February 11, 2019 News by Jonathan Grinstein Social Cognition Issues Linked to Damage in Specific Brain Region in RRMS Patients, Study Shows Issues with social cognition can occur inĀ relapsing-remitting multiple sclerosis (RRMS) patients even without the presence of cognitive impairment, and are related to damage in a specific brain region known as the amygdala, a study reports. The study, āSocial cognition deficits and the role of…
February 11, 2019 News by Jonathan Grinstein Petition Urges NHS England to Make Ocrevus Available for PPMS Patients More than 21,000 people have signed a petition calling for Ocrevus (ocrelizumab) to be made available by the National Health Service (NHS) in England for people with primary progressive multiple sclerosis (PPMS). According to anĀ MS Trust press release, the…
February 8, 2019 News by Jose Marques Lopes, PhD Medicare Rules, Higher Cost-sharing Load Increase Out-of-pocket Spending for MS Therapies, Study Reports Restrictive access policies by Medicare and a rising cost-sharing burden lead to an increased price of disease-modifying therapies for multiple sclerosis patients, according to new research. The findings also revealed that Medicare beneficiaries without a low-income subsidy may spend on average $6,894 for their MS treatments in 2019, with generic versions of Copaxone representing the highest burden. Approximately 25-30% of patients with MS are covered by Medicare through disability. In 2013, MS Medicare beneficiaries with MS and without low-income subsidies averaged $4,389 a year in out-of-pocket expenses, second only to hepatitis. Despite a greater number and diversity of DMTs for MS treatment, their price has increased substantially over the past two decades. In fact, expenses related to DMTs for MS are among the highest by class in the Medicare market. āItās a dysfunctional market that lacks the typical incentives for most other consumer prices,ā Daniel Hartung, the studyās lead author, said in anĀ Oregon Health & Science University (OHSU) press release written by Erik Robinson. āAside from the public optics, there are few incentives for companies not to raise prices. Most intermediaries in the drug distribution channel, including drug companies, benefit from higher prices,ā Hartung said. These high prices may lead to reduced access, as insurance companies can restrict coverage or manage use through prior authorization or step-therapy policies, and high deductibles or cost-sharing components in health plans that increase the financial burden for patients. Now, a team at OHSU and theĀ Oregon State University College of Pharmacy used prescription drug plan formulary files to analyze changes in coverage policies from 2007 to 2016, and to estimate out-of-pocket spending for DMTs for MS within Medicare Part D program, through which outpatient prescriptions are financed. Eleven DMTs available during the study period were analyzed. Tysabri and Lemtrada were not part of the analysis because they are delivered via intravenous infusion in the clinic setting, and are typically covered through Medicare Part B. Results revealed that the price for Betaseron , Copaxone 20 mg , Rebif, and Avonex ā the four therapies available in 2007 ā quadrupled over the 10-year study period. Except for Copaxone 40 mg and its 20 mg generic formulation (Glatopa, by Sandoz), prices for the other DMTs introduced after 2007 increased by 9ā13% per year. These include Novartisā Extavia (interferon beta-1b) and Gilenya (fingolimod), Biogenās Plegridy (peginterferon beta-1a) and Tecfidera (dimethyl fumarate), and Sanofi Genzymeās Aubagio (teriflunomide). In 2007, 99-100% of plans covered the four available medications, with the exceptions being Rebif (88%). These percentages fell to 54-89% in 2016. Coverage of the other DMTs varied between 21% (Extavia) to 92% for Copaxone 40 mg. In turn, coverage for the three oral options ā Gilenya, Aubagio and Tecfidera ā generally increased or was maintained over time, ranging from 46% for Aubagio to 83% for Gilenya. The use of prior authorization increased from 61-66% in 2007, to 84-90% in 2016. Also, the share of plans with at least one DMT available without limitations declined from 39% to 17%. The average projected out-of-pocket spending for 2019 across DMTs was $6,894. The highest projected out-of-pocket expenses ($8,219) are associated with generic glatiramer acetate, both Glatopa and Mylanās 20 mg/mL and 40 mg/mL generic formulations, approved by the U.S. Food and Drug Administration in 2017. This is more than with any of Copaxoneās formulations. According to the team, this is the result of a higher coinsurance payment (37% vs. 25%) expected for generic medications compared to brand-name options, as well as the fact that manufacturers of generics do not provide discounts toward a beneficiaryās total out-of-pocket spending, unlike what is mandated by the Affordable Care Act for brand-name therapies. āThis is a pernicious effect of the release of a generic and an unfortunate effect of Medicare rules,ā Dennis Bourdette, MD, one of the studyās co-authors, said. A proposal by U.S. President Donald Trump's administration addresses this by eliminating manufacturer discounts from the calculation to determine a patientās total out-of-pocket spending. Such strategy would reduce the disparity between brand-name and generic therapies, the researchers said. āIn this study we found that Medicare beneficiaries with MS who require a [DMT] face considerable policy-related access restrictions and high out-of-pocket spending,ā the researchers wrote. āThere is an urgent need for policies that slow the growth of drug prices, improve access, and shield patients from excessively high out-of-pocket spending,ā they concluded.
February 8, 2019 News by Jonathan Grinstein #ACTRIMS2019 – Upcoming Forum Will Include Interactive, Case-based Discussion About MS Therapeutic Landscape TheĀ Physiciansā Education ResourceĀ will host an interactive, case-based discussion on the latest therapeutics in multiple sclerosis (MS). The free educational program, part of the 2019 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) ForumĀ (Feb. 28 -March 2), aims to inform…
February 7, 2019 News by Larry Luxner Medical Marijuana ‘Can Help Everyone,’ Says Director at Maryland Cannabis Facility Warning the reporter accompanying him not to take any pictures, veteran horticulturalist Michael Castleman punches an electronic code and unlocks the door to Room 209, nicknamed the āMother Room.ā Photography is indeed forbidden inside this living vault, which contains 20 phenotypes of cannabis plants thriving under the glare of 25…
February 7, 2019 News by Jonathan Grinstein Discovery of Immune Cell Subtypes in Mice is an MS ‘Breakthrough,’ Researcher Says Previously unknown immune cell subtypes are present in the inflamed brain of mice models of multiple sclerosis (MS), a new study reports. According to the researchers, these subsets of myeloid cells (cells derived from hematopoietic stemĀ cellsĀ in the bone marrow) can offer a strong basis for therapeutic targets in neuroinflammatory and…
February 7, 2019 News by Vijaya Iyer, PhD Innovation Challenge Invites Applications from Entrepreneurs Affected by MS A collaborative initiative betweenĀ LyfebulbĀ andĀ CelgeneĀ ā called “Addressing Unmet Needs in MS: An Innovation Challenge” ā is inviting applications from U.S.-based entrepreneurs who have multiple sclerosis (MS), or who have been affected by the disease, and whose companies are trying to find solutions to address unmet needs…
February 6, 2019 News by Jonathan Grinstein Traditional Dysphagia Therapy Improves Swallowing Function in MS Patients, Pilot Study Shows Rehabilitation using traditional dysphagia therapy improved swallowing function in multiple sclerosis patients with dysphagia, a pilot study shows. The research article with that finding, āThe effect of traditional dysphagia therapy on the swallowing function in patients with Multiple Sclerosis: A pilot double-blinded randomized controlled trialā was…
February 6, 2019 News by Patricia Inacio, PhD New Research About RhoE Protein Sheds Light on Two Problematic Processes in MS The RhoE protein has been identified as being important for axons’ Ā myelination and extension in the central nervous system, two processes that go awry in diseases like multiple sclerosis (MS). The findings stem from Pilar Madrigalās doctoral thesis, āRole of the small GTPase RhoE in myelination and axonal tracts development.ā…
February 5, 2019 News by Patricia Inacio, PhD Genetic Variants in Inflammasome Genes Influence MS Severity, Progression, Study Suggests Genetic variants that enhance the activity of the NLRP3 inflammasome or the interleukin-1 beta cytokine are linked to higher severity and progression of multiple sclerosis, a study suggests. Previous studies with mouse models of MS have shown that a complex of innate immune system receptors and sensors, known as the inflammasome, is likely a player promoting the immune systemās attack on the central nervous system in MS and, consequently, the loss of myelin. Follow-up studies showed that people carrying mutations that enhance the function of the NLRP3 inflammasome ā one of the three components of the inflammasome complex ā had a worse prognosis, once again supporting the role of the inflammasome in MS. Once activated, the inflammasome triggers an enzyme called caspase-1 that promotes the production of two very powerful proinflammatory cytokines called interleukin (IL)-1 betaĀ and IL-18. To further evaluate the role of the inflammasome in MS, a team led by researchers at the Universidade de Sao Paulo in Brazil analyzed the genetic sequence of five inflammasome genesĀ ā NLRP1, NLRP3, NLRC4, IL-1 beta, and IL-18 ā in blood samples retrieved from 264 patients diagnosed with MS or other demyelinating diseases. They also analyzed 233 healthy individuals used as controls. The team specifically looked at eight variations in certain nucleotides (the building blocks of DNA), called single nucleotide polymorphisms (SNPs). Previous studies reported a link between SNPs in inflammasome-related genes and certain forms of MS. Results showed that SNPs associated with low serum levels of IL-18 were significantly less frequent in MS patients than in controls. In contrast, variants that enhance the function of NLRP3 and IL-1 beta were associated with severity and progression of MS, as measured by the Expanded Disability Status Scale. These results suggest that the "activation of NLRP3 inflammasome could represent a risk factor for MS clinical presentation,ā the researchers wrote. A particular variant in the NLRC4Ā gene was less frequent in patients whose disease progressed rapidly compared with those who had a slower disease, an intriguing observation, according to researchers, suggestive of a āprotection effect of this variant against a bad prognosis.ā Carriers of this variant also responded better to treatment with interferon-beta. Regarding MS type, the genetic variant that promotes the function of theĀ IL-1 beta gene was significantly more frequent in progressive forms of MS than in relapsing-remittingĀ MS, strengthening once again the negative effects of IL-1 beta in the disease. An analysis of inflammasome activity in blood monocytes, a group of immune cells, showed that the inflammasome is permanently activated in MS compared with healthy controls. "This study emphasizes that a constitutive activation of NLRP3 inflammasome, principally through IL-1 beta production, represents a risk factor for both the development of MS and the progression to severe forms of the disease. On the other hand, low IL-18 production and/or NLRC4 activation were beneficial for MS patients,ā the team concluded.
February 5, 2019 News by Jonathan Grinstein MS May Raise Risk of Deep-vein Blood Clots, Possibly by Limiting Mobility, Study Says People with multiple sclerosis may be twice as likely to develop deep-vein blood clots, a condition known as venous thromboembolism, than healthy people do, a study reports. But data linking the two is limited, and its researchers say further work is needed to understand if MS is directly related to…
February 4, 2019 News by Jonathan Grinstein Gait Disorders and Depression at Onset May Delay Time to MS Diagnosis, Study Finds Awareness of certain symptoms, particularly gait disorders and depression, could be critical for reducing the time it takes to diagnose multiple sclerosisĀ after a patient first contacts a healthcare provider, research shows. In the past 30 years, there has been a major decrease in the time from the…
February 4, 2019 News by Iqra Mumal, MSc MS Trust Opens ‘Advanced MS Champions’ Program to Bring Better Care to UK Patients Healthcare specialists forĀ multiple sclerosis patients in the U.K. with advanced disease and challenging needs are getting support and recognition through a new program from the MS Trust. Called theĀ Advanced MS Champions Programme, it will recognize six MS specialist “champions” working with people with advanced MS, and their families…
February 1, 2019 News by Jonathan Grinstein Medication Use in RRMS Patients Highlights Importance of Better Treatment Management, Study Says Patients with relapsing-remitting multiple sclerosis, particularly those with multiple conditions who are more severely disabled, are more likely to be using several medications at the same time, a study shows. These findings highlight the need for physicians to be aware of what medications their patients are taking to avoid…
February 1, 2019 News by Alice MelĆ£o, MSc Study Shows Benefits of Low Temperature Exercise for MS Patients Reducing body temperature during physical exercise can help rewire the brain and improve motor control in patients with multiple sclerosis (MS), a new research study at Canada’sĀ Memorial University shows. Physical exercise can have several benefits for patients with MS, including improved strength and reduced symptoms of fatigue and…
January 31, 2019 News by Jonathan Grinstein Anxiety and Depression Linked to Cognitive Issues in MS, Other Diseases, Study Finds Anxiety and depression are associated with lower cognitive abilities in patients with multiple sclerosis (MS) other and immune-mediated inflammatory diseases such asĀ inflammatory bowel diseaseĀ (IBD) and rheumatoid arthritis, a study shows. These findings indicate the importance of managing symptoms of anxiety and depression in MS, as…
January 31, 2019 News by Alice MelĆ£o, MSc MS Patients Sought to Test Alternative Chronic Pain Treatment Methods A clinical trial funded by the National Multiple Sclerosis Society is recruiting adult patients with multiple sclerosis (MS) to test two non-pharmacological strategies to manage MS-related chronic pain. The trial (NCT03782246) will be conducted at the University of Washington, and plans to enroll about 250 participants across…
January 30, 2019 News by Jonathan Grinstein Canadian RRMS Patients Less Likely to Discontinue Treatment with Oral Gilenya, Compared to Injectable or Infusible Therapies Multiple sclerosisĀ (MS) patients in Canada are more likely to comply with their treatment plan and less likely to discontinue the use of the oral disease-modifying treatment Gilenya (fingolimod), compared to injectable or infusible treatment options, new research shows. The research article with that finding, āA…
January 30, 2019 News by Patricia Inacio, PhD Brain Cells Key to Myelin Grown in Lab and Show Long-Term Survival Essential to Research, Study Reports Stem cells tweaked in the laboratory have allowed researchers, reportedly for a first time, to generate and maintain ball-shaped cultures ā called spheroids ā of human brain cells in 3D that contain oligodendrocytes, the cells that produce myelin, alongĀ with neurons and the astrocytes that are essential to nerve cell health.
January 29, 2019 News by Patricia Inacio, PhD Gilenya Better at Lowering Relapse Rate than Tecfidera or Aubagio, Study Suggests Gilenya is linked to significantly lower annualized relapse rates in relapsing-remitting multiple sclerosis (RRMS) patients compared to Tecfidera orĀ Aubagio, a study suggests. All three therapies showed similar effects on disability outcomes. Oral immunotherapies ā including Novartisā Gilenya, Biogenās Tecfidera, and Sanofi Genzymeās Aubagio ā are currently standard therapies for RRMS treatment. But while these therapies are highly effective at modulating MS activity, studies comparing their efficacy on relapse and disability are missing. This is an important point for MS patients, so that if a change in oral therapies is needed (due to lack of tolerance, for example), the decision on a more suitable therapy is based on scientific evidence. To address this matter, a group of researchers used the MsBase, an international observational MS cohort study, to identify RRMS patients who had been treated with Gilenya, Tecfidera, or Aubagio for at least three months. The team compared Tecfidera versus Aubagio, Gilenya versus Aubagio, and Gilenya versus Tecfidera, specifically for the therapyās impact on relapse activity, six-month disability worsening or improvement, and persistence of treatment. Relapse was defined as the occurrence of new symptoms or exacerbation of existing ones for a period of over 24 hours, at least 30 days after a previous relapse. Disability was assessed using the Expanded Disability Status Scale (EDSS); the six-month disability worsening or improvement were defined as an increase or a decrease by one value in EDSS. The study included 614 patients treated with Aubagio, 782 with Tecfidera, and 2,332 with Gilenya. Patients were followed over a median of 2.5 years. Patientsā characteristics at baseline differed among the three groups. Aubagio-treated patients tended to be older, with longer periods of disease, fewer relapses, and lower EDSS scores compared to the other two groups. Patients treated with Gilenya had higher EDSS and more relapses during the prior year, compared to those treated with Tecfidera. The majority of the patients had been treated with other immunotherapies prior to being given one of these three oral treatments. Results showed that Gilenya-treated patients had significantly lower annualized relapse rates than those treated with Tecfidera (0.20 versus 0.26) or Aubagio (0.18 versus 0.24), while patients taking either Tecfidera or Aubagio had a similar rate. However, during the 2.5-year period analyzed, researchers found no differences in disability accumulation or disability improvement among the three therapies. Regarding treatment persistence, Tecfidera and Aubagio were more likely to be discontinued than Gilenya. Overall, the results suggest that treatment with Gilenya may have a greater impact on relapse frequency in RRMS patients compared to Tecfidera and Aubagio, although the "effect of the three oral therapies on disability outcomes was similar during the initial 2.5 years on treatment," researchers said. āChoosing a therapy in individual patients remains a complex task that requires thorough and individualized evaluation of disease prognosis, and the corresponding risks and benefits of the increasing number of available therapies,ā they concluded.
January 29, 2019 News by Santiago Gisler Funding Supports MS Research on Epigenetics and Fatigue in Australia Australian researchers from the University of NewcastleĀ andĀ the Hunter Medical Research Institute (HMRI) have received funding for two projects that will study unexplored areas in multiple sclerosis (MS). The projects, investigating the role of epigenetic differences in MS severity and treatment against MS-derived fatigue, received $211,000 AUD (about $151,300…
January 28, 2019 News by Jonathan Grinstein Decline in Brain Volume Driven by Gray Matter Atrophy in MS Patients Despite Tysabri Treatment The progressive decline in brain volume in multiple sclerosisĀ (MS) patients, despite treatment with the disease-modifying therapyĀ Tysabri (natalizumab), is driven by atrophy ā shrinkage due to the degeneration of cells ā in gray matter and not white matter structures, a new study reports. This finding points to new markers…
January 28, 2019 News by Jonathan Grinstein Altered Oligodendrocyte Diversity Contributes to Multiple Sclerosis, Study Suggests Subpopulations of oligodendrocytes ā cells that produce the myelin sheath that protects nerve fibers ā are altered in patients withĀ multiple sclerosis, a study shows. These findings suggest that oligodendrocyte diversity and the different functions of these subpopulations might have a greater role in the disease than previously thought. The severity of MS varies greatly, and the patient's disability level does not correlate well with the degree of myelin loss. This suggests that other factors contribute to MS severity. One such factor may be that oligodendrocytes are heterogeneous ā diverse in makeup and function. For example, oligodendrocytes in mouse spinal cords are known to naturally produce longer myelin sheaths than oligodendrocytes in the mouse brain. Additionally, individual oligodendrocytes have been shown to have different molecular makeups. However, the extent of human oligodendrocyte diversity and its possible contribution to MS pathology remains unknown. Researchers from the Karolinska Institutet and the MRC Centre for Regenerative Medicine studied the differences of individual human oligodendrocytes from healthy and MS brains to assess their diversity. Specifically, the team examined oligodendrocytes from the white matter areas of post-mortem human brains both from MS and non-MS patients. The team examined the RNA content ā the messenger molecule carrying instructions from DNA for the production of proteins ā from individual oligodendrocytes. Researchers identified groups of RNA molecules that defined features of oligodendrocytes from healthy human white matter. Some of these groups match those that defined oligodendrocytes in healthy mice. Strikingly, some of these RNA molecules in healthy brains were under-represented in oligodendrocytes from MS brains, whereas others were more prevalent. āWe found that oligodendrocytes are a diverse population of cells and that different types are likely to have different functions in the brain,ā Charles ffrench-Constant, the study's co-lead author, said in a Karolinska InstitutetĀ news release written byĀ Katarina Sternudd. These differences in oligodendrocyte RNA content may indicate different functional states of oligodendrocytes in MS lesions. āThe proportions of different resident oligodendrocytes in the lesions are changed, along with their properties, suggesting that they might have important roles in MS,ā said Eneritz Agirre, PhD, a study co-author. Furthermore, the researchers believe that this altered diversity in oligodendrocytes in MS may be important to understand disease progression and develop therapeutic approaches. āUnderstanding which types of oligodendrocytes are most beneficial in repairing myelin will be crucial for maximizing the chances of developing much-needed treatments for MS,ā said Anna Williams, PhD, study co-lead author. The team concluded that theĀ changes in different oligodendrocyte subpopulations in MS suggest "a more complex role of these cells in the pathology of the disease, but also in regeneration of new cells,ā said GonƧalo Castelo-Branco, PhD, another study co-lead author.
January 28, 2019 News by Jose Marques Lopes, PhD Tiny Cell Membrane Disruptions Lead to Nerve Fiber Degeneration in MS, Mouse Study Suggests Tiny ruptures in the cell membrane of nerve fibers enable the entry of calcium and ultimately lead to their degeneration, a study in a mouse model of multiple sclerosis (MS) suggests. The study, āCalcium Influx through Plasma-Membrane Nanoruptures Drives Axon Degeneration in a Model of Multiple…
January 25, 2019 News by Jose Marques Lopes, PhD Chi3l3 Protein Favors Production of Myelin Repair Cells, Mouse Study Determines A protein marker for activated immune cells called Chi3I3 is key for the production of myelin-forming cells, and may become a target to boost myelin repair in multiple sclerosis (MS), according to a new study. The research, āChi3l3 induces oligodendrogenesis in an experimental model of autoimmune…
January 25, 2019 News by Jonathan Grinstein Positive Safety Data Reported for High-dose MS Treatment Candidate Temelimab GeNeuroĀ has reported positive data from a Phase 1 clinical trial (NCT03574428) evaluating the safety and tolerability of high doses ofĀ GNbAC1, developed for the treatment of neurological and autoimmune disorders, includingĀ multiple sclerosis (MS). The company also announced that the World Health…
January 24, 2019 News by Patricia Inacio, PhD Study of Myelin Debris Sheds Light on Brain Inflammation in MS Endothelial cells, those lining the inside of small blood vessels, promote clearance of myelin debris ā a common detrimental outcome of demyelinating diseases such as multiple sclerosis (MS) or spinal cord injury. However, in its path to clear the brain from myelin debris, endothelial cells trigger more damaging mechanisms, promoting…
January 24, 2019 News by Jonathan Grinstein New Products Intended to Stimulate Feet of MS Patients Naboso TechnologyĀ has expanded its product offerings with new insoles and training mats specifically designed to stimulate the nervous system through the skin on the bottom of the feet. The products were developed to help improve balance, posture, movement and restore motor function, as part of aĀ neurorehabilitation strategy…
January 23, 2019 News by Jonathan Grinstein Novartis, Oxfordās Big Data Institute Team to Better Understand, Treat Complex Diseases NovartisĀ and the University of Oxfordās Big Data Institute (BDI) have established an alliance to advance the use of medical data for spotting disease patterns and assessing patients’ responses to treatment. The initiative seeks to enable more informed clinical decision-making and improve the development of treatments for complex diseases.
January 23, 2019 News by Jose Marques Lopes, PhD Favorable Efficacy and Similar Safety with Ocrevus in Relapsing MS, Study Finds Treatment with Ocrevus (ocrelizumab) has superior or comparable effectiveness and a similar safety profile to other available disease-modifying treatments (DMTs) for treating relapsing multiple sclerosis (MS), according to a new review study. The research, āSystematic review and network meta-analysis comparing ocrelizumab with other treatments for…