Tecfidera

Vitalis is planning to open a pivotal clinical trial into its new formulation of fumarate, called VTS-72, that has shown promise in easing flushing — a common and troublesome side-effect of Tecfidera (dimethyl fumarate), an oral treatment for relapsing-remitting multiple sclerosis (RRMS). The company announced plans to…

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,…

It probably comes as no surprise to you that the costs of some of the most popular MS medications have been soaring. A new study by researchers at the University of Pittsburgh reports that their list prices have more than quadrupled in a decade. And out-of-pocket costs rose even more.

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…

Fewer and less severe gastrointestinal (GI) side effects were evident in relapsing-remitting multiple sclerosis (RRMS) patients taking the investigational oral treatment Vumerity (diroximel fumarate) twice a day compared to those using Tecfidera (dimethyl fumarate), topline data from the EVOLVE-MS-2 trial show. Vumerity is a fumarate compound being developed…

A first healthy volunteer has enrolled in a randomized, double-blind Phase 1 study to compare the gastrointestinal (GI) tolerability and safety of oral Tecfidera to Bafiertam, an oral bioequivalent in treating relapsing forms of multiple sclerosis (MS), Banner Life Sciences…

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…

At the 2019 annual meeting of the American Academy of Neurology (AAN), Multiple Sclerosis News Today sat down with Bernd Kieseier, MD, global head of multiple sclerosis at Biogen, to discuss the company’s portfolio, latest data, and therapeutic development plans in the field of multiple sclerosis (MS). Kieseier said…

Infusible disease-modifying treatment — that is, therapies given intravenously — might have greater benefits for younger people with multiple sclerosis (MS) than oral ones, new research suggests. The research was presented at the ongoing American Academy of Neurology (AAN)’s annual meeting (May 4-10) by Brandi Vollmer,…

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…

About 15 disease-modifying therapies (DMTs) are available to treat MS these days. So, choosing which to use can be daunting. I’ve been treated with four DMTs since I was first prescribed Avonex (interferon beta-1a) back in 1996. Each time I’ve switched treatments, my neurologist has suggested a number of…

Treating multiple sclerosis with Tecfidera induces specific genetic alterations that may reduce the levels of immune T-cells targeting the central nervous system, researchers report. Environmental stimuli may induce epigenetic changes in cells — meaning not alterations in the genes themselves, but changes in gene expression (the process by which information in a gene is synthesized to create a working product, like a protein). Epigenetic changes may induce MS development, as these alterations can cause T-cells to attack the central nervous system. One type of epigenetic change is DNA demethylation, the removal of methyl chemical groups, in which molecules involved in metabolism (such as fumarate) interact with enzymes known as DNA demethylases. This process in key for T-cell activation, function and memory, suggesting that it could be an immunomodulatory target. Fumaric acid esters were shown to be effective in MS clinical trials, leading to the approval of Tecfidera (by Biogen) for people with relapsing-remitting forms of the disease. However, their complete mechanism of action remains unclear. Aiming to address this gap, scientists at the Advanced Science Research Center (ASRC) at The Graduate Center of The City University of New York and the Icahn School of Medicine at Mount Sinai, recruited 98 MS patients, either previously untreated (47 people, mean age of 38.4), treated with Tecfidera (35 people, mean age of 42.3), or treated with glatiramer acetate (16 patients, mean age of 43.4) — marketed as Copaxone by Teva Pharmaceuticals, with generic forms by Sandoz (as Glatopa) and by Mylan. All patients had stable disease for at least three months, but disease duration was shortest in untreated patients — 40.4 months vs. 130 months in those given Tecfidera, and 100 months in patients using glatiramer acetate. Blood samples were collected from each participant to assess epigenetic changes in T-cells expressing the cell surface marker CD4. MS patients typically have an activated form of these cells in their blood and cerebrospinal fluid, the liquid surrounding the brain and spinal cord. Results revealed that, compared to the other two groups, treatment with Tecfidera was associated with a lower percentage of T-cells containing the CD3, CD4, and CD8 markers, as well as lower levels of subsets of T-cells expressing the CCR4 and CCR6 receptors, which are critical to T-cell migration to the gut, brain, and skin. Treatment with glatiramer acetate resulted in significantly milder alterations in T-cell percentages compared to no treatment. Researchers then found that FAEs induce excessive methylation — the addition of methyl groups — in T-cells containing CD4, compared to glatiramer acetate. Specifically, this overmethylation was observed in a micro-RNA — tiny RNA molecules than control gene expression — known as miR-21, key for the differentiation of a subset of T-cells called T helper-17 (Th17) cells and for CCR6 expression in MS mouse models. These Th17 cells are critical in tissue inflammation and destruction, and have been implicated in MS. The epigenetic effects of FAEs were subsequently validated by comparing pre- to post-treatment with Tecfidera in seven patients. In turn, in vitro (lab dish) experiments showed that FAEs act specifically on the activation of naïve T-cells — those able to respond to new pathogens to the immune system — containing the CD4 or the CD8 markers. Of note, patients with MS have shown increased miR-21 levels, particularly during acute relapses. As such, the team hypothesized that its hypermethylation by FAEs could contribute to remission and the prevention of relapses in this patient population. These results "suggest that the metabolic-epigenetic interplay in T-cells could be harnessed for therapeutic purposes," the researchers wrote, and that the immunomodulatory effect of FAEs in MS is due at least in part to the epigenetic regulation of T-cells. The researchers believe that their findings have a broader implication, beyond MS. "Our findings about therapeutically active metabolites have implications for the treatment of not only multiple sclerosis but also other autoimmune diseases, such as psoriasis and inflammatory bowel disease, which involve the same type of T-cells," Achilles Ntranos, the study’s lead author, said in a press release. "Understanding the epigenetic effect of metabolites on the immune system will help us develop several novel strategies for the treatment of autoimmune diseases, which could help patients and physicians achieve better clinical outcomes," Ntranos added. Patrizia Casaccia, the study’s senior author, concluded: "It may one day be possible to target and suppress production of the specific brain-homing T-cells that play a role in the development of MS."

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 …

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…

Banner Life Sciences has received tentative approval from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for Bafiertam (monomethyl fumarate), a novel bioequivalent of Biogen’s Tecfidera (dimethyl fumarate) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Final approval is expected no later than…

Alkermes filed a request for the approval of diroximel fumarate (BIIB098) to treat relapsing forms of multiple sclerosis (MS) with the U.S. Food and Drug Administration (FDA). If approved, diroximel fumarate will be marketed by Biogen in the U.S., likely under the brand name Vumerity. Alkermes and Biogen are working…

Merck KGaA announced that evobrutinib, its oral candidate for relapsing multiple sclerosis (MS), was able to safely and significantly reduce active brain lesions over 24 weeks of treatment, according to results of a Phase 2 study sponsored by the company.

Treatment of relapsing-remitting multiple sclerosis (RRMS) patients with Tecfidera (dimethyl fumarate) is associated with fewer new brain lesions at two years, lower relapse rates, increased time to first relapse, and reduced treatment discontinuation than with Aubagio (teriflunomide), according to a nationwide study from France and a real-world, population-based…

Levels of proposed biomarker neurofilament light chain (NfL) are associated with therapeutic effects of disease-modifying treatments (DMTs) in relapsing-remitting multiple sclerosis (RRMS) patients, according to a real-world study. Study findings also revealed that treatment with either Lemtrada (alemtuzumab, marketed by Sanofi Genzyme), Gilenya (fingolimod, marketed by Novartis), Tecfidera (dimethyl fumarate, marketed…

Many of us have received help to pay for our MS medications. Now there’s a chance that assistance could be threatened. A recent article in the The Wall Street Journal reports that U.S. government prosecutors are looking into whether some pharmaceutical companies’ patient assistance programs are on the wrong…

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…

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…

Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are equally effective as first-line treatments in people with relapsing-remitting multiple sclerosis (RRMS), but Gilenya may be of slightly more benefit to those who switch from a previous injectable therapy, according to a real-world study of patients in Italy. The study, “…

Alkermes announced that it has received a $50 million payment from Biogen after a review of preliminary data related to the gastrointestinal tolerability of BIIB098 (diroximel fumarate), now in pivotal clinical studies as a possible treatment for relapsing forms of multiple sclerosis (MS). BIIB098, formerly known as ALKS 8700…

A one-year analysis of the ongoing Phase 3 EVOLVE-MS-1 trial of ALKS 8700 as a therapy for relapsing remitting multiple sclerosis (RRMS) supports the experimental therapy’s effectiveness, with the treatment significantly reducing the number of MS lesions. Interim results from the trial were presented Tuesday at the…

A compound produced by immune cells is able to treat psoriasis – a skin disorder – in mice, and may be effective against other autoimmune diseases, such as multiple sclerosis, according to a recent study. The study, “Electrophilic properties of itaconate and derivatives regulate the IκBζ–ATF3 inflammatory…

Merck KGaA’s evobrutinib led to significant reductions in relapsing multiple sclerosis patients’ brain and spinal cord lesions, compared with a placebo, a Phase 2b clinical trial showed. Researchers measured the number of lesions at weeks 12, 16, 20 and 24. Evobrutinib, also known as M2951, is an oral inhibitor of…