RRMS

Treatment with Lemtrada (alemtuzumab) is associated with the death of patients with relapsing-remitting multiple sclerosis (RRMS) more often than previously reported and appears to be most common during the first month, according to a European review. The study, “Adverse events with fatal outcome associated…

Treatment with rituximab — sold as Rituxan in the U.S. by Roche and Biogen, and as MabThera by Roche in Europe — reversed disease course in a “dramatic fashion,” leading to complete remission in a 12-year-old boy with aggressive relapse-remitting multiple sclerosis (RRMS), a case report states. The report, “…

Interleukin-17A (IL-17A), a molecule that mediates immune and inflammatory responses, likely promotes inflammation and tissue damage in relapsing-remitting multiple sclerosis (RRMS) and should be considered a potential target for treating the disease, a study reports. The findings of the study, “IL-17A is associated with the breakdown of the…

No excessive relapse risk appears to exist for people with multiple sclerosis who undergo surgery that requires anesthesia, researchers report, challenging long-held assumptions associated with MS and surgery. Their single-site study, “Multiple sclerosis relapse risk in the postoperative period: Effects of…

Routine screening through magnetic resonance imaging (MRI) of people with multiple sclerosis (MS) can predict long-term disease progression — leading to more certainty and informing better treatment choices, a 15-year study reported. The study, titled “Early imaging predictors of long-term…

A clinical trial based at the Cleveland Clinic and the University of Nottingham, U.K., is recruiting patients with relapsing-remitting multiple sclerosis (RRMS) to compare two treatment strategies, the National Multiple Sclerosis Society announced. The Phase 4 study, called DELIVER-MS (NCT03535298), intends to enroll about 800…

Obesity, altered lipid (fat) levels, and elevated leptin — an hormone produced by fat cells — may contribute to neuroinflammation, and worse disease severity in people with relapsing-remitting multiple sclerosis (RRMS), research has found. A study with the findings, titled “Obesity worsens central inflammation and disability in multiple…

Vumerity (diroximel fumarate), taken as a 462 milligram (mg) tablet twice daily, significantly decreases disease activity in patients with relapsing-remitting multiple sclerosis (RRMS), and leads to low rates of gastrointestinal side effects, new interim data of Phase 3 trial EVOLVE-MS-1 show. The findings were presented at the 2019 Consortium…

Oral Gilenya (fingolimod) taken daily at a 0.5 mg dose is superior to Copaxone (glatiramer acetate) injections at lowering relapses and disease activity over one year in patients with relapsing-remitting multiple sclerosis (RRMS), according to results of a Phase 3b trial. The research, “Efficacy and Safety…

Two ongoing clinical trials may help doctors better understand which type of disease-modifying therapy — those considered highly effective or those with low-to-moderate efficacy used in an escalating treatment approach — would be best for people in the early stages of  relapsing-remitting multiple sclerosis (RRMS), according to a  …

Patients with relapsing-remitting multiple sclerosis (RRMS) who switched to infusions with Sanofi Genzyme’s Lemtrada (alemtuzumab) report increased satisfaction with treatment and improvements in health-related quality of life, according to…

A newly developed scoring tool enables better identification of patients with relapsing-remitting multiple sclerosis (RRMS) as well as those transitioning or already diagnosed with secondary progressive MS (SPMS). The research about that finding, “Validation of the Scoring Algorithm for a Novel Integrative Secondary Progressive Multiple Sclerosis (SPMS) Screening Tool,”…

New data suggests that treatment with Tysabri (natalizumab) in an extended interval dosing regimen is associated with a significantly lower risk of progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis (MS), compared with the standard interval dosing. The data was presented by Lana Zhovtis Ryerson, MD, on May 7 at the 2019 …

In clinical practice, relapse events dropped by roughly half over a four-year period in relapsing-remitting multiple sclerosis (RRMS) patients treated with Aubagio (teriflunomide), a real-world study reports. The study, “Real-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study,” also examined patients’ perspectives in…

Cognitive and neuropsychiatric problems caused by relapsing-remitting multiple sclerosis (RRMS) — such as memory and processing issues, depression, and irritability — are the main source of strain among life partners of MS patients with mild disability, a study finds. The study, “Caregiver strain among life partners…

Tecfidera (dimethyl fumarate) is more efficient at preventing relapses, and has a lower discontinuation rate than Aubagio (teriflunomide), according to a Danish study. The study “Comparative effectiveness of teriflunomide and dimethyl fumarate: A nationwide cohort study” was published in the journal Neurology. Aubagio (marketed by Sanofi Genzyme) and Tecfidera…

National organizations that represent patients with multiple sclerosis (MS) welcome the U.S. Food and Drug Administration’s March 26 approval of Novartis’ oral therapy Mayzent (siponimod) — but they complain that, at $88,500 per year, the treatment is overpriced. The Multiple Sclerosis Society of America (MSSA) is clearly upbeat about the…

Roche Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) have completed negotiations ultimately aiming to obtain public funding for Ocrevus (ocrelizumab) as a first-line treatment for adults with relapsing-remitting multiple sclerosis (RRMS) with active disease, and as management strategy for patients with early primary progressive MS…

The Cleveland Clinic Nevada is recruiting participants for DELIVER-MS, a clinical trial comparing two common treatment approaches for relapsing-remitting multiple sclerosis (RRMS). Results from the DELIVER-MS trial, titled “Determining the Effectiveness of Early Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis” (…

An application has been submitted for the use of ozanimod to treat adult patients with relapsing-remitting multiple sclerosis (RRMS) within the European Union, according to Celgene, the developer of ozanimod. The marketing authorization application was submitted to the European Medicines Agency…

Immunic Therapeutics has enrolled the first patient in its Phase 2 clinical trial testing IMU-838, a potential oral therapy for relapsing-remitting multiple sclerosis (RRMS). IMU-838 (vidofludimus calcium) is a next-generation selective modulator of the immune system. It works by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which plays a role…

A daily cup of flavonoid-rich cocoa may help ease fatigue in people with relapsing-remitting multiple sclerosis (RRMS), according to the results of a small clinical trial. The study “A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis” was…

Evobrutinib, Merck KGaA’s oral candidate for relapsing multiple sclerosis (MS), is safe and can significantly reduce active brain lesions over 24 weeks of treatment, results of ongoing Phase 2 study show. Xavier Montalban, PhD, MD, with Vall d’Hebron University Hospital in Barcelona, presented the results in the talk “Primary…

Ocrevus (ocrelizumab) was shown to be a highly effective therapy for people with multiple sclerosis (MS) in real-world clinical practice, according to Brandon Moss, MD, from the Cleveland Clinic. The data was presented in a poster session Feb. 28, at the Americas Committee…

The rate of spinal cord tissue loss is a strong indicator of conversion from relapsing-remitting multiple sclerosis (RRMS) to secondary progressive MS (SPMS), according to a finding presented at the fourth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2019. The forum…

Vitamins B12 and B9 (folic acid) supplements can lower levels of homocysteine (a common amino acid), improve anemia status, and boost self-reported physical health in patients with multiple sclerosis, according to new research. The study suggests a potential role for these two vitamins in improving the quality of life of MS patients. Despite treatment, MS patients often experience symptoms that interfere with their daily lives. Many patients have turned to dietary supplements with the hope they would reduce the severity of their symptoms. There is substantial literature suggesting the benefits of various supplements for MS, including vitamin B12 and folic acid. Homocysteine, of which high levels are associated with heart disease and detrimental effects in the nervous system, can be more prevalent in MS patients compared to healthy individuals. That suggests homocysteine is "one of the causative factors in the pathogenesis [development] of MS," researchers wrote. Lack of vitamin B12 — naturally found in meat, fish, poultry, eggs, and dairy products — can lead to a disruption in myelination, the process of forming a protective myelin coat around nerve cells. The loss of myelin is a hallmark of MS. A lack of folic acid, together with too little vitamin B12, has been linked to neurological symptom onset in MS patients. Meanwhile, vitamin B12 and folic acid supplements have shown promising results among these patients. In addition, MS patients are known to have an increased risk for the development of megaloblastic anemia — a condition in which the bone marrow produces unusually large, immature red blood cells referred to as megaloblasts. The most common causes of megaloblastic anemia are a deficiency of either vitamin B12 or folic acid. Based on these observations, researchers from Urmia University of Medical Sciences and Kermanshah University of Medical Sciences, in Iran, studied the effects of vitamin B12 and folic acid supplements in  relapsing-remitting multiple sclerosis (RRMS) patients. The team looked specifically at serum homocysteine levels, anemia status, and quality of life. This double-blinded clinical trial (IRCT2015100313678N7) enrolled 50 RRMS patients (age 20-40 years), who were divided into two groups: the vitamin group, which received three doses of 1 mg vitamin B12 injection (spaced a month apart) plus 5 mg folic acid tablets daily; and the placebo group, which received neutral saline injections. All participants completed two quality-of-life questionnaires, one geared toward physical health and the other toward mental health, at the start and end of the study. Blood samples were collected from all participants, and blood pressure readings were taken. Results showed a drop in average homocysteine blood serum levels in the vitamin group, which may be indicative of an improvement in nervous system health. Researchers also observed a decrease in mean corpuscular volume (MCV) in the vitamin group, which is indicative of improved anemia status. At the end of the study the vitamin group showed improvements in both physical and mental fields in the quality-of-life questionnaires. However, RRMS patients in the control group (without vitamin supplements) also had an increase in the quality-of-life questionnaire for mental health, obscuring any conclusions on the effect of vitamin supplements in MS patients’ mental health. “Results of the present study have shown that homocysteine levels, anemia status, and eventually the quality of life of patients with MS can be significantly improved by administration of 1 mg of vitamin B12 monthly and adding rich-food sources of folic acid on their diet,” the researchers wrote. The team nonetheless emphasizes that "further studies in the field of MS dietary patterns must be conducted."

Multiple sclerosis patients who began treatment with Gilenya and stayed with it continuously showed a more than 50 percent reduction in annual relapse rates, a real-world study following these people for up to three years found. Gilenya, marketed by Novartis, is an oral disease-modifying treatment for relapsing-remitting multiple sclerosis , approved in 2010. It acts by binding and modulating receptors — called sphingosine-1-phosphate receptor — on lymphocytes (adaptive immune cells). By binding to these receptors, Gilenya prevents lymphocytes from leaving the lymph nodes and reaching the brain and spinal cord, and so lower lymphocyte-induced inflammation and damage. Although several clinical trials have reported reduced annualized relapse rates (ARRs) upon treatment with Gilenya, few long-term real-life studies have examined the relapse rate reductions over a long term. A team, led by Novartis researchers and a scientist at Central Texas Neurology Consultants, collected MS patient data from the MarketScan database, a U.S. claims database including medical and pharmacy claims (bills submitted to health insurance providers), between 2009 and 2016. Among 9,312 MS patients in the database with at least one filled Gilenya prescription, 1,599 adults (mean age, 46) met the study's inclusion criteria, including having at least one inpatient or two outpatient claims, and a total of four years of continuous health plan enrollment. Among these 1,599 patients, all used Gilenya for one year (cohort 1), 1,158 (72.4%) took Gilenya continuously up to the start of year two (cohort 2), and 937 (58.6%) used the therapy up to the start of year three (cohort 3). Baseline analysis — measures taken at the study's start — showed that the most common MS-linked symptoms were disorders of the optic nerve and visual pathways (reported in 22-24%), followed by fatigue/malaise (20-21%). Hypertension (20-21%) and depression (15-16%) were the most common physical and mental comorbidities, respectively. The mean annualized relapse rates (AARs) at baseline in these three groups of patients — cohorts 1 to 3 — ranged between 0.48 and 0.51. A consistent reduction in ARRs was seen in all three groups: cohort 1 had a 0.25 ARR at the close of the first year, for a 51% reduction from the baseline rate; cohort 2 a 0.22 ARR at the start of year two, for a  54% lowering in relapse rates from baseline; and cohort 3 had 0.23 ARR at the third year, amounting to a 53% reduction. As expected, when researchers calculated ARRs among patients with continuous Gilenya use over these three years, they found a greater reduction in annual relapse rates. Mean ARRs in continuous-use patients were 0.19 (a 61% reduction) during the first year, 0.18 (a 62% reduction) during the second year, and 0.18 (a 61% reduction) at the start of the third year. “This retrospective claims database study found that patients with MS who received fingolimod [Gilenya] therapy experienced a durable and sustained reduction in relapse rates over a 3-year period,” the researchers wrote, with findings representing “a durable reduction in relapse rates by [more than] 50%.” Reasons that some patients discontinued treatment were not a focus of this study, they added.

A protein called MMP-9 could be a predictive marker of progressive multifocal leukoencephalopathy development in patients with relapsing-remitting multiple sclerosis (RRMS) who are being treated with Tysabri (natalizumab), a study suggests. The study, “Dynamic changes of MMP-9 plasma levels correlate with JCV reactivation and immune activation in natalizumab-treated multiple sclerosis patients,” was published in the journal Nature Scientific Reports. Brain inflammation in multiple sclerosis patients occurs when immune cells breach the blood-brain barrier. This layer of cells protect the brain and its supporting fluids, such as cerebral spinal fluid (CSF), from dangerous agents circulating in blood. How easily immune cells can break through the blood-brain barrier depends on its porousness. For instance, it is known that decreasing the activity of matrix metalloproteinases (MMP) increases the protective layer’s permeability. Matrix metalloproteinases are a family of proteins responsible for the degradation of collagen and other proteins in the extracellular matrix, which provides structural and biochemical support to surrounding cells. One metalloproteinase, called MMP-9, has been extensively studied in multiple sclerosis. MMP-9 levels are elevated in the CSF of multiple sclerosis patients and considered a potential biomarker of disease activity and possible therapeutic target. Tysabri (marketed by Biogen) is one of the most effective treatments for RRMS currently available. It works by blocking the entry of immune cells into the brain. Tysabri is known to decrease MMP-9 levels in the CSF and serum in RRMS patients. However, Tysabri has been associated with an increased risk of developing progressive multifocal leukoencephalopathy (PML). This rare and often fatal viral disease, caused by the John Cunningham virus (JCV), is characterized by progressive damage and/or inflammation at multiple sites in the brain. The reduced migration of immune cells across the blood-brain barrier induced by Tysabri is thought to be the cause of this increased PML risk. Whether MMP-9 is involved in this process has not been studied. To look at this, a team led by researchers from Sapienza University and Aldo Moro University in Italy investigated MMP plasma levels following Tysabri treatment in the context of JCV. The team specifically looked at how levels of MMP-9 were linked to disease-related processes. Samples from 34 RRMS patients being treated with Tysabri (intravenous dose of 300 mg every four weeks) were analyzed. As expected, results showed that MMP-9 plasma levels stabilized within one year of Tysabri treatment (up to 12 Tysabri infusions), although they began to steadily rise afterward (between 12 and 24 infusions). These increased MMP-9 plasma levels were not associated with clinical relapses in RRMS patients. "MMP-9 levels increased in plasma accordingly with [Tysabri] infusion number," the researchers wrote. In comparing JCV-positive and JCV-negative samples, the researchers observed an increase in MMP-9 plasma levels in JCV-positive samples. This result suggested that JCV circulation in peripheral blood could be implicated in the increase of MMP-9 levels. Interestingly, increased MMP-9 plasma levels were found to be correlated with immune cell activation. "Our findings suggest a potential pathogenic role of MMP-9 in the development of progressive multifocal leukoencephalopathy during [Tysabri] treatment, and its possible use as a marker of JCV reactivation,” the researchers wrote. Future studies are nonetheless needed to confirm these findings in larger groups of RRMS patients.

Issues with social cognition can occur in 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, “Social cognition deficits and the role of…

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…