July 23, 2018 News by Ana Pena PhD Shorter Washout Period Lessens Relapse Risk When Switching from Tysabri to Gilenya in RRMS, Study Finds Shortening the washout period to four weeks when switching from Biogenās Tysabri to Novartisā Gilenya is safe and reduces the chances of experiencing a disease flare in patients with relapsing-remitting multiple sclerosis (RRMS), a small Swiss study found. A four-week washout reduced the risk of having a disease relapse or an increase in disease activity, compared with an eight-week washout period, for two years after switching from Tysabri to Gilenya. Although TysabriĀ effectively slows worsening of MS symptoms and the appearance of disease flares, its use is under a strict risk management plan as it heightens the risk of developing a rare and life-threatening brain infection called progressive multifocal leukoencephalopathy, also known as PML. Some patients may switch to Gilenya, an alternative disease-modifying therapy for RRMS. Gilenya has been associated with a lower risk of PML infection and seen to reduce relapses, disability worsening, and the appearance of new brain lesions on clinical trials. It also is the only therapy approved by the U.S. Food and Drug Administration for children with MS as young as 10. When switching from Tysabri to Gilenya, it is important to consider the washout period, which is the period when the patient is taken off medications. If too long, it may lead to disease reactivation, which can be even stronger than before starting Tysabri. There is little evidence about the optimal length of washout periods, but a Phase 3 trial showed that an eight-week washout between Tysabri and Gilenya was beneficial compared with longer washouts of 12 or 16 weeks. The eight-week washout enabled more RRMS patients to become free from relapses and lowered disease activity. To study if a shorter washout period of four weeks further reduced the risk of MS reactivation, researchers conducted an open-label, observational study at the University Hospital, Basel, Switzerland. The study enrolled 25 RRMS patients who were appointed to switch from Tysabri to Gilenya. Participants were assigned to either a four-week or an eight-week washout period, and were followed for two years after switching to Gilenya. Although patients were older in the four-week washout group, disease activity and disability scoreswere not significantly different between groups at the beginning of the study. Relapses, disability scores, and disease activity on magnetic resonance imaging scans were recorded at baseline and weeks 8, 12, 16, 20 32, 56, and 108. In the first year (week 56) the proportion of patients with disease flare-ups or disease activity on MRI was not significantly different between the two washout groups, affecting 55.6% and 62.5% of the patients who had a four-week and an eight-week washout, respectively. However, at the end of the two-year follow-up (week 108), recurrent event analysis showed that patients who were on the four-week washout group were 77% less likely to experience relapses. The combined risk for relapse or disease activity on MRI also was 58% lower in the four-week group,Ā compared with those who had an eight-week washout. In addition, researchers found that patients who had flares more frequently in the year before discontinuing Tysabri also had a nearly four times higher risk of experiencing relapses in the first year after switching to Gilenya. ThisĀ suggests that the number of relapses before switching from Tysabri can predict disease reactivation once on other disease-modifying therapies. Both washout periods were deemed safe, with no serious adverse side effects or cases of opportunistic infections, including PML, being reported. Researchers emphasized, however, that the findings need to be confirmed in larger studies.
July 11, 2018 News by Vijaya Iyer, PhD Touchscreen-based Cognitive Testing is Effective in MS Care, Study Finds Cognitive impairment is common among patients with multiple sclerosis (MS) and can be assessedĀ through touchscreen cognitive tests in clinical care, a British study reports. The study āInvestigating Domain-Specific Cognitive Impairment Among Patients With Multiple Sclerosis Using Touchscreen Cognitive Testing in Routine Clinical Careā was published in the…
May 3, 2018 News by Alice MelĆ£o, MSc Mavenclad Effective in Treating Highly Active MS, New CLARITY Analysis Shows An additional analysis of data from the CLARITY study confirmed the long-term benefits of treatment with Mavenclad (cladribine tablets) for patients with highly active relapsing forms of multiple sclerosis (MS). The post-hoc analysis, āEfficacy of Cladribine Tablets in high disease activity subgroups of patients…
April 20, 2018 News by Patricia Inacio, PhD #AAN2018 – Switching from Rebif to Ocrevus Improves MS, Extension Study Shows Continuous treatment with Ocrevus (ocrelizumab) or switching from Rebif (interferon beta-1a)Ā to Ocrevus leads to aĀ significant long-term reduction in relapsing multiple sclerosis activity, a two-year extension study shows. Ocrevus’s maker, Genentech,Ā drew the results from anĀ open-label extension of the Phase 3 OPERA trials. Researchers will present the findings at…
April 17, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Siponimod Reduces Disease Activity Biomarker in SPMS Patients Novartis‘ siponimod (BAF312) can reduce blood levels of a biomarker of nerve cell damage in patients with secondary progressive multiple sclerosis (SPMS), a Phase 3 clinical trial shows. Researchers will present the latest results of the ongoing trial at the 2018 annual meeting of the American Academy…
December 13, 2017 News by Patricia Silva, PhD Levels of Nerve Protein in Blood Provide Good Grasp of MS Activity, Study Finds Blood levels of the nerve damage marker neurofilament light provide a reliable picture of multiple sclerosis activity in both the relapsing-remitting and progressive forms of the disease,Ā a Swedish study reports. TheĀ University of GothenburgĀ researchers also discovered a close link between its levels in blood and spinal fluid. This means the…
December 4, 2017 News by Patricia Silva, PhD Blood Test That Helps Predict MS Disease Activity Might Lower Need for MRI Scans, Study Suggests A blood test may someday replace some of the magnetic resonance imaging (MRI) scans taken by people with multiple sclerosis (MS) Ā ā offering an easy, cheap alternative for monitoring disease activity. A study by Norway’s University of BergenĀ found that blood levels of a factor called neurofilament light chain, released…
August 31, 2017 News by Alice MelĆ£o, MSc Tecfidera Shows Promise as Replacement MS Therapy for Tysabri, Study Shows Tecfidera (dimethyl fumarate) can be a suitable replacement therapy whenĀ Tysabri (natalizumab) is discontinued, keeping low levels of disease activity in patients with relapsing-remitting multiple sclerosis (RRMS), according to a report published in theĀ Journal of Neurology, Neurosurgery & Psychiatry. Several studies have demonstrated the effectiveness and…
July 14, 2017 News by Patricia Inacio, PhD High Levels of Pro-Inflammatory Immune Cells in Intestines May Promote MS Activity, Study Reports People with multiple sclerosis have high levels of pro-inflammatory TH17 immune cells in their intestines that correlate with change in the micro-organism mix in their gut and the levels of their disease activity, a study reports. Researchers said the findings suggest that diet, probiotics and therapies that regulate TH17 cells could help treat MS. Probiotics are supplements containing beneficial bacteria. The study, āHigh frequency of intestinal TH17 cells correlates with microbiota alterations and disease activity in multiple sclerosis,ā was published in the journal Science. Research has shown that TH17 cells, also known as T helper 17 cells, play a role in the development of MS. In fact, they were the first harmful immune T-cells to infiltrate the central nervous system, according to studies in animals Where TH17 cells become activated has been unclear, however. Studies in mice suggested it was mainly in the small intestine. Research has also indicated that their activation increases the potential for a person to develop an autoimmune brain disease like multiple sclerosis. An autoimmune disease occurs when the immune system, which defends the body against disease, decides that a person's healthy cells are foreign, and attacks those cells. Researchers decided to see if the findings in mouse models of MS applied to people with the disease. They discovered a link between higher levels of TH17 cells in MS patients' intestines and autoimmune brain problems. They also found a correlation between higher levels of TH17 cells and changes in patients' gut microbiome. The team then identified which bacteria were changing in the gut. Patients with increased levels of TH17 cells and higher disease activity had a higher ratio of Firmicutes to Bacteroidetes bacteria and more Streptococcus strains in their gut, particularly Streptococcus mitis and Streptococcus oralis. Previous studies have shown that these species promote TH17 cell differentiation in humans. Cell differentiation involves a cell transforming from one cell type to another ā usually a more specialized type. This dramatically changes a cell's size, shape, metabolic ā or fuel-burning ā activity, and responsiveness to signals. Some studies have suggested a link between T-cell differentiation and brain autoimmune diseases. āOn the basis of our findings, we speculate that, under certain conditions, or because of still unknown virulence factors, these Streptococcus strains can colonize the small intestine and favor TH17 cell differentiation in the human gut mucosa [linings],ā researchers wrote. In addition to more Streptococcus bacteria, the team detected lower levels of Prevotella bacteria in MS patients with disease activity than in healthy controls or patients with no disease activity. This decrease may also promote TH17 cell differentiation because āPrevotella is capable of producing the anti-inflammatory metabolite propionate that limits intestinal TH17 cell expansion in mice," the researchers wrote. Overall, the team concluded that āour data demonstrate that brain autoimmunity is associated with specific microbiota modifications and excessive TH17 cell expansion in the human intestine.ā The findings suggest that regulating TH17 cell expansion, along with changes in diet aimed at regulating intestinal linings, could be ways to help treat MS.
May 31, 2017 News by Patricia Inacio, PhD #CMSC17 – Lemtrada’s 2 Year Therapy in RRMS Sustains Efficacy for Over 6 Years Without Additional Treatment Taking Lemtrada (alemtuzumab) for two years inhibitedĀ magnetic resonance imaging (MRI) disease activity in patients with relapsing-remitting multiple sclerosis (RRMS) for more than six years, theĀ CARE-MS I clinical trial extension study found. Researchers presented their study,Ā āDurable Efficacy of Alemtuzumab on MRI Disease Activity Over 6 Years in Treatment-Naive RRMS Patients With…
May 30, 2017 News by Patricia Silva, PhD #CMSC17 – Review Suggests Certain MS Patient Groups May Discontinue Disease-Modifying Treatments Older patients with secondary progressive multiple sclerosis (SPMS) as well as older relapsing patients whose MS has been inactive after five years may safely discontinue their treatments, Canadian researchers at Vancouver’sĀ University of British ColumbiaĀ argue. TheirĀ Sanofi Genzyme-sponsoredĀ study, āWhen Should Disease-Modifying Treatments Be Discontinued in Patients with Multiple Sclerosis: An…
March 28, 2017 News by Patricia Silva, PhD FDA Approves Ocrevus as 1st MS Treatment for Both Relapsing and Primary Progressive Forms At long last, and for the first time in medical history, peopleĀ with both relapsing and primary progressive forms of multiple sclerosis have reason to celebrate. The U.S. Food and Drug Administration (FDA) today approved Ocrevus (ocrelizumab)Ā as a disease-modifying therapy for both forms of MS, aĀ chronic autoimmune disease.
March 28, 2017 News by Patricia Silva, PhD Ocrevus’ Journey from Defiant Idea to Game-Changing Treatment Twenty years ago, the idea that B-cell depletion could treat multiple sclerosisĀ would have been greeted with a hearty laughĀ byĀ any well-respected neurologist or MS researcher ā or perhapsĀ a scoff. But times change and research advances. Today, a medicine that gets rid of certain B-cells may beĀ the most powerful drug yetĀ developed against…
February 27, 2017 News by Patricia Inacio, PhD #ACTRIMS2017 – Smoking Significantly Worsens Quality of Life for MS Patients, Study Shows Multiple sclerosis (MS) patients who smokeĀ have a significantly worse quality of life than non-smoking MS patients, concludes a new study. Researchers presented the study,Ā āSmokers with MS have greater decrements in quality of life and disability than non-smokers,ā at the Americas Committee for Treatment and Research in…
February 27, 2017 News by Patricia Inacio, PhD #ACTRIMS2017 – Ocrevus Significantly Decreases Disease Activity in MS Patients, Study Shows Ocrevus (ocrelizumab), an investigational monoclonal antibody, significantly decreases disease activity in patients with multiple sclerosis (MS), and is associated with a higher proportion of patients reaching no evidence of disease activity (NEDA), according to a new analysis. The study,Ā āNEDA analysis by epoch in patients with relapsing multiple…
February 6, 2017 News by Ćzge Ćzkaya, PhD Switching From Gilenya to Lemtrada Seen to Trigger Disease Activity in Some MS Patients Switching from Gilenya (fingolimod) to Lemtrada (alemtuzumab) triggers significant and unexpected disease activity in some patients with multiple sclerosis (MS), according to a study published in the scientific journal Neurology Neuroimmunology and Neuroinflammation.
February 3, 2017 News by Patricia Silva, PhD Clinical Trial Supports Stem Cell Transplants to Treat RMS Patients with High Disease Activity A newly concluded clinical trialĀ gives scientificĀ evidence of the benefits that a stem cell transplantĀ holds forĀ multiple sclerosis (MS) patients who fail to respond toĀ medicationsĀ ā withĀ researchers calling the procedureĀ a reasonable option for thoseĀ with high disease activity. Five years after the treatment ā high-dose immunosuppressive therapy followed byĀ autologous hematopoietic cell transplant ā furtherĀ disease…
January 19, 2017 News by Patricia Silva, PhD Siemens Healthineers and Biogen to Enhance MRI’s Ability to Help MS Patients Siemens Healthineers and BiogenĀ will collaborate to develop new magnetic resonance imaging (MRI) applications that can quantify key markers of multiple sclerosis (MS). āBy bringing together the shared expertise of both Siemens Healthineers and Biogen in imaging and neurology, respectively, we seek to develop new measurement tools that…
December 13, 2016 News by Patricia Silva, PhD Zinbryta Approved in Canada as Once-Monthly Treatment for Relapsing MS Health CanadaĀ has approved Zinbryta (daclizumab)Ā as aĀ treatment for adults with active relapsing-remittingĀ multiple sclerosis (RRMS), BiogenĀ and AbbVieĀ announced. Zinbryta is a long-acting injection therapy, self-administered monthly, for patients who have had an inadequate response to at least two other MS therapies. “ZINBRYTAā¢ is the first once-monthly, self-administered treatment…
October 6, 2016 News by Patricia Inacio, PhD Tysabri May Be More Effective Than Gilenya at Reducing Disease Activity in MS Patients, Study Says An indirect comparison of results from randomized clinical trials in relapsing-remitting multiple sclerosis (RRMS) patients suggests that Tysabri (natalizumab) is more effective than Gilenya (fingolimod) at reducing disease activity. The study, āThe Efficacy of Natalizumab versus Fingolimod for Patients with Relapsing-Remitting Multiple Sclerosis: A Systematic Review, Indirect…
September 23, 2016 News by Patricia Silva, PhD #ECTRIMS2016 – Primary Progressive MS Patients May Soon Have Ocrevus as Treatment Results from the ORATORIO trial, exploring Ocrevus (ocrelizumab) for the treatment of primary progressive forms of multiple sclerosis (MS), showed that the drug stopped disease progression for more than two years in more patients than a placebo. The findings, a highlight at the European Committee for Treatment and Research…
May 17, 2016 News by InĆŖs Martins, PhD Study of Immune System Response to Viral Infection Revives Possibility of Link Between MS and Viruses Researchers investigatingĀ immune B-cell response to the Epstein-Barr virus (EBV) and cytomegalovirus (CMV) found that it may correlate with the amount of brain-specific B-cells in the blood ā a marker of multiple sclerosis (MS) ā and with higher disease activity. The findings were published in the journalĀ Viruses, in…
April 5, 2016 News by Patricia Silva, PhD New Clinical Trial Data on Experimental MS Therapeutic Vaccine, Xemys, Released PJSC Pharmsynthez, a pharmaceutical company based in Russia, recently announced completed follow-up findings and data analysis from a Phase 2a proof-of-concept clinical trial ofĀ its novel therapeutic vaccine Xemys for the treatment of multiple sclerosis (MS). XemysĀ utilizes Xenetic Biosciences patented ImuXen technology. In the open-label, dose-escalating trial, 20 patients…