September 25, 2018 News by Diogo Pinto With Age, Depression Lessens and Quality of Life Improves in MS Patients, Researchers Report A recent study found that elder individuals with multiple sclerosis (MS) experience significantly less severe depressive symptoms and better quality of life than their younger counterparts. The research, āSubjective well-being differs with age in multiple sclerosis: A brief report,ā was published in the journal Rehabilitation Psychology.
September 24, 2018 News by Jose Marques Lopes, PhD CHMP Favors Approving Gilenya to Treat Children and Teenagers with RRMS in Europe The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended thatĀ Gilenya (fingolimod) be approved to treat children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS). If the CHMP opinion is accepted, Gilenya ā marketed by…
September 17, 2018 News by Patricia Inacio, PhD Gilenya More Effective Than Avonex in Lowering Relapse Rates, New Lesions in Children with Relapsing MS, Phase 3 Trial Shows Two years of treatment with oral GilenyaĀ (fingolimod) significantly reduced the rate of relapses when compared toĀ AvonexĀ (interferon beta-1a) intramuscular injections in children and adolescents with relapsing forms of multiple sclerosis (RMS), according to Phase 3 clinical trial results. Additionally, Gilenya (marketed by Novartis) decreased the number of central nervous…
September 10, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: B- and T-cells, Tysabri, Sexual Silence How B-cells Work to Promote T-cell Attacks on Myelin That Lead to MS Detailed in Study I keep a close eye on reports about B-cells and T-cells because they’re the targets of Lemtrada, which is my current disease-modifying therapy. (The DMT Ocrevus targets B-cells alone). So, this…
September 6, 2018 News by Marta Figueiredo, PhD Tysabri Seen to Improve Cognition in RRMS Patients Over 2 Years in Retrospective Study TysabriĀ (natalizumab) was reported in a small retrospective study to significantly improve cognitive abilities in people with relapsing-remitting MS patients (RRMS)Ā over two years of use. The study, āImprovement in Cognitive Function as Measured by NeuroTrax in Patients with Relapsing Multiple Sclerosis Treated with Natalizumab: A 2-Year…
August 30, 2018 News by Marta Figueiredo, PhD Tecfidera, Gilenya Equally Effective, But More MS Patients Stop Tecfidera, Real-World Study Shows TecfideraĀ (dimethyl fumarate) and GilenyaĀ (fingolimod) are equally effective in treating multiple sclerosis (MS),Ā but Tecfidera shows higher rates of discontinuation, according to a real-world study. The study, āDiscontinuation and comparative effectiveness of dimethyl fumarate and fingolimod in 2 centers,ā was published in the journal Neurology Clinical…
August 27, 2018 News by Iqra Mumal, MSc Test to Monitor Tysabri Levels in Relapsing MS Patients, moNATor by Abreos Biosciences, Available in US Abreos BiosciencesĀ announced the U.S. launch ofĀ moNATor, a laboratory-developed test that can help physicians monitor the levels ofĀ Tysabri (natalizumab) in patients with multiple sclerosis (MS). Tysabri (approved for relapsing forms of MS, by Biogen) administered at a dose of 300 mg every four weeks is known to be…
August 23, 2018 News by Stacy Grieve, PhD Case Study Suggests Need for New Treatment Strategy When Switching from Gilenya to Rituximab Discontinuing Gilenya (fingolimod) treatment and starting on rituximab therapy may be more complicated than originally thought. A new report chronicles the medical journey of a man with multiple sclerosis (MS) treated with these drugs, and proposes a new treatment regimen. Both Gilenya (an approved MS therapy marketed by…
August 7, 2018 News by Stacy Grieve, PhD Smoking Increases Relapse Rate in RRMS Patients on Tysabri, Study Suggests Smoking increases the relapse rate in patients with relapsing-remitting multiple sclerosis being treated with Tysabri , an observational study suggests. Multiple sclerosis is a multifactorial disease associated with both genetic and environmental risk factors.Ā Smoking, in particular, has been linked to numerous aspects of MS, including its development and progression. In a previous study, the research team looked at how smoking influences the relapse rate in RRMS patients being treated with interferon beta. From more than 800 patients, they found that smoking one pack per day (about 20 cigarettes) essentially interfered with the positive effect of the IFN-beta treatment and increased the relapse rate by 27%. The researchers then questioned whether the same was true for other treatments. Tysabri, developed by Biogen, is a monoclonal antibody that targets the alpha-4 integrin protein. By interfering with this molecule, the therapy prevents white blood cells from moving into the central nervous system, suppressing the immune reaction that contributes to MS symptoms. In the study, 355 Tysabri-treated RRMS patients from the Danish Multiple Sclerosis Centre were assessed. To gather information on smoking habits and body mass index, the patients filled out a 100-question survey. Data was collected between the start of the treatment and a two-year follow-up visit. Results showed that smoking one pack of cigarettes per day increases the relapse rate by 38% in RRMS patients on Tysabri. This increase in relapse rate takes into account both sex and age at the start of treatment, since ageĀ can affect the relapse rate. For example, an increase in age by one year raises the number of relapses by 2%. The researchers also looked at the relationship between smoking and the presence of two immune-related alleles:Ā HLA-DRB1*15:01 andĀ HLA-A*02:01. Previous studies showed that HLADRB1*15:01Ā is associated with an increased risk ofĀ developing MS, whileĀ HLA-A*02:01 is linked to a decreasedĀ risk. Although previous studies reported a link between smoking and these two alleles in MS patients, the current study did not find an association between smoking and carrying either of these alleles. Based on the results, the researchers concludedĀ that smoking significantly increases the relapse rate in RRMS patients receiving Tysabri. According to the team, the results "add important informationĀ that hopefully will sharpen the focus on the overallĀ harmful effects of smoking in MS patients."
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 20, 2018 News by Iqra Mumal, MSc Tysabri Treatment Lessens Sexual Dysfunction in MS Patients, Study Finds Treatment with Tysabri (natalizumab)Ā can help lessen sexual dysfunction in patients with multiple sclerosis (MS), a new study shows. The study, āPatient perceived changes in sexual dysfunction after initiation of natalizumab for multiple sclerosis,ā was published in the Multiple Sclerosis Journal ā Experimental, Translational and Clinical. MS is…
June 25, 2018 News by Patricia Inacio, PhD Online Aid for MS Patients with Cognitive Difficulties Now Part of MyMSTeam MyHealthTeams together with Biogen launched a new online tool center, called MS and Cognition Resource Center, to educate multiple sclerosis (MS) patients on brain health, and to help them better understand how MS impacts the brain and how they might manage the cognitive challenges the disease brings.
June 15, 2018 Columns by Ed Tobias Getting Help Paying for Your MRIs It’s not unusual for someone with MS to have an annual MRI exam. Sometimes it’s even semiannual. And it’s not cheap. According to the website Healthcare Bluebook, an MRI of the brain, with and without contrast, can cost you anywhere from $826 to $4,780, depending on where youĀ live…
June 13, 2018 News by Vijaya Iyer, PhD Effectiveness of Gilenya and Tecfidera Compared in Real-World Study in Italy Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are equally effective as first-line treatments in people with relapsing-remittingĀ 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, “…
June 11, 2018 News by Patricia Silva, PhD BIIB098 Showing Ability in Studies To Be Easier on GI Tract Than Tecfidera, Earning Alkermes $50M from Biogen Alkermes announced that it has received a $50 million payment from Biogen after a review of preliminary data related to theĀ gastrointestinal tolerability ofĀ 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…
June 6, 2018 News by Larry Luxner Canada Trails US in Patient Access to Rare Disease Therapies, CORD President Says Canadaās healthcare system is excellent for people with common ailments like diabetes or high blood pressure, but itās ābasically failing the nearly three million Canadians with rare diseases.ā So says Durhane Wong-Rieger, president and CEO of the Canadian Organization for Rare DisordersĀ (CORD), a Toronto-based network representing 102 patient advocacy…
May 25, 2018 Columns by Ed Tobias Two MS Medications Appear on FDA’s Shame List Two multiple sclerosis medications that are both popular and expensive are on a new list that U.S. regulators hope will increase price competition. The medications are Ampyra (dalfampridine), made by Acorda, and TecfideraĀ (dimethyl fumarate), by Biogen. They’re included on a list of more than 50…
May 23, 2018 News by Diogo Pinto European EMA Confirms Severe Risks Associated with MS Medicine Zinbryta A review of data concerning the multiple sclerosis (MS) medicine Zinbryta (daclizumab) confirmed its association with the risk of developing severe and potentially fatal immune reactions in the brain, liver and other organs, according to the European Medicines Agency’s (EMA)ās Pharmacovigilance Risk Assessment Committee (PRAC). Zinbryta was authorized…
May 21, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: PML Treatment, Gilenya for Kids, Rituximab, and an MS trial that is Enrolling Complications from Gilenya Treatment Managed Successfully, Case Report Says This wasn’t a minor complication. It was a version of PML, a brain disease that can be fatal. PML is also a known side effect of Tysabri, so the report of a successful treatment should be important to…
May 18, 2018 News by Iqra Mumal, MSc Rituximab Seen as Effective and Generally Safe RRMS and PMS Treatment in Study Rituximab is generally safe and effective in treating multiple sclerosis ā with comparable effectiveness to Tysabri (natalizumab) in people with relapsing-remitting forms of the disease, a Swiss study reports. But patients using this therapy can develop recurrent infections, its researchers noted, and doctors should be vigilant. The observational study, ā…
May 16, 2018 News by Patricia Silva, PhD 4 Relapsing MS Treatments Added to UK Health Service After Cuts to Prices Agreed After an agreement to lower their prices, four treatments for relapsing multiple sclerosis āĀ Biogenās AvonexĀ and Merck KGaA‘sĀ Rebif (both interferon beta-1a), Novartisā ExtaviaĀ (interferon beta 1b), and Tevaās Copaxone (glatiramer acetate) ā were recommended as cost-effective and long-term therapy options within the National Health Service…
May 14, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: An MS Program for Young Adults, Rituximab Report, Repairing Myelin, and Reducing Inflammation Organizations Join Forces to Launch New Adventure Program for Young MS Patients It seems we too often ignore the needs of younger people who have MS. (I’ve written a couple of columns about this.) This program isn’t a medical approach, but it may serve some other…
April 27, 2018 News by Patricia Inacio, PhD #AAN2018 – Extending Time Between Tysabri Doses Linked to Lower PML Risk, Analysis Suggests Extending the time between standard doses ofĀ TysabriĀ (natalizumab)Ā from four weeks to up to 12 weeks is linked to a significant decrease in the risk of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients infected with what’s known as the JC virus, according to a recent analysis of data from…
April 19, 2018 News by Patricia Inacio, PhD #AAN2018 – Biogen Data Covers Work into an MS Blood Biomarker, Cognition and Life Quality Research that points to aĀ potential blood biomarker ofĀ multiple sclerosis (MS) severity, relates cognitive difficulties to patients’ employment and other measures of socioeconomic status, and one-year results of an ongoing clinical trial are among data presentations planned byĀ BiogenĀ for theĀ annual meeting of the American Academy of Neurology (AAN). This year’s…
April 18, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Levels of Protein Derived from Brain Cell Damage Can Mirror Severity of MS, Study Finds Levels of a protein stemming from brain cell damage can mirror the severity and symptoms of multiple sclerosis, an analysis of combined data from three trials showed. Researchers will present this and related findingsĀ at the annual meeting of the American Academy of NeurologyĀ in Los Angeles, April 21-27. The…
April 10, 2018 News by Patricia Silva, PhD Dartmouth-Hitchcock Starts Three-year Study of Ways to Improve Quality of MS Care TheĀ Dartmouth-HitchcockĀ health system is starting a three-year nationwide study of the quality of care that multiple sclerosis patients receive. It will focus on geographic differences in care and quality improvement. The project’s name is theĀ Multiple Sclerosis Continuous Quality Improvement Collaborative study. Its goal is to improve care by sharing…
March 12, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: Zinbryta, Fish Oil, MS Associate Certification, Blood-brain Barrier Biogen and AbbVie Voluntarily Withdraw Marketing Authorizations for MS Therapy Zinbryta You may have heard about this already, so forgive me if it’s not new to you, but it’s important information. A dozen cases ofĀ encephalitis or meningoencephalitis have been reported in patients using Zinbryta, and…
March 6, 2018 News by Jose Marques Lopes, PhD Biogen and AbbVie Voluntarily Withdraw Marketing Authorizations for MS Therapy Zinbryta BiogenĀ and AbbVieĀ have voluntarily withdrawn global marketing authorizations for theirĀ relapsing multiple sclerosisĀ therapyĀ Zinbryta (daclizumab) because of serious side effects that include brain inflammation. The Europe Medicine Agency, which oversees medications across the European Union, also released a statement recommending a “immediate suspension” of Zinbryta’s use by patients and…
February 27, 2018 Columns by Ed Tobias What’s Hot and What’s Not Among MS Therapies? The newest kids on the MS block, disease-modifying therapies (DMT) such as Genentech’s Ocrevus (ocrelizumab) and Sanofi Genzyme’s Lemtrada (alemtuzumab), are attracting a lot of interest these days. But, some DMTs that have been around for more than two decades are still being prescribed by a lot of neurologists.
February 19, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: Stem Cell Trial, Medical Marijuana, Myelin Repair, Tysabri Study Stem Cell Treatment Benefits Three-fourths of MS Patients in Phase 1 Trial This is encouraging news for MS patients hoping to see some action in the stem cell area. A Phase 1Ā mesenchymal stem cell trial is reporting positive results, and a Phase 2 trial is underway in…