The U.S. Food and Drug Administration (FDA) has approved Novartis’ Mayzent (siponimod) oral tablets for adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive disease (SPMS). Mayzent was designed to inhibit the activity of…

Treatment with ublituximab continues to be safe and well-tolerated by patients with relapsing forms of multiple sclerosis, according to an extension study of a Phase 2 trial. According to a press release, Edward Fox, MD, PhD, from Central Texas Neurology Consultants, will give the presentation on May 7 at poster session P3: MS Clinical Trials and Therapeutic Research. Ublituximab is an investigational monoclonal antibody being developed by TG Therapeutics to target the immune B-cell marker protein CD20. This leads to the depletion of B-cells from the blood and central nervous system — B-cells are activated during MS relapses. According to the company, ublituximab may be superior to current anti-CD20 treatments in MS, enabling both lower doses and shorter infusion times. Final results of the main TG-Therapeutics-sponsored Phase 2 trial were recently presented at the 4th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held in Dallas, Texas. Data showed that 93% of the 48 patients enrolled (mean age 40 years) were relapse-free after a 48-week treatment with ublituximab. The annualized relapse rate — the number of relapses per year — was 0.07. In addition, median B-cell depletion was more than 99% throughout 48 weeks. Moreover, 87% of participants showed no evidence of clinical disease. Magnetic resonance imaging showed a complete elimination of T1 lesions at 24 and 48 weeks 24 in all 46 patients analyzed. Mean T2 lesion volume decreased by 10.6% at 48 weeks, compared with the beginning of the study. T1 lesions refer to areas of active inflammation and disease activity, while T2 lesions are a measure of the total amount of lesions, both old and new. Ublituximab was found to be well-tolerated, and did not induce an severe treatment-related adverse events. The most frequent adverse events were infusion-related reactions. No patient had to discontinue treatment due to an ublituximab-related side effect. At the upcoming AAN meeting, Fox will present data on both this Phase 2 trial and its open-label extension, in which 37 patients from the primary study continued receiving one-hour infusions of 450 mg of ublituximab every 24 weeks for an additional 96 weeks. Safety was monitored throughout the study, and disability assessments using the Expanded Disability Status Scale were conducted every 48 weeks. As of October 2018, nearly 30% of participants had completed 48 weeks of treatment in the extension study. Results showed that ublituximab continues to be well-tolerated, with no discontinuations due to adverse events. “The Phase 2 OLE supports that one-hour infusions of [ublituximab] continue to be safe and well tolerated,” the researchers wrote. Of note, five of the eight study authors are affiliated with TG Therapeutics. The team expects additional patient follow-up data from the study to be available by the time of the AAN presentation. According to the scientists, the results support the ongoing Phase 3 ULTIMATE program, which includes the ULTIMATE 1 and ULTIMATE 2 trials. These studies are comparing the efficacy and safety of 450 mg of ublituximab with Aubagio over 96 weeks of treatment in relapsing MS patients. Both trials are led by Lawrence Steinman, MD, at Stanford University. TG Therapeutics expects to have results from these trials as early as mid-2020.

Drinking about 290 calories of sugar-sweetened beverages — the equivalent of about two cans of non-diet soda — per day may be associated with a higher level of disability in patients with multiple sclerosis (MS), compared to those who seldom consume such beverages, according to a preliminary study. The…

MSCopilot, a software device designed for the self-assessment of multiple sclerosis (MS), distinguishes between patients and healthy controls, and potentially could be used in clinical practice for the monitoring of MS disability progression and patients’ response to treatment. Matthieu Lamy, from Ad Scientiam, the…

Full results of a Phase 2 clinical trial testing TG Therapeutics’ lead candidate ublituximab (TG-1101) for relapsing multiple sclerosis (MS) showed that treatment for 48 weeks resulted in a marked reduction of brain and spinal cord lesions, an almost complete depletion of relapse-associated immune B-cells, and significantly halted disability…

As the protective molecular caps of our genetic information — called telomeres — become shorter in certain immune cells, the extent of multiple sclerosis (MS) disability progression increases, regardless of age, researchers at the University of California, San Francisco (UCSF) reported. The findings were presented at the annual…

Low income and education levels are linked to a higher risk of physical disability and disease progression in patients with multiple sclerosis (MS), study says. The study with that finding, “Socioeconomic status and disability progression in multiple sclerosis,” was published in the journal Neurology. “This study is the…

Multiple sclerosis (MS) patients eat a more limited diet, with a lower average of 31 nutrients, including zinc, thiamin, and iron, when compared with healthy controls, a study shows. Blood tests also showed that MS patients had significantly lower iron levels, a different fatty acid composition in their red blood…

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,…

Patients with relapsing-remitting multiple sclerosis, particularly those with multiple conditions who are more severely disabled, are more likely to be using several medications at the same time, a study shows. These findings highlight the need for physicians to be aware of what medications their patients are taking to avoid…

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.

Treatment with Ocrevus (ocrelizumab) has superior or comparable effectiveness and a similar safety profile to other available disease-modifying treatments (DMTs) for treating relapsing multiple sclerosis (MS), according to a new review study. The research, “Systematic review and network meta-analysis comparing ocrelizumab with other treatments for…

Fatigue is more prevalent among patients with progressive multiple sclerosis (MS), according to a study that surveyed patients on fatigue and factors related to it. In addition, increased fatigue severity correlated with greater physical, cognitive, and psychological impairment, although the strength of this link was largely the same…

Autologous hematopoietic stem cell transplant is better than disease-modifying therapies (DMT) at reducing the risk of disease progression in patients with relapsing-remitting multiple sclerosis (RRMS), results from the MIST clinical trial show. The study “Effect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression…

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…

Dozens of films have focused on those with diseases or disabilities — and there’s no shortage of Hollywood productions about love and sex. But only a handful have ever really tried to combine these two themes. “Take a Look at This Heart” does the job with tenderness and finesse.

Treatment with autologous hematopoietic stem cell transplant (aHSCT) led to a sustained decrease in disability and almost no clinical relapses in patients with relapsing-remitting multiple sclerosis (RRMS) who had failed to respond to prior immunosuppressive therapies, an Australian Phase 2 trial shows. Trial findings were published in the study, “Prospective phase…

Inactivation of S1PR2, a cell surface protein, helps improve clinical disability and reduce demyelination in a mouse model of experimental autoimmune encephalitis (EAE), a condition similar to multiple sclerosis (MS) in humans, a study shows. This finding suggests that therapies blocking S1PR2 could have the potential to treat MS. The…

Tysabri (natalizumab) was found to be superior to interferon beta (IFN-β) in a small, 12-month study with relapsing-remitting multiple sclerosis (RRMS) patients, significantly decreasing their disability levels, its researchers report. A vast majority — 90 percent — of Tysabri-treated patients experienced no relapses during the study period,…

High levels of certain lipids, or fat, in the blood are linked to increased disability scores and high levels of pro-inflammatory markers in relapsing-remitting multiple sclerosis (RRMS) patients, a small study reports. The study, “Lipoprotein markers associated with disability from multiple sclerosis,” was published in the journal Scientific…

Atara Biotherapeutics’ investigational ATA190, a cell therapy that wipes out immune B-cells infected with the Epstein-Barr virus (EBV), led to neurological improvements and reduced symptoms in patients with primary and secondary progressive multiple sclerosis (MS), a Phase 1 trial shows. The trial results were published in the Journal…

Treatment with autologous hematopoietic stem cell transplant (aHSCT) led to a safe and rapid lessening of disability and no clinical relapses in patients with aggressive multiple sclerosis (MS), according to a new study. The research, “The use of autologous hematopoietic stem cell transplantation as a…

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…

Up to half of women with multiple sclerosis (MS) who stop treatment with Gilenya (fingolimod) when planning to become pregnant will experience a relapse during pregnancy, according to a new study. The findings also revealed relapses over the first six months after giving birth in a quarter of…

Relapsing-remitting multiple sclerosis (RRMS) patients with serum neurofilament light chain (sNfL) levels higher than a proposed threshold have a higher risk of disease activity, and worsened disability, lesions and brain shrinkage in the long term, according to a new study. The research, “Serum neurofilament light (NfL)…

Lesions in the infratentorial region of the brain at the onset of clinically isolated syndrome (CIS) and lesions in white matter one year after CIS onset are associated with worse disability 30 years later, a study reports. The study, “Early MRI predictors of long-term multiple sclerosis outcomes:…

Infections and complications from severe disability are the greatest contributors to mortality among multiple sclerosis (MS) patients, according to a population-based study in British Columbia, Canada, which also found that that MS is a more common underlying cause of death among younger patients. The study, “Causes that…

Multiple sclerosis (MS) patients with depression or bipolar disorder may be at higher risk of becoming incapacitated and seeing their disability worsen faster, according to a Swedish study. A depressive state may increase the central nervous system response’s to inflammation and accelerate the…

Patients with relapsing-remitting multiple sclerosis (RRMS) who switch to Tysabri (natalizumab) after relapses on first-line treatment with other medications show greater relapse reduction and less disability progression than those switching to Gilenya (fingolimod), according to a real-world study. The research, “Comparative effectiveness of switching…

Treatment with disease-modifying therapies (DMTs) may benefit patients with secondary progressive multiple sclerosis (SPMS) who are actively experiencing relapses, as they can slow the disability’s worsening, a new analysis of an MS patient registry shows. Patients…