August 17, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Ofatumumab, Aubagio, Oral DMTs, PoNS Device Ofatumumab Seen as Superior to Aubagio at Lowering Relapse Rates in Phase 3 Trials Ofatumumab is a cancer medication that’s awaiting approval by the U.S. Food and Drug Administration and the European Medicines Agency to treat MS patients. It’s delivered by injection once a month and aims to reduce…
August 12, 2020 News by Forest Ray PhD Aubagio Shows Long-term Safety, Efficacy in Relapsing MS Extension Study AubagioĀ (teriflunomide), taken as a 14 mg tablet once a day, shows long-term safety and efficacy in patients with relapsing forms of multiple sclerosis (MS), according to results of the Phase 3 TOWER extension study. Treatment was generally well tolerated by the 751 patients using Aubagio for a median…
June 16, 2020 News by Patricia Inacio, PhD Aubagio Safely Used by 5 MS Patients With Active COVID-19 Infection Five people with multiple sclerosis (MS) who tested positive for COVID-19Ā whileĀ being treated with Aubagio (teriflunomide)Ā Ā all developed a mild infection, had good outcomes, and experienced no disease relapses, a case study reported. These findings suggest that use of Aubagio, a disease-modifying therapy that acts on the immune system,…
May 29, 2020 News by Joana Carvalho, PhD Ofatumumab Lowers B-cell Counts and Helps Relapsing MS Patients Reach NEDA, Data Show Ofatumumab (OMB157) elicits a strong and fast reduction in the levels of circulating immune cells in people with relapsing forms of multiple sclerosis (MS), effectively helping to stop disease activity, according to new data from the Phase 2 APLIOS trial. The medication was also found to be more…
April 14, 2020 News by Marta Figueiredo, PhD Ocrevus Use Still Growing in Europe But Challenges on Horizon, Spherix Reports Prescriptions ofĀ RocheāsĀ OcrevusĀ (ocrelizumab) among multiple sclerosis (MS) patients initiating or switching aĀ disease-modifying therapy (DMT) continue to rise in Europe, according toĀ a surveyĀ conducted byĀ Spherix Global Insights. Ocrevus, an anti-CD20 monoclonal antibody administered directly into a vein,Ā was approved in the European UnionĀ to treat active forms…
December 20, 2019 Columns by Ed Tobias Who’s Willing to Accept More DMT Risk, You or Your Neuro? As more high-efficacy disease-modifying therapies (DMTs) are being made available, people with multiple sclerosis have to decide how much risk they’re willing to accept in exchange for the treatment’s potential benefits. It’s a tough decision not made any easier if a patient’s neurologist is unwilling to accept much risk.
September 18, 2019 News by Ana Pena PhD #ECTRIMS2019 ā Ponesimod Superior to Aubagio in Relapsing MS, OPTIMUM Trial Shows Actelion‘s ponesimod, an investigational oral treatment, is superior to Sanofi‘s Aubagio (teriflunomide) in lessening the frequency of relapses and easing fatigue symptoms in adults with active, relapsing multiple sclerosis (MS), results of the OPTIMUM trial show. These data will lay the ground for submissions…
September 18, 2019 News by Patricia Inacio, PhD #ECTRIMS2019 – Data Shows Ublituximab’s Long-term Safety in Relapsing MS, TG Therapeutics Announced Ublituximab continues to be safe and well-tolerated by people with relapsing forms of multiple sclerosis (MS) after a median follow-up of 124.7 weeks ā more than 2 years ā according to data from an extension Phase 2 trial. The data were shown in a…
September 17, 2019 News by Ana Pena PhD #ECTRIMS2019 ā Ofatumumab Superior to Aubagio in Lowering Relapse Rates and Lesions, Data Show Monthly under-the-skin injections of ofatumumab are superior to AubagioĀ (teriflunomide) to treat relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), leading to over 50% reduction in relapse rates, and more than a 90% reduction in active brain lesions, compared with Aubagio, results from ASCLEPIOS I…
September 9, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Cancer Medication Slows MS, Vitamin D and Myelin, Targeting ‘Helper’ T-cells, Vaccination Guidelines Ofatumumab Better at Easing Relapse Rates and Slowing MS Progression Than Aubagio, Phase 3 Data Show Ofatumumab isn’t approved as a multiple sclerosis (MS) treatment. It’s a cancer medication that’s marketed as Arzerra. But in two clinical trials reported here, it did better than Aubagio at treating MS. Its…
August 30, 2019 Columns by Ed Tobias Another Study Shows That Costs of Disease-modifying Therapies Are Zooming It probably comes as no surprise to you that the costs of some of the most popular MS medications have been soaring. A new study by researchers at the University of Pittsburgh reports that their list prices have more than quadrupled in a decade. And out-of-pocket costs rose even more.
June 18, 2019 Columns by Ed Tobias Some Neuros Make DMT Choice Harder than It Should Be More than 15 disease-modifying therapies (DMTs) are available in most high-income countries to treat multiple sclerosis (MS). DMTs come in the form of injectables, infusions, and pills. Some are new, others have been around for more than 20 years. Some have a greater possibility of serious side effects than others. Some DMTs are highly effective at slowing or stopping disease progression; others, not so much. It's a difficult choice to make. So, why are some neurologists making it harder? These doctors are handing their patients a medication "shopping list" and telling them to pick one. I see this topic discussed regularly in social media MS groups. Recently, a woman who needs to switch DMTs wrote that her neuro gave her a "handful of (medication) brochures" and told her to go home and decide which medication she wanted. Really? DMT selection shouldn't be do-it-yourself I've been using DMTs for more than 20 years. I've been on Avonex (interferon beta-1a), Tysabri (natalizumab), Aubagio (teriflunomide), and Lemtrada (alemtuzumab). I always had the final say on which med I wanted to use, but I never had to make that decision alone without guidance from my neuro. That's the way a doctor-patient relationship should work. While the final DMT decision should always rest with the patient, your neurologist has the responsibility to use his or her knowledge of the meds and of you to guide you in your choice. Some factors that you both need to consider are: Is the disease progressing quickly or slowly? Your lifestyle: Do you work full time? Do you have a good support system and reliable transportation? If an injectable DMT is in the mix, can you handle injecting yourself monthly, three times a week, or every day? How much possible risk are you willing to accept in exchange for the potential of a better result? An additional and criticial consideration is whether you can afford the treatment. My impression is that cost is rarely thought of or talked about before most physicians prescribe a medication. I see nothing wrong with asking your doctor how much you can expect to pay out-of-pocket. (Or, for the doctor's office to ask this of your insurance company). If you feel your neurologist doesn't know all of these things about you I suggest that you be proactive and fill in any blanks. The final choice is yours With all of that knowledge, you can probably narrow down the most appropriate DMT candidates for you to three or four. Then it's time for your neuro to clearly explain why those are the best choices and to review the pros and cons of each. Then, and only then, it's time for you to make the final choice. And your decision might be not to use any medication. That wouldn't be my choice, but it might be yours. After all, you're the one who'll be living with whatever choice you make. What has been your experience? Was your neurologist helpful when selecting a DMT or were you given "a handful of brochures" and told to do-it-yourself? How did you choose? You're invited to visit my personal blog at www.themswire.com.
June 11, 2019 News by Patricia Inacio, PhD Aubagio Targets Highly Metabolic Auto-reactive T-Cells, Study Shows AubagioĀ (teriflunomide), an approved medicine for relapsing forms of multiple sclerosis (MS), specifically targets highly metabolic and more autoreactive T-cells, analysis of the Phase 3 TERI-DYNAMIC clinical trial data shows. The findings, contrary to expectations, support a selective effect of Aubagio on different T-cell populations. The study āTeriflunomide treatment for multiple sclerosis modulates T cell mitochondrial respiration with affinity-dependent effectsā was published in the Science Translational MedicineĀ journal. In MS, immune cells, or lymphocytes known as T-cells, attack and destroy myelin, the fat-rich substance that wraps around nerve fibers (axons). Myelin loss creates lesions that affect nerves of the brain and spinal cord. Previous evidence suggested that T-cells, depending on their active or resting state, rely on specific ways of energy production or metabolism. Aubagio, marketed byĀ Sanofi Genzyme, is a well-known inhibitor of a mitochondrial enzyme called dihydroorotate dehydrogenase (DHODH), that is crucial for the activity of T-cells.Ā However, how Aubagio selectively targets the autoreactive T-cells is poorly understood. To shed light on this matter, an internationalĀ group of researchers used data from the TERI-DYNAMIC clinical trial that tested Aubagio in patients with relapsing form of MS to better understand how the therapy inhibited the patients' self-immune responses. The Phase 3, open-label TERI-DYNAMIC trial (NCT01863888) included 70 patients from Belgium, Germany, and The Netherlands, aged 18 to 56. Participants received Aubagio as a 14 milligram (mg) once-daily, oral dose, and researchers assessed the changes in immune cells' profile up to 24 weeks. Results showed that, contrary to what was expected, Aubagio was not generally decreasing T-cell levels in treated patients. Instead, it significantly reduced a particular subset of T-cells, called "Th1 helper cells." Moreover, researchers found that the diversity of T-cell receptors ā the surface proteins that can recognize a particular antigen (a protein that can elicit an immune response) ā making T-cells specific to a certain target was reduced in MS patients after treatment with Aubagio. These findings suggested that some T-cells were particularly susceptible to Aubagio. Using a mouse model for MS, the experimental autoimmune encephalomyelitis (EAE) model, researchers showed that the CD4+Ā T-cells (helper T-cells) and CD8+ T-cells, those that reacted most strongly against self-antigens, were the most sensitive to DHODH inhibition by Aubagio. Moreover, researchers saw that Aubagio was not affecting the production of pro-inflammatory molecules ā called cytokines ā at the cell level, but their overall decrease probably was due to the reduction in T-cell numbers. In line with these findings, CD4+Ā T-cells that produced the cytokine interferon gamma were significantly reduced with Aubagio treatment, whereas CD4+Ā T-cells that produced interleukin 17A were unchanged. This suggests that Aubagio is able to interfere with specific sub-types of immune cells. When the team compared the metabolic profile of T-cells from healthy subjects with that fromĀ patients with relapsing-remitting MS (RRMS) in both remission and in relapse phases, they found that the metabolism of T-cells from the last group was significantly altered, and thus targetable. Altogether, the results suggested that T-cells with a high-affinity to self-antigens are more susceptible to inhibition of the DHODH enzyme by Aubagio. āTherapeutic targeting of metabolic alterations might represent an attractive concept in MS, and might represent an as yet unrecognized key mechanism of teriflunomide-mediated immune modulation in this disease,ā the researchers concluded.
May 6, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Sexual Problems in Women with MS; Aubagio Satisfaction; Cellular Aging and PPMS Women with MS Have Higher Prevalence of Sexual Dysfunction, Study Reveals I’m surprised that someone felt it necessary to conduct a formal study of this. A glance at multiple sclerosis (MS) groups on social media, although unscientific, would suggest that this is a common problem. And if you’re going…
April 29, 2019 News by Santiago Gisler Relapsing MS Patients Highly Satisfied with Aubagio’s Efficacy and Ease of Use, Global Clinical Study Finds High levels of satisfaction with the efficacy and convenience ofĀ Aubagio (teriflunomide), an oral treatment for relapsingĀ multiple sclerosis (MS), were reported by patients across the U.S. and 13 other countries, a post-hoc analysis of data from a real-world Phase 4 study found. The study “Teriflunomide real-world evidence: Global…
April 25, 2019 News by Vijaya Iyer, PhD Aubagio Lowers Relapse Rate in RRMS Patients, Real-world Observational Study Shows In clinical practice, relapse events dropped by roughly half over a four-year period inĀ relapsing-remitting multiple sclerosisĀ (RRMS) patients treated withĀ Aubagio (teriflunomide), a real-world study reports. The study, āReal-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study,ā also examined patients’ perspectives in…
March 19, 2019 Columns by Ed Tobias 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…
March 5, 2019 Columns by Ed Tobias Two Different Approaches to Providing Online MS Help I received an email recently from the National Multiple Sclerosis Society in the U.S. promoting a searchable database of “credible doctors and resources.” A few days later, I happened to run across another online multiple sclerosis (MS) information service hosted by the HealthCare Journey website. They call it…
February 25, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Early DMT Use, Aubagio vs. Tecfidera, Lipoic Acid Study, MS Forums Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports The question of whether to start treating multiple sclerosis (MS) with an older, less effective disease-modifying therapy (DMT) and then move to a more effective one ā or use a heavy-hitting medication right…
February 20, 2019 News by Patricia Inacio, PhD Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports Multiple sclerosis (MS) patients given intensive disease-modifying therapies early in their disease course have more favorable long-term outcomes than those treated with an escalating regimen, real-world data shows. The study, āClinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis,ā was published in the journalĀ …
February 8, 2019 Columns by Ed Tobias DMT Approvals for Medicare Users Decline While Costs Rise, Study Shows This probably won’t come as a surprise to you if you’re on Medicare: It’s getting harder to obtain approval for many of the disease-modifying therapies (DMTs) prescribed for people with multiple sclerosis (MS). I see complaints about this all the time on social media. Now, research reported in…
December 7, 2018 News by Jose Marques Lopes, PhD Aubagio Becomes 1st Once-daily Oral DMT for Relapsing MS Patients in India AubagioĀ (teriflunomide) has become the first once-a-day, oral disease-modifying therapy (DMT) for multiple sclerosis (MS) to be approved for use inĀ India. Sanofi Genzymeās therapy is indicated for first-line treatment of relapsing MS. It should be taken each day with or without food, and patients in India will have…
November 20, 2018 News by Alice MelĆ£o, MSc FDA Approves Generic Version of Aubagio to Treat Relapsing MS, Glenmark Pharma Says The U.S. Food and Drug Administration (FDA) has approved a generic version of Ā Aubagio (teriflunomide) tablets at the 7 mg and 14 mg doses marketed by Sanofi, according to the generic’s manufacturer,Ā Glenmark Pharmaceuticals. The FDAās decision to approve the company’s application for teriflunomide tablets at two…
October 5, 2018 Columns by Ed Tobias Could Government Probe Threaten Pharma Patient Assistance Programs? Many of us have received help to pay for our MS medications. Now there’s a chance that assistance could be threatened. A recent article in the The Wall Street Journal reports that U.S. government prosecutors are looking into whether some pharmaceutical companies’ patient assistance programs are on the wrong…
May 9, 2018 Columns by Cathy Chester The Agony of Decision-making when It’s Time to Switch MS Medications Iām agonizing over an important decision and it’s driving me crazy. Iām usually a quick decision-maker, but this one is tough. I have my analytical hat on, trying to look at my choices from a scientific standpoint. Unfortunately, my anxiety kicks in, and my hat…
February 8, 2018 Columns by Tamara Sellman The MS Alphabet: Plaquenil, PML, Prevalence, and Other ‘P’ Words (Part 6 of 7) Editorās note: Tamara Sellman continues her occasional series on the “MS alphabet” with this column referencing terms starting with the letter “P.” This post comes sixth in a series of seven. Symptoms of MS Progressive multifocal leukoencephalopathy (PML) Though progressive multifocal leukoencephalopathy (PML) isnāt an actual symptom of MS,…
October 30, 2017 News by Patricia Silva, PhD #MSParis2017 ā Aubagio Can Help Slow Progression to an MS Diagnosis, Researcher Says Aubagio (teriflunomide)Ā can help to delay first clinical signs of multiple sclerosis (MS) from progressing to a definite diagnosis in a person, and treatment should likely begin as soon as that first episode is confirmed,Ā Robert Zivadinov, a professor of neurology and director of the Buffalo Neuroimaging Analysis Center, said…
October 27, 2017 News by Patricia Silva, PhD #MSParis2017 – MS Therapy Aubagio Does Not Appear to Cause Birth Defects, Study Reports Sanofi Genzyme’sĀ multiple sclerosis therapyĀ Aubagio (teriflunomide) does not appear to cause birth defects in humans as it does in laboratory animals, researchers concluded after studying more than 100 pregnant women with MS. Their research indicated that birth-defectĀ findings in rats and rabbits do not translate to humans. The team presented its…
October 23, 2017 News by Patricia Silva, PhD #MSParis2017 – Sanofi to Present Long-term Data on Lemtrada and Aubagio Use New data on how Lemtrada and Aubagio perform in a real-world setting will be the focus of Sanofi Genzyme when the company showcases its research at the upcoming 7th Joint ECTRIMS-ACTRIMS Meeting in Paris this week. Researchers will also share information about the safety of a new investigational therapy, GLD52 (GZ402668), currently in a Phase 1 safety study. The TOPAZ study is one of the main data sources for the upcoming presentations. The study, which follows relapsing MS patients who participated in the CARE MS-I and CARE MS-II extension study , is a rich source of information on long-term outcomes. Researchers will share various aspects of disease outcomes and magnetic resonance imaging (MRI) data from patients followed up to seven years, with some presentations focusing solely on those who switched from treatment with interferon beta-1a. Among the Lemtrada highlights are findings demonstrating that Lemtrada does not appear to trigger birth defects. Another presentation compared Lemtrada to Genentechās Ocrevus using a model that evaluated both the cost and effectiveness of the two drugs. The analysis suggests that Lemtrada more effectively treated relapsing MS and was also linked to lower costs over a 20-year period. Aubagio studies also focused on long-term patient data, including in people with progressive forms of relapsing MS. Data from the Phase 3 TEMSO , TOWER , and the TEMSO extension showed that Aubagio stabilized disability progression in these patients over nearly a decade. Other presentations homed in on Aubagioās ability to slow brain tissue loss and improve cognitive outcomes. Finally, Sanofi Genzyme shared initial data on its investigational antibody GLD52. The treatment is an updated form of Lemtrada, which scientists believe gives rise to fewer and milder infusion-related reactions. Data from the Phase 1 study , so far indicated that this might indeed be the case, as no severe reactions occurred in the 44 progressive MS patients in the trial. For a complete list of Sanofi Genzyme's presentations at the meeting, visit this link.
October 16, 2017 News by Patricia Silva, PhD Multiple Sclerosis Therapy Aubagio May Cause Nail Loss, Researchers Report Aubagio (teriflunomide) may lead to reversible nail loss, researchers at Italy'sĀ University of BolognaĀ reported after reviewing the case of a 55-year-old woman with relapsing-remitting multiple sclerosis. They described what happened to a patient who was referred to an MS clinic after experiencing acute optic neuritis ā or inflammation of the optic nerve ā three months earlier.Ā Their report, āNail loss after teriflunomide treatment: A new potential adverse event,āĀ was published in the journal Multiple Sclerosis and Related Disorders. Doctors had been treating the woman with intravenous methylprednisolone. Physicians had judged her slightly disabled, with an Expanded Disability Status Scale (EDSS) score of 3, but had not diagnosed her with MS. When she was diagnosed a few months later, she began receiving interferon beta-1a. It did not work, so doctors switched her to Sanofi Genzyme'sĀ Aubagio. At first, she tolerated the treatment well, having only slight nausea after taking the medication. Physicians did not detect signs of liver toxicity or high blood pressure, which are relatively common side effects of Aubagio. Roughly three months after starting the medication, however, the woman began having more trouble walking problems and had mild hair loss. Two and a half months later, she said her nails had started falling out in the past month. When doctors examined her, she had lost two nails, while others appeared to have stopped growing. They were thinner than normal and some had detached from the nail bed. In addition, her hair loss continued. She had not started using other drugs, new cosmetics, or changed her diet. A dermatologist excluded the possibility that the condition was the result of fungus, psoriasis, or other conditions that could cause nails to fall off. Because doctors suspected that Aubagio could be the cause of the nail loss, they recommended that she stopped taking it. The patient switched to Biogen'sĀ Tecfidera (dimethyl fumarate) after a couple of weeks, and her nails started to grow again. This supported doctorsā idea that Aubagio had caused the nail loss, and that it was reversible. Nail growth is similar to that of hair, researchers said. The patientās reaction could be an unusual version of the same process that makes people lose their hair when taking Aubagio, they said. Since nail loss is not described as a side effect of Aubagio on the medication's label, researchers urged MS specialists to consider the possibility if they see patients with the problem. Ā