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.
New 10-year data from the Phase 3 ENDORSE trial confirms the long-term benefits of Biogen’s Tecfidera for patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of this disease. Real-world data from another study also showed Tecfidera to be superior to several other disease-modifying therapies for relapsing MS,…
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…
Treating at-risk relapsing-remitting multiple sclerosis (RRMS) patients is most cost-effective with Mavenclad (cladribine) tablets when compared to Gilenya (fingolimod), Lemtrada (alemtuzumab) or Tysabri (natalizumab), according to a study in Dutch patients. The study, “Cost Effectiveness of Cladribine Tablets for the Treatment of Relapsing-Remitting Multiple Sclerosis in…
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…
Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘s Aubagio (teriflunomide), and Biogen’s Tysabri (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…
Relapsing-remitting multiple sclerosis (RRMS) patients treated with Lemtrada (alemtuzumab) may develop additional (secondary) autoimmune reactions. Anti-CD20 therapies, including rituximab or Ocrevus (ocrelizumab), are a potential treatment for Lemtrada-associated autoimmune complications in patients who fail to respond to other conventional immunotherapies, according to a case report about two women in…
Treatment with Sanofi Genzyme’s Lemtrada (alemtuzumab) for up to two years lowers the levels of serum neurofilament light chain (sNfL), a proposed biomarker of nerve damage, in relapsing-remitting multiple sclerosis (RRMS) patients to levels comparable to those seen in healthy people, data from the CARE-MS I study shows. Lemtrada’s effectiveness…
New research suggests that rising blood pressure might be predictive of intracranial hemorrhage — bleeding in the brain, a serious and sometimes fatal condition — in people with multiple sclerosis (MS) who are receiving treatment with Lemtrada (alemtuzumab). The study, titled “Intracerebral haemorrhage during…
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.
I worked up a little sweat when I was exercising the other day. It was just a tiny bit on my forehead, but it was something I hadn’t felt in many years. I’ve lived with MS since 1980, and before now, I can’t remember the last time I felt sweaty.
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…
Women with MS Have Higher Prevalence of Sexual Dysfunction, Study Reveals I’m surprised that someone felt it necessary to conduct a formal study of this. A glance at multiple sclerosis (MS) groups on social media, although unscientific, would suggest that this is a common problem. And if you’re going…
There’s been a lot of social media chatter following the recent decision by the European Medicines Agency (EMA) to initiate a safety review of Lemtrada (alemtuzumab). The EMA has restricted use of the medication within the European Union (EU) while the review is underway. That’s worrying some people who are…
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…
The European Medicines Agency (EMA) is reviewing safety data for Sanofi Genzyme‘s Lemtrada (alemtuzumab) following new reports of serious treatment side effects. Lemtrada is a humanized monoclonal antibody used to slow disease progression in adult patients with relapsing-remitting multiple sclerosis (RRMS). It works by blocking the activity of…
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…
Stable patients with multiple sclerosis (MS) who transition from Tysabri (natalizumab) treatment to Aubagio (teriflunomide) have a lower relapse risk, a new study shows. The study, “Reducing return of disease activity in patients with relapsing multiple sclerosis transitioned from natalizumab to teriflunomide: 12-month interim results of teriflunomide therapy,”…
Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports The question of whether to start treating multiple sclerosis (MS) with an older, less effective disease-modifying therapy (DMT) and then move to a more effective one — or use a heavy-hitting medication right…
Aubagio (teriflunomide) seems to be superior to Tecfidera (dimethyl fumarate) in slowing whole brain shrinkage in patients with relapsing multiple sclerosis (MS), a new Phase 4 clinical trial shows. However, Aubagio and Tecfidera have similar beneficial effects in achieving other clinical goals and magnetic resonance imaging (MRI) parameters,…
Multiple sclerosis (MS) patients given intensive disease-modifying therapies early in their disease course have more favorable long-term outcomes than those treated with an escalating regimen, real-world data shows. The study, “Clinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis,” was published in the journal …
Are you having trouble paying for MS medications? If so, you’re not alone. People change or lose their insurance, and plans change the medications they cover from year to year. Your neurologist may change your medication without realizing that moving you from an injection to an oral med may…
This probably won’t come as a surprise to you if you’re on Medicare: It’s getting harder to obtain approval for many of the disease-modifying therapies (DMTs) prescribed for people with multiple sclerosis (MS). I see complaints about this all the time on social media. Now, research reported in…
Gilenya is linked to significantly lower annualized relapse rates in relapsing-remitting multiple sclerosis (RRMS) patients compared to Tecfidera or Aubagio, a study suggests. All three therapies showed similar effects on disability outcomes. Oral immunotherapies — including Novartis’ Gilenya, Biogen’s Tecfidera, and Sanofi Genzyme’s Aubagio — 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 therapy’s 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. Patients’ 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. “Choosing 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,” they concluded.
Relapsing-remitting multiple sclerosis (RRMS) patients on Gilenya (fingolimod) have fewer relapses and stay on treatment longer than those taking Tecfidera (dimethyl fumarate) or Aubagio (teriflunomide), according to a new study. The research, “Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis,” was published…
Aubagio (teriflunomide) has become the first once-a-day, oral disease-modifying therapy (DMT) for multiple sclerosis (MS) to be approved for use in India. Sanofi Genzyme’s therapy is indicated for first-line treatment of relapsing MS. It should be taken each day with or without food, and patients in India will have…
A potentially life-threatening case of bleeding in the lungs has been reported and attributed to treatment with Lemtrada (alemtuzumab) by a woman with relapsing-remitting multiple sclerosis. Her medical team found diffuse alveolar hemorrhage in this patient — which resolved in about a week without treatment. The scientists advised that clinicians be alert…
Over the past couple of weeks, two warnings have been issued about side effects of multiple sclerosis (MS) medications. First, the U.S. Food and Drug Administration warned about a slight risk of seriously worsening MS symptoms if someone who is using the disease-modifying therapy (DMT) Gilenya (fingolimod) stops using…
The U.S. Food and Drug Administration (FDA) has issued a safety alert, warning about a rare but life-threatening risk of stroke and artery rupture in patients with relapsing forms of multiple sclerosis (MS) being treated with Lemtrada (alemtuzumab). Since Lemtrada’s approval in 2014 to treat relapsing MS, 13…
Get regular updates to your inbox.