Aubagio

Two global Phase 3 clinical trials, both comparing Sanofi Genzyme’s investigational tolebrutinib with its approved therapy Aubagio, are enrolling a total of 1,800 people with relapsing multiple sclerosis (MS), the company said. All patients in both studies — dubbed GEMINI 1 and GEMINI 2 — will…

Ublituximab, an investigational anti-CD20 antibody, outperformed Aubagio (teriflunomide) in lowering the frequency of relapses among people with active, relapsing forms of multiple sclerosis (MS), according to top-line data from the Phase 3 ULTIMATE trials. Full results, including data on safety and secondary goals, are expected to be presented…

Review Study Examines Factors That Affect MS Patients’ Quality of Life What affects the qualify of your life as someone who lives with MS? Fatigue is at the top of my list, followed by difficulty walking. Now, COVID-19 plus gray, winter weather have added a bit of depression. So,…

Studied for the first time, Aubagio (teriflunomide) slowed the loss of cortical grey matter and whole-brain volume in people with clinically isolated syndrome (CIS) during two years of therapy, a study found. The treatment was especially effective in those without brain lesions before treatment.

Mayzent Approved for Active SPMS Patients in England and Wales This is great news for people with MS in England and Wales. Mayzent (siponimod) is a needed weapon in the MS battle. It is approved for use in active cases of secondary progressive MS (SPMS), while most other disease-modifying…

Prior treatment with disease-modifying therapies (DMTs) does not affect the long-term benefits of Aubagio (teriflunomide) in treating relapsing forms of multiple sclerosis (MS), according to a review study. The study, “Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis,”…

Continuous treatment with Aubagio (teriflunomide) can safely lower the risk of relapses and disability progression in children with relapsing forms of multiple sclerosis (MS), according to interim data from the open-label extension of a Phase 3 trial. These findings were detailed at MSVirtual2020 by Tanuja Chitnis, MD,…

Janssen Pharmaceuticals’ investigational oral therapy ponesimod is superior to Sanofi’s Aubagio (teriflunomide) in delaying disability progression in adults with relapsing multiple sclerosis (MS), according to exploratory analyses of OPTIMUM clinical trial data. These and other findings from Janssen’s MS research program, including on the health…

Ofatumumab Seen as Superior to Aubagio at Lowering Relapse Rates in Phase 3 Trials Ofatumumab is a cancer medication that’s awaiting approval by the U.S. Food and Drug Administration and the European Medicines Agency to treat MS patients. It’s delivered by injection once a month and aims to reduce…

Aubagio (teriflunomide), taken as a 14 mg tablet once a day, shows long-term safety and efficacy in patients with relapsing forms of multiple sclerosis (MS), according to results of the Phase 3 TOWER extension study. Treatment was generally well tolerated by the 751 patients using Aubagio for a median…

Novartis‘ ofatumumab outperformed Aubagio (teriflunomide) at lowering the frequency of relapses and preventing disability progression among people with relapsing forms of multiple sclerosis (MS), a study based on clinical trial data reports. The study, “Ofatumumab versus Teriflunomide in Multiple Sclerosis,” was published in…

Five people with multiple sclerosis (MS) who tested positive for COVID-19 while being treated with Aubagio (teriflunomide)  all developed a mild infection, had good outcomes, and experienced no disease relapses, a case study reported. These findings suggest that use of Aubagio, a disease-modifying therapy that acts on the immune system,…

Ponesimod may soon be a new oral therapy for people with relapsing multiple sclerosis (MS) in Europe, and a filing for its approval in the U.S. is likely within weeks. Janssen Pharmaceuticals, its developer, submitted an application to the European Medicines Agency (EMA) in early March, a first ponesimod filing…

Actelion‘s ponesimod, an investigational oral treatment, is superior to Sanofi‘s Aubagio (teriflunomide) in lessening the frequency of relapses and easing fatigue symptoms in adults with active, relapsing multiple sclerosis (MS), results of the OPTIMUM trial show. These data will lay the ground for submissions…

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…

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…

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…

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.

Aubagio taken as 14 milligram (mg) tablet once daily significantly reduces the risk of relapse in people with relapsing multiple sclerosis (MS) over time irrespective of their prior treatment history, a pooled analysis of Phase 2 and Phase 3 trial results show. The findings were presented at the 2019…

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…

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…

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…

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,…

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…

The U.S. Food and Drug Administration (FDA) has approved a generic version of  Aubagio (teriflunomide) tablets at the 7 mg and 14 mg doses marketed by Sanofi, according to the generic’s manufacturer, Glenmark Pharmaceuticals. The FDA’s decision to approve the company’s application for teriflunomide tablets at two…