀ Phase 3 CHORDS study show that OcrevusĀ effectively prevents relapses and disease progression inĀ relapsing-remitting multiple sclerosis (RRMS) patients who have had poor responses to other disease-modifying therapies. These interim results were presented at the 2019 annual meeting of the American Academy of NeurologyĀ (AAN) in…
May 10, 2019 News by Marisa Wexler, MS #AANAM – Interferon Beta Exposure Does Not Seem to Increase Risk of Pregnancy Complications, Study Suggests Exposure to interferon beta does not seem to increase the risk of complications during pregnancy in women with multiple sclerosis (MS), new research suggests. The data were presented in an oral presentation, “Pregnancy and Infant Outcomes with Interferon Beta: Data from the European Interferon Beta Pregnancy Registry and MS…
May 8, 2019 News by Marisa Wexler, MS #AANAM – Research Suggests Extended Interval Dosing of Tysabri Can Decrease Risk of PML New data suggests that treatment withĀ TysabriĀ (natalizumab) in an extended interval dosing regimen is associated with a significantly lower risk ofĀ progressive multifocal leukoencephalopathyĀ (PML) in patients with multiple sclerosis (MS), compared with the standard interval dosing. The data was presented byĀ Lana Zhovtis Ryerson, MD, on May 7 at the 2019Ā …
May 8, 2019 News by Marisa Wexler, MS #AANAM – Research Suggests Misconceptions About MS Risk in Pregnant Women New research suggests that even though pregnant women with multiple sclerosis (MS) are often viewed as high risk by their physicians, pregnancy Ā does not seem to increase the likelihood of adverse obstetrical outcomes for those patients or their babies. The research was presented at the 2019 Annual Meeting…
May 6, 2019 News by Marisa Wexler, MS #AANAM – IV Therapy May Be More Effective Than Oral Treatment in Younger RRMS Patients, Research Suggests Infusible disease-modifying treatment ā that is, therapies given intravenously ā might have greater benefits for younger people with multiple sclerosis (MS) than oral ones, new research suggests. The research was presented at the ongoing American Academy of Neurology (AAN)’s annual meeting (May 4-10) by Brandi Vollmer,…
May 6, 2019 News by Marisa Wexler, MS #AANAM ā DMTs Primarily Responsible for Rising Healthcare Costs for MS Patients, Study Suggests A trend of rapidly increasing costs for disease-modifying therapies (DMTs) used to treat multiple sclerosis (MS) appear to be the primary driver behind the overall rise in healthcare costs for people with MS, a study suggests. These data were presentedĀ in a…
May 3, 2019 News by Marisa Wexler, MS #AANAM – Precision Innovative Network and Splice Machine Will Present Predictive Healthcare Application at AAN Meeting A new clinical application prototype that uses machine learning to help physicians predict the best treatment options for patients with multiple sclerosis (MS) will be unveiled at theĀ American Academy of Neurology’s 2019 annual meetingĀ May 4ā10, in Philadelphia, Pennsylvania. The prototype is called PIN Population Data Platform. It has been…
April 26, 2019 News by Marisa Wexler, MS Cellular Senescence Implicated in MS Development, Study Suggests Cellular senescence ā the process of aging at the cellular level ā may play a role in the development of primary progressive multiple sclerosis (PPMS) by limiting the ability of myelin-producing cells (oligodendrocytes) to renew and mature. The study with that finding, “Cellular senescence in progenitor…
April 15, 2019 News by Marisa Wexler, MS Web Portal That Detects Cognitive Changes via Language Tests Detailed in Study A new web portal called Talk2Me that detects early changes in language could help doctors diagnose or determine progression in neurodegenerative disorders likeĀ multiple sclerosis (MS), the scientists who created it suggest. The open platform portal, whichĀ gathers language data through an array of cognitive tasks performed…
April 12, 2019 News by Marisa Wexler, MS Excess Body Fat Spurs Disease Progression by Impact on Immune Cells, Study Suggests A link between fat molecules calledĀ ceramides andĀ worsening disease in overweight and obese people with multiple sclerosis appears to exist, a study reports, with its findings suggesting that ceramides prompt the growth of immune cells calledĀ monocytes, which in turn spurs disease progression. These results also strengthen the likelihood thatĀ lifestyle factors, like diet and weight, can act as disease modifiers, its researchers said. High body mass index has been linked to the risk of developing MS, but for reasons that aren't clear. One idea is that weight-induced differences in lipids (fat molecules) in the blood, because they are involved in several cellular signaling processes, may affect MS and its course in people with higher BMIs. To test this hypothesis, a team led by researchers atĀ the Advanced Science Research Center (ASRC) at The Graduate Center and at the Icahn School of Medicine at Mount Sinai analyzed 54 patients with relapsing-remitting MS (MS), ages 18 to 60, and with normal or high BMIs (27 people in each group). Participants were followed for two years. BMI is a measure of body fat based on height and weight. A normal BMI is defined as one between 18.5 and 24.9, while a person is considered overweight with a BMI of 25ā29.9, and obese it is 30 or higher. Researchers took blood samples, and looked for differences between the groups in terms of both immune cells and blood lipid profiles. They then validated their findings in a separate group of 91 RRMS patients. Patients with high BMIs tended to have more monocytes than those with normal BMIs. Monocytes can travel through the blood to tissues where they develop into macrophages, immune cells with various functions that are best known for "eating" invading bacteria. Monocytes can also travel to the brain and damage nerve fibers. Overweight and obese patients also had significantly higher levels of ceramides compared with normal-weight patients, and the researchers wondered if a link might exist between the two. Through a set of experiments in cells, they discovered that ceramides cause epigenetic changes in monocytes; that is, they alter the way their genomes are "read," so they alter gene activity. Specifically, ceramide-treated cells showed a type of epigenetic change called methylation ā which generally turns genes "off" ā in genes that normally help prevent cells from dividing. Conceptually, these genetic changes serve to unleash monocytes, leading them to grow more (proliferate) than they otherwise might. The researchers also found more methylation on the genomes of monocytes from high-BMI patients than those from low-BMI patients, and they noted that the overweight or obese patients also tended to have greater disease activity, worse disability progression, and more brain lesions on MRI (magnetic resonance imaging) scans on follow-up. Finally, the researchers tested a mouse model of MS, giving one group of mice a standard diet and another a high-fat diet. Mice fed the high-fat diet were found to have greater disease severity, more brain lesions, and more monocytes, confirming the findings seen in MS patients. "This study gives us a much-needed view into the environmental influences that can affect and change the behavior of cells in an individual's body," Kamilah Castro, the study's first author, said in a press release. "Our findings suggest that increased levels of saturated fat as a result of dietary habits are one likely cause of the epigenetic changes that advance MS, which gives us a starting point for a potential intervention." According to the team, the findingsĀ support the concept of nutri-epigenomics:Ā that is, the ability of food to alter the way the genetic information is interpreted by each cell, and suggest that "weight management and dietary intervention" might affect MS prognosis. One limitation was the study's small size, its researchers noted. "While we consider our results ā¦ very exciting and mechanistic, we acknowledge that the potential consideration of ceramide levels as biomarkers for disease progression in MS would require validation ... using larger cohorts with a longitudinal and/or cross-sectional design," they concluded. "It will also be important to evaluate the effectiveness of dietary intervention (with an emphasis on the reduction of specific classes of saturated fats), as potential modulator of plasma ceramide levels and possibly of disease course in MS patients."
April 4, 2019 News by Marisa Wexler, MS CMSC Announces Technology Contests to Improve MS Patients’ Quality Of Life TheĀ Consortium of Multiple Sclerosis Centers (CMSC) announced two contests that will be featured at itsĀ Annual Meeting, May 28āJune 1 in Seattle, Washington. The contests, calledĀ āDesign for Rehabilitation ā Take the Challenge” and “CMSC Neuroinnovator,ā are aimed at creating new technologies to improve the quality of…
April 3, 2019 News by Marisa Wexler, MS Cleveland Clinic Neurologist Applauds Mayzent’s FDA Approval, But Surprised by Those It May Not Treat When theĀ U.S. Food and Drug Administration approvedĀ the disease-modifying therapy Mayzent forĀ relapsing types of multiple sclerosis, itĀ specified in its label that the treatment was for people withĀ clinically isolated syndrome, relapsing-remitting MS, and ā importantly āĀ secondary progressive MSĀ provided they have "active" disease. The approval is good news, an MS researcher and physician saidĀ toĀ Multiple Sclerosis News TodayĀ in an interview, but "surprising" in that the FDA's decision was largely based on a trial that didn't involve CIS patients and wasn't focused on responses among particular types of SPMS. āIt's the first time that I've seen in the MSĀ field that regulatorsĀ made an approval designation ā activeĀ secondary progressive MS ā based on an underpowered subgroupĀ analysis,ā saidĀ Robert Fox, MD, a neurologist at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. Novartis'Ā medication, as a first oral therapy approved in the U.S. forĀ a form ofĀ SPMS,Ā is a big step forward in MS treatment, he said. But details of the FDA's decisionĀ caughtĀ him off guard. Fox served on the steering committee for the EXPAND Phase 3 clinical trial ,Ā on which the FDA decision was largely based.Ā His clinic was also one of the sites treating and evaluating patients in this pivotal study. Results of the EXPAND trial showed thatĀ Mayzent could reduce the risk of disability progression at three months (the trialās primary endpoint, or goal) by 21% in treatedĀ SPMS patients, compared to those given aĀ placebo. Among those with active SPMS (meaning with relapses), a 33% reduction was observed. The treatment, an S1P modulator that works in part to keep lymphocytes from entering the brain to trigger inflammation,Ā alsoĀ decreased the annualized relapse rate by 55% and improved cognitive processing speed in all treated patients.Ā āWhat was found, and I think quite clearly found in a large-size study, was that siponimod in patients with secondary progressive MS clearly slowed the progression of clinical disability over the course of the trial,ā Fox said. āIt's a statistical concept ā obviously patients either progress or they don't progress ā but on an overall basis there was a 21% slowing in the rate of progression of clinical disability.ā The FDAās decision is particularly important for SPMS patients. While Ocrevus (ocrelizumab) alsoĀ treats all relapsing MS forms and people with primary progressive disease (PPMS), it's an intravenous therapy given every six months. Mavenclad (cladribine), approved for relapsing patients in the U.S. just days after Mayzent, is another oral and active disease therapy. To Fox, Mayzent seemed to reach beyond only those secondary progressive patients with clinically active disease. āReally, this is the only drug that's been found to be effective in secondary progressive MS," he said. āTo that degree, it stands alone.ā That's why two points in the FDA's decisionĀ surprised him. The firstĀ is the label's specific mention of clinically isolated syndrome. CISĀ is defined asĀ theĀ first clinical presentationĀ of this diseaseĀ ā aĀ neurological episode that lasts at least 24 hours, and is characterized by inflammatory demyelination (the loss of myelin, the protective coat surrounding neurons). Ā For clinicians like Fox, CIS is a first manifestation of MS ā a kind of "mono sclerosis."Ā Since thereās only one documented attack, it canāt yet be considered multiple sclerosis, āas the multiple hasn't happened,ā Fox said, but many "in the field consider CIS to be ā¦ an early stage of MS." āIf the patient has a whole bunch of lesions on their brain [as seen on an MRI scan] and they had a single clinical event, ah, probably, they have MS,ā he said. Regulatory bodies like the FDA,Ā however,Ā have historically considered CIS to be its own separate entity. That makes this decision doubly surprising, according to Fox, since the EXPAND trial only enrolled patients with SPMS, not CIS. Ā āIt's the first time I've seen them approve for CIS specifically when there wasn't a trial in CIS,āĀ Fox said. āI agree with it ā I don't have a problem with it ā it just surprised me that the regulators were so progressive in their appreciation of MS.ā The second ā and far more unsettling ā surpriseĀ wasĀ the FDAās decision toĀ only approve Mayzent for āactiveā SPMS patients, instead of all SPMS patients. This decision didnāt come out of nowhere, he noted, but it remains puzzling in the context of the EXPAND trial.Ā InĀ compiling trial results, investigators did a subgroup analysis ā as they often do, almost as an aside for research reasons ā and found more favorableĀ responses to Mayzent treatmentĀ in patients with active inflammation beforeĀ the trial's start, those it determined to be with "active" disease. Ā āThere was a third of patients who had a relapse in the two years prior to enrollment, and those patients actually had a 30% slowing in disability progression, compared to the 21% overall,ā Fox said. This certainly does suggest that Mayzent can be more effective in people with active disease ā but there's a catch. The trial itself was not designed to make such a distinction. It enrolled SPMS patients regardless of activity, and its priority goal was changes in disease progression across all who were treated with Mayzent or given a placebo. Ā āWhat's important is that the trial was powered for the overall outcome. It was not powered for subgroup analysis,ā Fox said,Ā considering this a crucial point.Ā In clinical studies, being āpoweredā refers to theĀ enrollingĀ of whatever specific number of participants a study needs to ensureĀ itsĀ results will reach statistical significance. More people are redundant and, as such, an unnecessary cost; fewer could mean that trial's conclusions cannot be supported by rigorous scientific measures.Ā In other words, Fox said, the only conclusions that can be drawn from the EXPAND study reliably ā with rigor ā are based on data drawn from all its SPMSĀ patients, not aĀ subgroup with active disease. This trial āfollowed over 1,600 patients for the clinicalĀ disability. These are purposely powered so that you're not following twice as many people as you need toĀ ā¦ you're powered for that primary outcome,ā he said. āSo, how could they [the FDA] look at a subgroupĀ analysis and make an approval decision based on a subgroupĀ analysis that was underpowered?ā The neurologist gave as examplesĀ other subgroup differences found in trial analyses that didn't affect regulatory approval ā but to his mind, equally could have.Ā One was an analysis findingĀ female SPMS patients respondedĀ to the therapy better than males,Ā showing lesser disease progression. "So why didn't they just approve it for the females and not the males?" Fox asked. But, when asked, Fox did not think the labelĀ toĀ necessarily be an error. "My point is the absurdity of it," he said. "How could they make the regulatory approval based on a subgroupĀ analysis that wasn't powered for conclusions?" He was also particularly troubled becauseĀ the FDAĀ ādidn't define what āactiveā means āĀ is it just a relapse, or is it MRI disease activity?"Ā For many clinicians, āactiveā SPMS refers to ongoing inflammation that can be observed on MRI (magnetic resonance imaging) scans. In EXPAND, however, the active subgroup was defined as patients with clinical relapses within two years of being enrolled in the trial. Fox worries about this apparent lack of a regulatory definition of "active" SPMS, since āobviously, the insurance companies are going to seize upon that, and they're going to look for every way they can to avoid covering it for patients.ā Mayzent, Fox agreed,Ā is likely to be expensive. The therapy is reported to carry a U.S. list price ofĀ $88,500 a year. āI always have a concern about the cost of these drugs. They're all fearfully expensive,ā he said, noting he treats SPMS patients. His focus now is on working to ensure that possible regulatory and financial hurdles wonāt pose too much of an obstacle for patients, especially those with SPMS. āI don't know what the insurance companies are going to do with this, but I'm hoping that it is available for my patients, and I say that as their clinician,ā Fox concluded.
March 25, 2019 News by Marisa Wexler, MS Body Mass Index, but Not Age at Puberty, Linked to Higher MS Risk, Study Suggests Body mass index (BMI), but not the age at which people start puberty, could increase the risk of multiple sclerosis (MS), a study suggests. The study, “Effect of age at puberty on risk of multiple sclerosis: A mendelian randomization study,” was published in the journalĀ …