MS relapse

Continuing Tysabri (natalizumab) treatment up to week 28 of pregnancy, and restarting soon after birth, reduces the risk of relapses in women with multiple sclerosis and appears to be safe for the mother and the baby, new research suggests. Doriana Landi, MD, PhD, from Italy’s University of…

Monthly under-the-skin injections of ofatumumab are superior to Aubagio (teriflunomide) to treat relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), leading to over 50% reduction in relapse rates, and more than a 90% reduction in active brain lesions, compared with Aubagio, results from ASCLEPIOS I…

Age at disease onset is tightly linked to clinical outcomes in multiple sclerosis patients, a Swiss study in those on disease-modifying therapies (DMTs) reports. It found a risk of continuous relapses more likely in pediatric MS, and that of disease progression in those with adult-onset MS. Patients at age 40…

Relapses in people with multiple sclerosis (MS) are associated with greater medical and non-medical costs, according to real-world data from two German observational studies. These findings support early treatment with disease-modifying therapies (DMTs) that help to control disease relapses, its researchers said, as a way of possibly reducing such economic…

Using newer disease-modifying therapies (DMTs) as an initial treatment for children and adolescents with multiple sclerosis (MS) or clinically isolated syndrome (CIS) is associated with fewer relapses and brain lesions compared to the use of older and injectable DMTs, according to a real-world study in the U.S.

Oral ozanimod is more effective at reducing the frequency of relapses than Avonex (interferon beta-1a) in patients with relapsing forms of multiple sclerosis (MS), and does so with reasonable safety, results of Phase 3 trial show. These findings were described in the study, “Safety and efficacy of ozanimod…

Using smartphones and smartwatches to monitor disease course via the FLOODLIGHT app leads to high adherence and satisfaction among patients with multiple sclerosis (MS), results from a pilot study show. The research, “Adherence and Satisfaction of Smartphone- and Smartwatch-Based Remote Active Testing and Passive Monitoring in People With Multiple Sclerosis: Nonrandomized Interventional Feasibility Study,” was published in the Journal of Medical Internet Research. Assessing MS progression commonly requires periodic in-clinic visits, and doctors may miss subtle changes occurring between such visits. Smartphones may be a solution for real-time data collection and better patient monitoring outside the clinic. The Roche-sponsored FLOODLIGHT study assessed the feasibility of using smartphones and smartwatches to assess MS symptoms, including hand function, gait and posture, mood, and cognitive impairment. FLOODLIGHT primarily evaluated adherence and feedback to the smartphone- and smartwatch-based assessments, as well as the participants’ satisfaction, as determined by their impact on daily activities. The study included 76 MS patients (ages 20 to 57; 53 were women) and 25 healthy controls, who were recruited at the Multiple Sclerosis Centre of Catalonia in Barcelona, and the University of California, San Francisco. Most patients (91%) had relapsing-remitting MS. The mean time since symptom onset was 11.3 years, and the mean Expanded Disability Status Scale score was 2.4. The test battery included active tests performed daily, weekly, every two weeks, or on demand for 24 weeks, and passive monitoring, which analyzed sensor-based gait and mobility. Participants were instructed to complete the active tests at roughly the same time every day, and to carry the smartphone and smartwatch with them all the time. Adherence was assessed via the proportion of weeks with at least three days of completed testing, and four daily hours of passive monitoring. Satisfaction was determined through a questionnaire. Clinical evaluations were conducted at the study's start, after 12 weeks, and at the study's end. Brain magnetic resonance imaging scans were taken at the enrollment visit and at week 24 (study's end). Most participants finished the study – 92% of MS patients and 64% of the controls. Reasons for discontinuation included the burden of continuous monitoring and lack of availability for the three required in-clinic visits. Over an 18-month period, from November 2016 to April 2018, most participants performed five to seven active tests per week, including the Two-Minute Walk Test (2MWT). Adherence to both active tests and passive monitoring for the 24 weeks was good, and remained stable over time after week six. In the final week, participants had a minimum of four hours of passive monitoring data over an average of four days. Adherence was higher for passive monitoring than the tests. Data showed that 70% of participants completed all active tests, 75% did all active tests except the 2MWT, and 79% had data collected via smartphone- or smartwatch-based passive monitoring. The longer a person's disease duration, the lower was their adherence. In contrast, disease severity was not seen to impact adherence. Overall scores reflecting satisfaction was 73.7 out of 100 at week 24, having remained stable since week 12. Sixty-one patients reported that the test battery had an at least an acceptable impact on daily activities. Thirty-two had no issue with the active tests, while one-third would rather avoid the 2MWT. A majority, 60%, of the MS patients said they would like to continue using the FLOODLIGHT app to better understand their disease and improve its management. “Persons with multiple sclerosis were engaged and satisfied with the FLOODLIGHT test battery,” the scientists wrote. As such, “FLOODLIGHT sensor-based measures may enable continuous assessment of multiple sclerosis disease in clinical trials and real-world settings.” FLOODLIGHT tests are being assessed in long-term studies with larger patient groups in the CONSONANCE Phase 3b trial of Ocrevus (ocrelizumab, by Roche-owned Genentech) in people with progressive MS still enrolling, contact information is here), and in a global study open to all MS patients with a mobile device, called FLOODLIGHT Open.

Monthly injections of ofatumumab led to more clinically meaningful reductions in relapse rates and delayed disability progression than did daily treatment with Aubagio (teriflunomide) tablets in people with relapsing forms of multiple sclerosis (MS), results from two Phase 3 trials showed. Ofatumumab, formerly known as OMB157, is a potent, self-administered…

The relationship between fatigue and patterns of physical activity in people with multiple sclerosis (MS) is not straightforward. New findings show that, among MS patients with similar fatigue levels, there are three different types — or “clusters” — of physical behavior. Clinicians should be aware of these behavioral…

“It could be worse.” That’s a phrase I say to myself when I feel defeated by my multiple sclerosis (MS). When I am exhausted or just feeling “off,” I think I about how much worse my situation could be.   I speak for myself…

Last Thursday was the hottest day ever recorded in U.K. history at 101.6 degrees F. Heat sensitivity is enough to reduce me to the puddle I described last week. But it doesn’t explain the shaking of my body and the extreme pain in my right arm Thursday night. Not…

Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the forum topic “Multiple Sclerosis-related Vertigo: What Can You Do?” from Nov. 23,…

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…

Janssen has announced positive, top-line results from its Phase 3 OPTIMUM study, testing the effectiveness and safety of ponesimod tablets, compared to Sanofi‘s Aubagio (teriflunomide), in adults with relapsing forms of multiple sclerosis (MS). The study met its primary goal — a reduction in the…

Living with multiple sclerosis (MS) is a process of loss — of mobility, brain function, and independence. We can lose relationships and jobs. For most of us, these losses are forever. A woman who commented today on a column I wrote a few weeks ago said that she is…

Scientists identified and “fingerprinted” a group of T-helper cells that are unusually numerous in the blood and central nervous system of people with relapsing-remitting multiple sclerosis (RRMS), and may be the reason behind the neuroinflammation seen in these patients. This T-cell population carries specific markers involved in the transmission…

Gilenya (fingolimod) has been approved in China as a disease-modifying therapy to treat adults and children, ages 10 and older, with relapsing forms of multiple sclerosis (MS). Gilenya, marketed by Novartis, is an oral disease-modifying treatment for relapsing MS. It acts by binding and modulating receptors…

Treating people with relapsing forms of multiple sclerosis (MS) with opicinumab and Avonex (interferon beta-1a) for 72 weeks did not lead to a dose-dependent reduction in disability,  results of a Phase 2 trial show. However, an ongoing study is evaluating opicinumab in a subgroup with better clinical responses.

Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forums. This week’s question is inspired by the forum topic “Do Noise and Crowds Tend to Negatively Affect You More with MS?”…

Mavenclad (cladribine) tablets continue to show sustained efficacy and consistent safety in patients with relapsing forms of multiple sclerosis (MS), post-hoc analyses of a Phase 3 trial extension study show. The findings are set to be presented in several posters during the 5th Congress of the European…

Aubagio (teriflunomide), an approved medicine for relapsing forms of multiple sclerosis (MS), specifically targets highly metabolic and more autoreactive T-cells, analysis of the Phase 3 TERI-DYNAMIC clinical trial data shows. The findings, contrary to expectations, support a selective effect of Aubagio on different T-cell populations. The study “Teriflunomide treatment for multiple sclerosis modulates T cell mitochondrial respiration with affinity-dependent effects” was published in the Science Translational Medicine journal. In MS, immune cells, or lymphocytes known as T-cells, attack and destroy myelin, the fat-rich substance that wraps around nerve fibers (axons). Myelin loss creates lesions that affect nerves of the brain and spinal cord. Previous evidence suggested that T-cells, depending on their active or resting state, rely on specific ways of energy production or metabolism. Aubagio, marketed by Sanofi Genzyme, is a well-known inhibitor of a mitochondrial enzyme called dihydroorotate dehydrogenase (DHODH), that is crucial for the activity of T-cells. However, how Aubagio selectively targets the autoreactive T-cells is poorly understood. To shed light on this matter, an international group of researchers used data from the TERI-DYNAMIC clinical trial that tested Aubagio in patients with relapsing form of MS to better understand how the therapy inhibited the patients' self-immune responses. The Phase 3, open-label TERI-DYNAMIC trial (NCT01863888) included 70 patients from Belgium, Germany, and The Netherlands, aged 18 to 56. Participants received Aubagio as a 14 milligram (mg) once-daily, oral dose, and researchers assessed the changes in immune cells' profile up to 24 weeks. Results showed that, contrary to what was expected, Aubagio was not generally decreasing T-cell levels in treated patients. Instead, it significantly reduced a particular subset of T-cells, called "Th1 helper cells." Moreover, researchers found that the diversity of T-cell receptors — the surface proteins that can recognize a particular antigen (a protein that can elicit an immune response) — making T-cells specific to a certain target was reduced in MS patients after treatment with Aubagio. These findings suggested that some T-cells were particularly susceptible to Aubagio. Using a mouse model for MS, the experimental autoimmune encephalomyelitis (EAE) model, researchers showed that the CD4+ T-cells (helper T-cells) and CD8+ T-cells, those that reacted most strongly against self-antigens, were the most sensitive to DHODH inhibition by Aubagio. Moreover, researchers saw that Aubagio was not affecting the production of pro-inflammatory molecules — called cytokines — at the cell level, but their overall decrease probably was due to the reduction in T-cell numbers. In line with these findings, CD4+ T-cells that produced the cytokine interferon gamma were significantly reduced with Aubagio treatment, whereas CD4+ T-cells that produced interleukin 17A were unchanged. This suggests that Aubagio is able to interfere with specific sub-types of immune cells. When the team compared the metabolic profile of T-cells from healthy subjects with that from patients with relapsing-remitting MS (RRMS) in both remission and in relapse phases, they found that the metabolism of T-cells from the last group was significantly altered, and thus targetable. Altogether, the results suggested that T-cells with a high-affinity to self-antigens are more susceptible to inhibition of the DHODH enzyme by Aubagio. “Therapeutic targeting of metabolic alterations might represent an attractive concept in MS, and might represent an as yet unrecognized key mechanism of teriflunomide-mediated immune modulation in this disease,” the researchers concluded.

FDA and EMA to Review Ozanimod as Possible Oral Therapy for Relapsing MS Another disease-modifying therapy (DMT) is a step closer to gaining approval for use both in the U.S. and in Europe. And that’s good news. The discouraging news, however, is that once again, the approval is being…

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both agreed to review for possible approval ozanimod, Celgene‘s investigational oral therapy for relapsing forms of multiple sclerosis (MS). An FDA decision on the company’s New Drug Application for ozanimod is expected on…

EMD Serono is supporting World MS Day, an initiative created by the Multiple Sclerosis International Federation (MSIF) to promote solidarity and raise awareness about multiple sclerosis (MS) worldwide, by joining efforts to make the disease more “visible.” Known as Merck KGaA…

Vesicles in the blood that contain a protein called fibrinogen important for blood clotting were found to be “sufficient and required” for the occurrence of spontaneous disease relapses in mouse models of multiple sclerosis (MS), a study reports. In mice, these vesicles were associated with immune cell infiltration, inflammation,…

Investigational therapy evobrutinib, also known as M2951, can reduce relapse rates and brain lesions in people with relapsing forms of multiple sclerosis (MS), 48-week data from a Phase 2 clinical trial suggest. Updated results from the trial (NCT02975349) were presented at the recent 2019 annual…

Treatment with Ocrevus (ocrelizumab) decreases the levels of neurofilament light chain (NfL) and immune B-cells in the serum and central nervous system of patients with relapsing multiple sclerosis (MS), according to results from a Phase 3 trial. The research, “Ocrelizumab treatment reduced levels of neurofilament light chain and…

Study Will Explore Benefits of Tai Chi, Meditation on MS Patients’ Balance I’ve tried yoga to help with my balance and flexibility and found it useful. But tai chi scares me a little — it seems too difficult. Maybe, if the results of this study are very positive, I’ll…

High levels of satisfaction with the efficacy and convenience of Aubagio (teriflunomide), an oral treatment for relapsing multiple sclerosis (MS), were reported by patients across the U.S. and 13 other countries, a post-hoc analysis of data from a real-world Phase 4 study found. The study “Teriflunomide real-world evidence: Global…

Editor’s note: This is a guest column by Kristin Hardy, who was diagnosed with primary progressive multiple sclerosis in 2002. Her sister Margaret was diagnosed the same year with relapsing-remitting MS, complicated by trigeminal neuralgia. You are invited to follow Kristin’s blog at www.hackmyms.com. ***…