Copaxone

Using Copaxone while breastfeeding safe for infants: Study

Infants breastfed by mothers on Copaxone (glatiramer acetate) for relapsing forms of multiple sclerosis (MS) do not experience more adverse events, hospitalizations, or need more antibiotics for the first 1.5 years than those in the general infant population. That conclusion comes from new analyses of data from COBRA,…

Pregnancy Risks Not Likely to Rise With Early DMT Use, Study Finds

The rates of pregnancy complications are not higher in women with multiple sclerosis (MS) who were using disease-modifying therapies (DMTs) in the earliest stages of pregnancy, a study reported. The study, “Pregnancy outcomes after early fetal exposure to injectable first-line treatments, dimethyl fumarate or natalizumab in…

Marriage, Education, DMT Affect Patients’ Treatment Adherence

Among people with relapsing-remitting multiple sclerosis (RRMS), those who are married and have more formal education are more likely to take treatments as recommended, according to a new study from Iran. The study, “Effects of Disease-Modifying Treatments discontinuation in patients with Relapsing-Remitting Multiple Sclerosis: A 5…

Overall Cost of DMTs Stable 2018–2020, Study Finds

The overall cost of disease-modifying therapies for multiple sclerosis (MS) in the U.S. remained stable from 2018 to 2020, according to pharmacy and medical claims data from Prime Therapeutics’ insured members. This stabilization derived from a balance between a reduction in Copaxone (glatiramer acetate injection) use due…

Trial to Examine if Ocrevus Eases Cognitive Fatigue in RRMS

Researchers at the Kessler Foundation, with support from Genentech, are opening a study into how Ocrevus (ocrelizumab) affects cognitive fatigue — the feeling of complete exhaustion after focused concentration — in people with relapsing-remitting multiple sclerosis (RRMS). Cognitive fatigue is a frequent problem with MS, reported in…

Mavenclad Effectively Lowers Relapse Rates, Study Comparing DMTs Finds

Mavenclad (cladribine) appears to be better at lowering relapse rates during the first two years of disease in relapsing-remitting multiple sclerosis (RRMS) patients than other MS therapies, including interferon, Copaxone (glatiramer acetate) and Tecfidera (dimethyl fumarate), a head-to-head observational study found. Mavenclad, however, was less effective at…

NeuroScientific Biopharmaceuticals’ Lead Candidate, EmtinB, Shows Promise in Preclinical Model of MS

NeuroScientific Biopharmaceuticals (NSB)’s lead candidate EmtinB induces significantly greater myelin regeneration in a cellular model of multiple sclerosis (MS) than the market-leading therapy Copaxone, the company announced. “These results represent a potential breakthrough in the treatment of MS as there are currently no approved therapeutic drugs available to patients that…

Ocrevus Top Choice of US Neurologists for Active SPMS, But Mayzent and Mavenclad Gaining Interest, Report Says

Genentech‘s Ocrevus (ocrelizumab) continues to be the most prescribed medication to reduce inflammatory disease in people with active secondary progressive multiple sclerosis (SPMS) among U.S. neurologists, even though Novartis’ Mayzent (siponimod) and EMD Serono’s Mavenclad (cladribine) were approved in March to treat this same MS…

DMT Choice for Your MS Is Your Decision

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…

Tecfidera May Work to Lower Relapses by Inducing Epigenetic Changes in T-cells, Study Suggests

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."

New Study Supports Hitting MS Fast and Hard

The question of how quickly to start a disease-modifying therapy (DMT) after a multiple sclerosis (MS) diagnosis is one that I frequently see when I browse online. It goes hand in hand with questions about which DMT is best to start with. There are many things to consider when…