January 30, 2019 News by Jonathan Grinstein Canadian RRMS Patients Less Likely to Discontinue Treatment with Oral Gilenya, Compared to Injectable or Infusible Therapies Multiple sclerosisĀ (MS) patients in Canada are more likely to comply with their treatment plan and less likely to discontinue the use of the oral disease-modifying treatment Gilenya (fingolimod), compared to injectable or infusible treatment options, new research shows. The research article with that finding, āA…
January 29, 2019 News by Patricia Inacio, PhD Gilenya Better at Lowering Relapse Rate than Tecfidera or Aubagio, Study Suggests Gilenya is linked to significantly lower annualized relapse rates in relapsing-remitting multiple sclerosis (RRMS) patients compared to Tecfidera orĀ Aubagio, a study suggests. All three therapies showed similar effects on disability outcomes. Oral immunotherapies ā including Novartisā Gilenya, Biogenās Tecfidera, and Sanofi Genzymeās Aubagio ā 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 therapyās 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. Patientsā 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. āChoosing 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,ā they concluded.
January 18, 2019 News by Patricia Inacio, PhD Blood Stem Cell Transplant Better than DMTs at Reducing Risk of Disease Progression in RRMS 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 āEffect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression…
January 17, 2019 News by Jose Marques Lopes, PhD Fewer RRMS Patients Relapse, Discontinue Treatment with Gilenya, Study Finds Relapsing-remitting multiple sclerosis (RRMS) patients on Gilenya (fingolimod) have fewer relapses and stay on treatment longer than those takingĀ Tecfidera (dimethyl fumarate) or Aubagio (teriflunomide), according to a new study. The research, āComparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis,ā was published…
January 11, 2019 News by Alice MelĆ£o, MSc Mavenclad Approved for Reimbursement as RRMS Treatment in Australia Australia was one of the first countries to approve the use of Mavenclad (cladribine tablets, 10 mg) to treat patients with highly active relapsing-remitting multiple sclerosis (RRMS).Ā Now, the countryās government has taken another step to ensure this 20-day course treatment is available to the largest number possible of people affected by the disease. Australiaās Prime Minister, Hon. Scott Morrison MP, announced that Merck KGaAās therapy was included on the Pharmaceutical Benefits Scheme (PBS) listing effective Jan. 1. This will make Mavenclad affordable for about 6,200 patients each year who are already accessing PBS-subsidized medicines for MS. (Of note, Merck KGaA is known as EMD Serono in the U.S. and Canada.) This was made possible by the joint effort of MS Australia, MS Research Australia, clinicians and members of the MS community who, after successive submissions, achieved a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) to list Mavenclad on PBS as a treatment for RRMS. Australia's government will cover almost all costs of Mavenclad, which will mean that patients will have to pay only $40.30 per prescription, or $6.50 for concessional patients. āThanks to our strong economic management, weāve ensured that every new, essential medicine recommended for listing by the Pharmaceutical Benefits Advisory Committee receives government subsidy to make it affordable for all Australians,ā the Prime Minister said in a press release. Mavenclad was developed to target immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. To be taken for a maximum of 20 days over two years, the oral drug has shown it helps MS patients remain relapse-free for up to four years, while supporting the āresetā of the immune system. Australia's regulatory agency decided to approve Mavenclad based on the findings of a number of clinical trials, including the Phase 3 CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537), and ORACLE-MS (NCT00725985) studies, as well as the Phase 2 trial ONWARD study (NCT00436826), and the long-term PREMIERE (NCT01013350) trials. These clinical studies involved more than 2,700 RRMS patients, some of whom were followed for more than 10 years. Overall, the trials showed that Mavenclad significantly reducedĀ relapse rates, disability progression, and brain atrophy. Doctors recommend the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments.
January 4, 2019 News by Alberto Molano, PhD Bafiertam, a Bioequivalent of Tecfidera, Receives Tentative OK from FDA for RRMS Banner Life SciencesĀ 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 Biogenās Tecfidera (dimethyl fumarate) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Final approval is expected no later than…
December 21, 2018 News by Patricia Inacio, PhD Stem Cell Transplant Lessens Disability and Relapses in RRMS Patients, Phase 2 Trial Shows Treatment withĀ autologous hematopoietic stem cell transplantĀ (aHSCT) led to a sustained decrease in disability and almost no clinical relapses in patients withĀ relapsing-remitting multiple sclerosisĀ (RRMS)Ā who had failed to respond to prior immunosuppressive therapies, an Australian Phase 2 trial shows. Trial findings were published in the study, āProspective phase…
December 18, 2018 News by Alice MelĆ£o, MSc FDA Asked to Approve Diroximel Fumarate as Oral Treatment for Relapsing MS AlkermesĀ filed a request for the approval of diroximel fumarate (BIIB098) to treatĀ relapsing forms of multiple sclerosis (MS) with the U.S. Food and Drug Administration (FDA). If approved, diroximel fumarate will be marketed by BiogenĀ in the U.S., likely under the brand name Vumerity. Alkermes and Biogen are working…
December 12, 2018 News by Alice MelĆ£o, MSc Ocrevus Now Available Through NHS Scotland to Treat RRMS Ocrevus (ocrelizumab, by Genentech) is now available through the National Health System (NHS) of Scotland to treat patients with relapsing-remitting multiple sclerosis (RRMS). The decision by the Scottish Medicines Consortium (SMC) to approve Ocrevus’ inclusion for this patient group follows theĀ recommendationĀ made earlier by the U.K.ās…
December 5, 2018 News by Patricia Inacio, PhD Aspirin Suppresses MS Symptoms by Preventing Loss of Regulatory T-cells, Mouse Study Shows Aspirin, administered orally at low doses, was sufficient to suppress multiple sclerosis (MS) symptoms in a mouse model of relapsing-remitting MS (RRMS) and chronic MS, a study reports. The clinical benefits of aspirin were linked to an increase in the number of regulatory T-cells, those responsible for shutting…
November 30, 2018 News by Alice MelĆ£o, MSc Gilenya Now Approved in Europe to Treat Children, Adolescents with RRMS Gilenya (fingolimod) was approved by the European Commission as a treatment for children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS), Novartis announced. The therapy is already approved in Europe to treat RRMS patients 18 and older. With this newest decision, Gilenya has become…
November 28, 2018 News by Patricia Inacio, PhD High Lipid Levels Associated with Increased Disability, Inflammation in RRMS Patients, Study Shows High levels of certain lipids, or fat, in the blood are linked to increased disability scores and high levels of pro-inflammatory markers inĀ relapsing-remitting multiple sclerosis (RRMS) patients, a small study reports. The study, āLipoprotein markers associated with disability from multiple sclerosis,ā was published in the journal Scientific…
November 26, 2018 News by Jose Marques Lopes, PhD Gilenya-induced Changes in Heart Rate May Predict Degree of Drop in Lymphocytes, Study Reports Assessing changes in a person’s heart rate can help to predict the degree to which lymphocyte numbers will decrease in relapsing-remitting multiple sclerosis (RRMS) patients usingĀ Gilenya (fingolimod), according to a small study. The research, āFingolimod-induced decrease in heart rate may predict subsequent decreasing degree of…
November 20, 2018 News by Patricia Inacio, PhD RRMS Diagnosed Most Often in Younger Women and PPMS in Older Men, European Study Reports Women withĀ multiple sclerosis are being diagnosed at younger ages and in greater numbers than men, except for those with primary progressive disease (PPMS), where men 50 or older tend to predominate, a European review study that looked at trends over several decades reports. The study āAgeādependent variation of female…
November 9, 2018 News by Alberto Molano, PhD Study Highlights Need for Better Engagement Between MS Patients and Healthcare Providers Multiple sclerosis (MS) relapses can be challenging for some patients, and better engagement is needed between patients and their healthcare providers, a study focused on patient experiences has found. The study, titled āRelapse prevalence, symptoms, and health care engagement: patient insights from the Multiple Sclerosis in America 2017 survey,ā…
October 22, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Finding Best Treatment for ‘Right Patient’ and Progressive MS Among Work of Interest, Cleveland Clinic Doctors Say Tailored, highly effective therapies early in the disease’s course may be a way forward in multiple sclerosis (MS)Ā treatment, according to Cleveland Clinic neurologist Robert Bermel. Another neurologist with the Cleveland Clinic,Ā Robert Fox, talked about potential and upcoming progressive MS treatments.Ā In interviews with Multiple Sclerosis News…
October 16, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Two European Studies Compare Tecfidera, Aubagio Effectiveness Treatment of relapsing-remitting multiple sclerosis (RRMS) patients with Tecfidera (dimethyl fumarate)Ā 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…
October 15, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Plasma Neurofilament Light Levels Linked to Treatment Effects in RRMS, Study Finds Levels of proposed biomarker neurofilament light chain (NfL) are associated with therapeutic effects of disease-modifying treatments (DMTs) inĀ relapsing-remitting multiple sclerosisĀ (RRMS) patients, according to a real-world study. Study findings also revealed that treatment with either Lemtrada (alemtuzumab, marketed byĀ Sanofi Genzyme),Ā Gilenya (fingolimod, marketed by Novartis), Tecfidera (dimethyl fumarate, marketed…
October 12, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018: Study Proposes Serum Neurofilament Light Threshold to Identify RRMS Patients at Risk of Worsening 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, āSerum neurofilament light (NfL)…
October 12, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 ā Early Relapses and Larger Lesions Increase Risk of Developing SPMS, Study Reports A higher frequency of early relapses, as well as a larger volume of lesions and older age at disease onset, increase the risk of transitioning from relapsing-remitting multiple sclerosis (RRMS) to secondary progressive MS (SPMS), according to a study. The study, āEarly cortical pathology and…
October 10, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Switching to Tysabri Leads to Fewer Relapses and Disability than Gilenya, Study in RRMS Patients Finds 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, āComparative effectiveness of switching…
September 20, 2018 News by Vijaya Iyer, PhD Rapamycin, Approved for Other Indications, Potentially Effective for MS, Study Suggests Treatment with Rapacan (rapamycin) decreased the size and volume of brain lesions in patients with multiple sclerosis (MS), an Iranian study reports. The study, āPromising effect of rapamycin on multiple sclerosis,ā was published in the journal Multiple Sclerosis and Related Disorders. Rapamycin, or sirolimus, is an immunosuppressive…
September 11, 2018 News by Ashraf Malhas, PhD MS Patients in Iran with Early-onset Disease Are Mostly Women with RRMS, Study Reports A study of Iranian patients with early-onset multiple sclerosis (MS) found women to be in the majority, optic neuritis to be the most common first disease symptom, and relapsing-remitting MS the most frequent disease course. The epidemiology ofĀ early-onset MS (typically, MS diagnosed before age 16; age 18 was the benchmark…
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 29, 2018 News by Jose Marques Lopes, PhD Poor Sleep Common in MS, Linked to Fatigue, Depression, and Anxiety, Study Reports Poor sleep quality is very common among patients with relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS), and is associated with a lower quality of life, and greater fatigue, depression and anxiety, according to a real-world study in patients treated with Betaferon (interferon beta-1b). The study, ā…
August 21, 2018 News by Patricia Inacio, PhD Deregulated RNA Molecules May Contribute to RRMS, Study Finds The levels of three small, regulatory RNA molecules ā long non-coding RNAs ā are deregulated in blood samples of patients with relapsing-remitting multiple sclerosis (RRMS), a study reports. The long non-coding RNAs are involved in the regulation of the natural immune response and DNA-damage response, supporting the theory that these…
August 20, 2018 Columns by Ed Tobias MS News That Caught My Eye Last Week: Lemtrada and B-cells, DMT Efficacy, Botox and the Brain, a Diet Recommendation Lemtrada Can Lower Number of B-cells Infiltrating Nervous System and Forming Clumps, Animal Study Shows I usually stay away from recommending articles about mice studies, but this article does a nice job of explaining how Lemtrada works and the role of B-cells in multiple sclerosis (MS). As…
August 10, 2018 News by Jose Marques Lopes, PhD Hair Loss Seen in RRMS Patients Using Aubagio Often Temporary and Mild, Study Says Hair thinning in relapsing-remitting multiple sclerosis (RRMS) patients usingĀ AubagioĀ is usually mild and temporary, and does not require stopping treatment, a small real-world study reports. The research, āReal-World Observational Evaluation of Hair Thinning in Patients with Multiple Sclerosis Receiving Teriflunomide: Is It an Issue in Clinical…
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."
August 2, 2018 News by Ana Pena PhD Multiple Sclerosis Patients Identify Symptoms that Worsen Quality of Life Loss of health-related quality of life is caused mostly by balance problems, muscle stiffness, and depression in people with relapsing-remitting multiple sclerosis (RRMS),Ā and for those with progressive MS, the causes are muscle rigidity, paralysis, weakness, and pain, according toĀ a…