treatment

A brain training technique that helps boost processing speed was seen to significantly improve the cognitive capacity of multiple sclerosis (MS) patients, as well as their ability to perform everyday activities, a pilot study shows. The study, “A Pilot Study Examining Speed of Processing Training (SPT) to Improve…

Eighteen months after its entrance into the U.S. market, Genentech’s Ocrevus (ocrelizumab) has become the monoclonal antibody of choice to treat patients with multiple sclerosis (MS), according to a survey of nearly 100 neurologists across the U.S. Self-reported use of Ocrevus for the third quarter of 2018 surpassed…

Treatment with Rapacan (rapamycin) decreased the size and volume of brain lesions in patients with multiple sclerosis (MS), an Iranian study reports. The study, “Promising effect of rapamycin on multiple sclerosis,” was published in the journal Multiple Sclerosis and Related Disorders. Rapamycin, or sirolimus, is an immunosuppressive…

Lymphatic vessels, the “roads” that work to clear waste material from the brain, can also carry messages that direct immune system attacks against myelin, promoting the onset of multiple sclerosis (MS), new study shows. While the identity of these messages remains unknown, the findings suggest that blocking these signals could…

GeNeuro announced it has reacquired from Servier the worldwide rights to commercialize and develop the investigational humanized antibody GNbAC1 for the treatment of multiple sclerosis (MS). The decision came after Servier, a European company which, together with GeNeuro, developed the GNbAC1 program, declined to continue developing the therapy due to…

The synthesis and metabolism of fat molecules known as ceramides is linked to G-CSF signaling, which increases white blood cell infiltration into the central nervous system and results in inflammation in patients with multiple sclerosis (MS), a new study shows. The study titled, “The relevance of ceramides and their…

Editor’s note: Shortly after this column was published, Mylan pharmaceuticals announced it will begin distributing Dalfampridine Extended-Release Tablets, 10 mg, the authorized generic version of Acorda’s Ampyra. There’s been no word, yet, on what it will cost or how soon the generic will become available in pharmacies. A few…

The Multiple Sclerosis Society of Canada and the Multiple Sclerosis Scientific Research Foundation have awarded a $410,000 grant to fund research based on a new method for treating cognitive dysfunction in patients with progressive multiple sclerosis (MS). About 70% of progressive MS patients suffer from cognitive abnormalities that…

Remyelination therapies are on the horizon as an innovative multiple sclerosis (MS) treatment, according to my neurologist. These therapies have been on my radar the last few years, but to hear my neurologist say they could soon be a reality makes me hopeful of the possibilities. To offer a…

Two years of treatment with oral Gilenya (fingolimod) significantly reduced the rate of relapses when compared to Avonex (interferon beta-1a) intramuscular injections in children and adolescents with relapsing forms of multiple sclerosis (RMS), according to Phase 3 clinical trial results. Additionally, Gilenya (marketed by Novartis) decreased the number of central nervous…

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…

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.

Third in a series. Read parts one and two. In March 2018, I began a personal research project — quest if you will — to assess how functional electrical stimulation (FES) devices might help me deal with the foot drop in my…

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…

The start of flu season here in the United States is just a few weeks away. It’s time for my wife and me to get our flu shots, just as we have for as long as I can remember. My neurologist and our primary care physician both recommend the…

How B-cells Work to Promote T-cell Attacks on Myelin That Lead to MS Detailed in Study I keep a close eye on reports about B-cells and T-cells because they’re the targets of Lemtrada, which is my current disease-modifying therapy. (The DMT Ocrevus targets B-cells alone). So, this…

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…

Medical tourism is a term describing when people seek medical care by traveling from home countries to somewhere else. It’s an area of commerce that has existed for centuries, as people in ancient Greece once traveled to far away islands to visit healing gods. Medical tourism continues today, and…

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…

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…

Ocrevus, a disease-modifying MS treatment that’s only been on the market a little less than 18 months, appears poised to be a cash cow for its maker, Genentech. The research firm Spherix Global Insights, which analyzes trends in the pharmaceutical industry, predicts that Ocrevus is “poised to…

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…

Medical cannabis has created a dilemma for medical providers who care for people who might benefit from its use. I’ve been thinking more about this lately because my home state of Ohio will have legal medical marijuana dispensaries starting on Sept. 8. The law passed in 2016, and it…

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…

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, “…

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…