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A large Phase 3 trial getting underway at sites across the U.K. will test the effectiveness of simvastatin, a widely used oral statin, in possibly treating secondary progressive multiple sclerosis (SPMS), the study’s sponsor, University College of London Hospitals (UCLH), announced. The study, the largest ever undertaken for SPMS…

Phagocytes, diverse cells of the innate immune system, are known to both promote and prevent inflammation, depending on whether they are programed to damage tissue or to repair it. A study in mouse model of multiple sclerosis (MS) now reports that this programming is not fixed, and that pro-inflammatory…

Cassandra Jefferson of Chattanooga, Tennessee, didn’t want to put her mother, who has multiple sclerosis, in a nursing home, but she had begun to realize that she might have no choice. The required care was getting to be too much for Jefferson, who worked long hours before rushing home to…

Treating primary progressive multiple sclerosis patients with Ocrevus (ocrelizumab) led to a three-fold increase in the proportion of those showing no evidence of disease progression and no signs of inflammatory disease activity over more than two years of treatment, results of a Phase 3 trial show, and support new measures that might better capture disability in PPMS patients. The research, “Evaluation of No Evidence of Progression or Active Disease (NEPAD) in Patients With Primary Progressive Multiple Sclerosis in the ORATORIO Trial,” was published in the journal Annals of Neurology. Measuring disease progression in clinical trials and clinical practice requires reliable and comprehensible measures. Although widely used, the Expanded Disability Status Scale (EDSS, range 0-10) cannot fully capture changes in walking speed and hand or arm function, which are key determinants of overall disability in progressive forms of MS. No evidence of progression (NEP) is a newer measure that reflects the absence of disability progression, including upper limb function and walking speed. Maintaining NEP status means stable disease with no worsening in EDSS, in walking ability (assessed by the Timed 25-Foot Walk (T25FW) test, or the time it takes to walk 25 feet as quickly and safely as possible), and in upper limb function (assessed by the 9-Hole Peg Test (9HPT), a test of arm and hand dexterity). Patients with PPMS have less frequent signs of disease activity, which include relapses and brain lesions (assessed though magnetic resonance imaging or MRI). So scientists proposed a new measure — called “no evidence of progression or active disease” (NEPAD) — to evaluate both NEP and clinical and MRI measures of active disease. The researchers believe that NEPAD may represent a more sensitive and comprehensive measure of disease control in PPMS patients. The randomized, double-blind ORATORIO Phase 3 trial (NCT01194570) analyzed the efficacy and safety of Ocrevus — developed by Genentech, part of the Roche group — in 732 PPMS patients (age range 18–55). Results showed that Ocrevus treatment delayed the relative risk of disability progression by 25% compared to placebo, while also reducing the volume of chronic brain lesions and total brain volume loss. As a result, Ocrevus became the first therapy approved by the U.S. Food and Drug Administration and the European Commission for both PPMS and relapsing MS. Now, researchers assessed Ocrevus’ effect in PPMS patients included in the Roche-funded ORATORIO study using as trial goals changes in NEP and NEPAD. These people received either 600 mg of Ocrevus or placebo by intravenous (IV) infusion every six months for a minimum of 120 weeks (about 2.3 years). The trial’s main goal was time to onset of clinical disability progression (CDP) sustained for at least 12 weeks. CDP was defined as a 1.0 point or greater increase in EDSS score from a baseline (study start) score of 5.5 or less, or a 0.5-point increase from a baseline score greater than 5.5. NEP status, analyzed in 230 placebo- and 461 Ocrevus-treated patients, was defined as no evidence of CDP for 12 weeks, no 20% or more change in hand/arm function as measured by the 9HPT for 12 weeks, and no 20% or more change in walking ability as measured by the T25FW test for 12 weeks. "The 20% cut-off for progression on the T25FW test and the 9HPT has previously been shown to be a clinically meaningful magnitude of disease progression," the study noted. In turn, NEPAD — assessed in 234 placebo- and 465 Ocrevus-treated patients — included NEP, no brain MRI-measured disease activity, and no relapses. Relapses were defined as new or worsening neurological symptoms attributable to MS lasting longer than 24 hours and preceded by neurological stability for a minimum of 30 days. Brain MRI scans were conducted at baseline, and weeks 24, 48, and 120; new or enlarging T2 lesions and/or T1 enhancing lesions were considered evidence of MRI disease activity (T1 MRI imaging offers information about current disease activity by highlighting areas of active inflammation, while a T2 MRI image provides information about disease burden or lesion load). Overall, the majority of the PPMS patients analyzed experienced clinical disease progression or evidence of disease activity. From baseline to week 120, Ocrevus-treated patients who achieved NEP (42.7% of 461 people) or NEPAD (29.9% of 465)  — no disease activity or progression — were found to have lower T2 brain lesion volume and a lower EDSS score (lesser disability) compared to those with evidence of MS progression. They also had a slightly superior performance on the 9HPT and the T25FW test. Patients who reached NEPAD also showed fewer T1 lesions than patients with progressing or active disease. Compared to placebo treatment, the proportion of Ocrevus-treated PPMS patients maintaining NEP or NEPAD from baseline to week 120 was higher — for NEP, 42.7% versus 29.1% in the placebo group; for NEPAD, 29.9% versus 9.4% in the placebo group. These results showed that Ocrevus treatment increased the proportion of PPMS patients with NEPAD throughout the 120 weeks of the study by three-fold. “In conclusion, ocrelizumab (Ocrevus) increased the proportion of patients with PPMS with no evidence of progression and no clinical and subclinical disease activity compared with placebo,” the team wrote. “As such, NEPAD may represent a meaningful and comprehensive disease outcome in patients with PPMS.” However, data from ORATORIO's open-label extension and real-world data are needed to "determine whether NEPAD maintained throughout 120 weeks will translate into sustained NEPAD and enhanced protection against accrual of disability in patients with PPMS over the long term," the researchers concluded. Of note, five of the study’s 11 authors are employees and/or shareholders of Roche or Genentech.

Apolipoprotein D (Apo D), a brain-produced carrier of fat molecules, seems to have a neuroprotective role and helps in the regrowth of myelin during multiple sclerosis (MS), a finding that may help develop new therapeutic approaches to fight the disease, new research shows.

The National Institute for Health and Care Excellence, better known as NICE, issued a final decision against including Ocrevus (ocrelizumab) as a treatment for primary progressive multiple sclerosis (PPMS) in the subsidized public health system for England and Wales. The agency’s “final appraisal,” which mirrors its draft…

A study of Iranian patients with early-onset multiple sclerosis (MS) found women to be in the majority, optic neuritis to be the most common first disease symptom, and relapsing-remitting MS the most frequent disease course. The epidemiology of early-onset MS (typically, MS diagnosed before age 16; age 18 was the benchmark…

Multiple sclerosis (MS) that appears to be "genuinely benign" 15 years after diagnosis is evident in a small number of patients, a large population-based study from the U.K. reports. But, its researchers note, the term “benign” is often not clinically accurate as used, because it is based largely on perceptions of disease impact. The study “How common is truly benign MS in a UK population?” was published in the Journal of Neurology, Neurosurgery & Psychiatry. The concept of benign MS is controversial, especially among clinicians. Still, long-term epidemiological studies have consistently identified a small fraction of patients whose MS progresses very slowly over a long span of years. Determining the prevalence of this type of MS in the population has been difficult, as estimates can vary significantly depending of the definition of “benign” that is adopted. Researchers sought to determine an accurate estimate of benign MS in the U.K. population, using a rigorous and comprehensive clinical definition of a truly benign disease. This definition included minimal physical disability (EDSS score of less than 3), and no significant fatigue, mood disturbance, cognitive impairment or interrupted employment in the absence of treatment with disease-modifying therapies over 15 years or more years after symptom onset. They screened an U.K. population-based registry containing data on 3,062 MS patients to identify those with "unlimited walking ability" 15 or more years after diagnosis. A representative sample of 60 patients  from this pool was analyzed (45 women and 15 men, mean age of 57); they had a mean disease duration of 28 years. Nine out of these 60 (15%; 8 women and one men) fulfilled the study’s criteria for truly benign disease. These nine people had a mean age of 27 at symptom onset, a median EDSS disability score of 1.5 (minimal signs of disability), and a mean disease duration of 31 years. "Those nine individuals with truly benign MS all remained in a relapsing–remitting state," the study noted. "However, only two out of nine showed disease arrest within the first decade; the remainder all continued to experience relapses well into their second or third decade of MS," but the rates of such relapses were low. MS in the remaining patients was not classified as benign, mostly due to evidence of cognitive difficulties (57%), and the disease's impact on employment status (52%) with many taking early retirement. Based on these results, a population frequency for "benign MS" under the definitions used was estimated at 2.9%. But the researchers noted that a large proportion of patients (65%; 39 patients out of 60) reported their disease as benign, according to a lay definition. Their self-reported status poorly agreed with the clinical assessments done throughout the study. "There is no accepted definition to offer patients when exploring whether they feel their MS is benign; the definition we chose incorporates the fundamental principles of low impact on a person, absence of complications and a favourable outcome and is in line with definitions provided by third-party support groups," the researchers wrote. Many  considering themselves with benign disease did so based on their "perception" of their disease, the team added, and one that "appeared to be driven as much by mood, fatigue and bladder function as by physical ability."  “In conclusion, after detailed clinical assessment, a small minority of people with MS appear genuinely unaffected by symptoms after 15 years,” the researchers added. They also called attention to the fact that EDSS-based definitions of benign MS and the inconsistency between patient and clinician perception of benign MS compromise the use of the term ‘benign’ in clinical practice. They also emphasize that studying individuals with benign MS “has the potential to uncover clues to mechanisms underlying favorable outcomes in MS, provide insights into new therapeutic targets and have implications for patient counselling, individual patient management and the construct of clinical trials.”

Parents of children with pediatric-onset multiple sclerosis (MS) report a lower overall quality of life than those whose kids have a condition marked by demyelination but is not a chronic disease, a study reports. The lifelong nature of MS makes all the difference, it said. MonoADS, like MS, is caused by…

Gender differences are evident in immune system cells of the brain called microglia, a study in male and female mice reports, suggesting these cells’ sex-specific features may be important to treating people with  multiple sclerosis (MS) and other neurological diseases. The study “…

Active Biotech announced it has regained global development and commercialization rights over laquinimod, its investigational oral therapy for multiple sclerosis (MS), from Teva Pharmaceuticals. Teva released rights to laquinimod after the company decided not to continue with its clinical development. Teva will give Active Biotech full…

B-cells in the immune system play an important role in the unfolding of inflammation and brain lesions in multiple sclerosis (MS), largely by how they influence the actions of another immune system cell, called T-cells, a new study reports. Its findings help explain why therapies…

Tysabri (natalizumab) was reported in a small retrospective study to significantly improve cognitive abilities in people with relapsing-remitting MS patients (RRMS) over two years of use. The study, “Improvement in Cognitive Function as Measured by NeuroTrax in Patients with Relapsing Multiple Sclerosis Treated with Natalizumab: A 2-Year…

Sexual problems are a frequent but unreported symptom of multiple sclerosis (MS) that affects other symptoms patients experience with this disease, including depression, a study reports. The study, “Factors associated with sexual dysfunction in individuals with multiple sclerosis,” published in the International Journal of MS Care. Sexual dysfunction is…

A meta-analysis of 13 case-control studies shows that the levels of the protein neurofilament light chain (NFL) are significantly higher in both the cerebrospinal fluid and blood of multiple sclerosis (MS) patients, compared to healthy controls. This finding adds to previous evidence supporting the usefulness of NFL as a…

Adults in Ireland with highly active relapsing multiple sclerosis (MS) now can be treated with Mavenclad (cladribine tablets, 10 mg), the first short-course oral treatment approved for this disease. The Irish Health Service Executive (HSE) has approved this new therapy and decided to reimburse patients for its associated…

Spasticity scales may be insufficient to reflect the actual benefits of Sativex (nabiximols) treatment on spasticity symptoms in people with multiple sclerosis (MS), according to a small case series study. The results support the need to conduct a more extensive and functional examination to clarify treatment responses and help…

Cigarette smoking worsens shortness of breath and fatigue, increases the rate of hospital admissions, and fosters a sedentary lifestyle in patients with multiple sclerosis (MS), according to a new study. The research, “Effects of cigarette smoking on respiratory problems and functional levels in multiple sclerosis patients,”…

A&W Food Services of Canada, a chain of hamburger restaurants, in partnership with the Multiple Sclerosis Society of Canada, raised more than $1.9 million at its 10th annual “Burgers to Beat MS” campaign Aug. 16. This is the largest amount the campaign has raised. To celebrate Burgers to Beat MS campaign,…

Cerebrospinal fluid of progressive multiple sclerosis (MS) patients may carry lower levels of cell-free mitochondrial DNA, according to a team of researchers who say this may be a sign of neurodegeneration among these patients. The study “Cell-free mitochondrial DNA in progressive multiple sclerosis” was published in the journal Mitochondrion.

Tecfidera (dimethyl fumarate) and Gilenya (fingolimod) are equally effective in treating multiple sclerosis (MS), but Tecfidera shows higher rates of discontinuation, according to a real-world study. The study, “Discontinuation and comparative effectiveness of dimethyl fumarate and fingolimod in 2 centers,” was published in the journal Neurology Clinical…

Researchers at Duke University are recruiting adults with multiple sclerosis (MS) for a study evaluating whether the use of a smartphone app that collects data can help capture the disease experience, improve communication with clinicians, and further an understanding of MS. The disease’s complex and varied symptoms means each patient…

A small synthetic molecule called TDP6 mimics a natural growth factor and promotes myelin regeneration in a mouse model of demyelination diseases such as multiple sclerosis (MS), a new study from Australia shows. TDP6 works by targeting a receptor at the surface of myelin-producing cells called oligodendrocytes. The study, “…

Poor sleep quality is very common among patients with relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS), and is associated with a lower quality of life, and greater fatigue, depression and anxiety, according to a real-world study in patients treated with Betaferon (interferon beta-1b). The study, “…

Physical exercise fights fatigue and depression in patients with multiple sclerosis (MS), a new study reveals. Remarkably, these positive outcomes in psychological health can be achieved without significant alterations in the patient’s body weight or body mass index (BMI), further supporting the idea that exercise could be…

MMJ International has filed two applications with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical studies testing its pharmaceutical grade cannabis-based therapies in easing symptoms associated with multiple sclerosis and Huntington’s disease. “The filing of these applications with the FDA brings us one step…

Gilenya (fingolimod) influences the release and function of small membrane particles, called extracellular vesicles, that are involved in the development of multiple sclerosis — and these vesicles may serve a biomarker of treatment effectiveness in people with relapsing MS, researchers report. Extracellular vesicles (EVs) may also work…

Abreos Biosciences announced the U.S. launch of moNATor, a laboratory-developed test that can help physicians monitor the levels of Tysabri (natalizumab) in patients with multiple sclerosis (MS). Tysabri (approved for relapsing forms of MS, by Biogen) administered at a dose of 300 mg every four weeks is known to be…

Non-psychoactive cannabidiol (CBD), one of the active compounds in medical cannabis, significantly reduced clinical signs of multiple sclerosis (MS)-like disease in an experimental autoimmune encephalomyelitis mouse model. Researchers found that CBD promoted the increase of inflammatory-suppressor cells called myeloid-derived suppressor cells. The findings were reported in the study “Cannabidiol Attenuates Experimental Autoimmune…

Carmen Navarrete, PhD, has been granted a Scientific Innovation Award for her post-doctoral presentation suggesting that the multiple sclerosis (MS) treatment candidate EHP-101 is anti-inflammatory and may boost remyelination, Emerald Health Pharmaceuticals announced. Navarrete, a senior scientist at Vivacell Biotechnology Espana, a company owned by Emerald Health Research, received the award at the…