December 2, 2022 News by Lindsey Shapiro, PhD Alcohol May Interfere With Tecfidera Metabolism, Study Finds Consuming alcohol around dosing time could limit the effectiveness of Tecfidera (dimethyl fumarate) for multiple sclerosis patients, a recent study suggests. Results from the study, which involved lab and mouse experiments, showed alcohol inhibits an enzyme in the liver that’s necessary to break down Tecfidera’s main ingredient, dimethyl…
October 1, 2021 Columns by Ed Tobias Humana’s Lawsuit Against Biogen Decries Ongoing ‘Seed and Sweep’ Schemes People living with multiple sclerosis know that the medications used to treat it are expensive. According to the National Multiple Sclerosis Society, the median annual price of brand-name disease-modifying therapies (DMTs) last year was $91,835. Five of them carried a price tag of more than $100,000 a year. Many pharmaceutical…
June 1, 2021 Columns by Jessie Ace Doctors Want Me to Switch Meds, But for Now, I’m Changing My Diet Doctors recently told me that the medication Iāve been taking for the last seven years for MS hasnāt been working. This is news that no one wants to hear.Ā When I first started Tecfidera (dimethyl fumarate), an oral tablet, I was…
February 1, 2021 Columns by Ed Tobias MS News That Caught My Eye Last Week: Pediatric MS, Rituximab, AHSCT, Zeposia Tecfidera Safe and Effective Over Long Term in Children With RRMS, Trial Shows In my view, too little attention has been paid to treating children and teens with MS between the ages of 10 and 18. Though things seem to be improving, only one disease-modifying therapy, Novartisā Gilenya (fingolimod),…
November 24, 2020 Columns by Jessie Ace How Lucy the Dog Changed My Life A pet is the most loyal companion a person can have.Ā Iām currently sitting in my dadās home office and typing away on my laptop. Itās nice to have a change of scenery. I brought my tiny dog, Lucy, with me as usual.
October 12, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Comparing DMTs, Myelin Repair, Hypertension Gilenya and Tecfidera Similarly Effective at Treating RRMS, Real-world Study Says Gilenya and Tecfidera are both oral disease-modifying therapies. Both meds attempt to limit the inflammatory action of the immune system. Both now have generic versions. And as this story reports, neither appears to have a leg up over…
July 6, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Wearable Sensors, COVID-19, Tecfidera PROTXX, University of Alberta Collaborate to Develop Remote Healthcare Platform for MS Patients As more and more neurologists turn to telemedicine for routine patient visits, I expect we’ll see more of the type of technology being developed here. This group is working on something that goes further than what…
June 23, 2020 Columns by Jessie Ace Being Free from Symptom Flares Makes Me Feel Like a Fraud Iām a fraud. Or at least I feel like one.Ā When writing for a site about multiple sclerosis and setting up a business focused on my diagnosis to help others in the same boat, it is a requirement that I…
April 14, 2020 Columns by Jessie Ace An April Fools’ Joke that Wasn’t Very Funny “I canāt move my head,” I thought.Ā It was 5 a.m. on April 1, and the realization of my full bladder prompted my wakening. But I soon realized I had a more significant issue that only became apparent when I tried to get up and couldn’t. What on…
February 4, 2020 Columns by Jessie Ace 5 Hacks to Help Manage Your Fatigue One of the most annoying MS symptoms is fatigue. Itās as unpredictable as the British weather and a constant balancing act. On energetic days we tend to do too much, depleting our energy for the next day. Running a business is no…
December 11, 2019 News by Joana Carvalho, PhD Tysabri May Promote Inflammatory B-Cell Activation in MS Patients, Study Says Tysabri (natalizumab), an effective T-cell targeting treatment for multiple sclerosisĀ (MS),Ā seems to also promote the activation of pro-inflammatory immune B-cells in people with this disease, a studyĀ found. The study, “Natalizumab promotes activation and pro-inflammatory differentiation of peripheral B cells in multiple sclerosis patients,” was published in the…
November 26, 2019 Columns by Jessie Ace From New Hope Emerged an Old Nightmare I was bruised, broken, and in pain. I had been struggling with Rebif (interferon beta-1a) side effects for over a year, ever since my diagnosis. It was the first multiple sclerosis medication doctors put me on, and it did not work…
November 4, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Vumerity Approval, Low Antibody Levels in MS Patients, GA Depot Trial, Tecfidera Study Vumerity Approved in US as Treatment for RRMS and Active SPMS By my count, Vumerity is the 18th disease-modifying therapy (DMT) that the U.S. Food and Drug Administration (FDA) has approved for multiple sclerosis (MS). It’s one of very few approved for secondary progressive MS (SPMS). I find…
October 30, 2019 News by Patricia Inacio, PhD Vumerity Approved in US as Treatment for RRMS and Active SPMS The U.S. Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate)Ā for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease (SPMS). Vumerity (previously known as ALKS 8700) was developed by Alkermes…
October 2, 2019 News by Patricia Inacio, PhD Profiling Inflammatory Markers in Cerebrospinal Fluid of Importance in Active MS, Case Study Finds Careful profiling of inflammatory markers in cerebrospinal fluid (CSF) of multiple sclerosis patients, coupled with standard exams and scans, helps in understanding disease evolution and treatment response, a case report suggests. It followed aĀ relapsing-remitting multiple sclerosis (RRMS) patient whose inflammatory markers in the CSF remained high over time, and…
September 19, 2019 Columns by Tamara Sellman Need to Know: What Is the JC Virus? Editor’s note: “Need to Knowā is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the forum topicĀ “Does PML worry you?” from April 18. The world of multiple sclerosis (MS)…
September 16, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Stem Cell Transplants, Remyelination Agent, Tecfidera Study, Plasma Exchange and Tysabri-linked PML It’s been a big week for interesting stories, as the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) has just concluded. The conference offered much to engage healthcare professionals and researchers, but the following are some presentations that appealed to me as a multiple…
January 14, 2019 News by Jonathan Grinstein Tecfidera Effective in East Asian RRMS Patients, Phase 3 Trial Shows Tecfidera (dimethyl fumarate) demonstrated strong efficacy in Japanese and other East Asian patients with relapsing-remitting multiple sclerosis (RRMS), a Phase 3 clinical trial shows. These results are consistent with previous clinical trials, whichĀ included mostly white MS patients, and show that Tecfidera can also be effective across various other patient demographics. Findings of the trial were reported in the study, āA randomized placebo-controlled trial of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis from East Asia and other countries,ā in the journalĀ BMC Neurology. Tecfidera, a delayed-release dimethyl fumarate capsule, marketed by Biogen, is an oral therapy approved in many parts of the world for the treatment of RRMS. In previous Phase 3 clinical studies, DEFINE (NCT00420212), and CONFIRM (NCT00451451), Tecfidera showed substantial effectiveness on clinical and neuroradiological measures in RRMS patients. The study participants were predominantly white (79% in DEFINE and 84% in CONFIRM), and there were 10% or fewer East Asian patients. In general, very little data is available on Tecfidera's effectiveness in East Asian MS patients. In this APEX Part 1 (NCT01838668) trial, researchers from the Kansai Medical UniversityĀ in Japan and Biogen evaluated the safety and efficacy of Tecfidera over 24 weeks (six months) in the treatment of RRMS patients from East Asia and other countries. Participants with active MS between the ages of 18 and 55, with ethnic origins in Japan, South Korea, or Taiwan were included. To compare East Asian and white MS patients, study enrollment was expanded to patients from Eastern Europe (Czech Republic and Poland). In all, the six-month, double-blind, placebo-controlled study recruited 225 patients, 142 of whom were East Asian (63.4%). It was completed by 213 participants. Patients were randomly assigned to receive Tecfidera, (240 mg, twice daily) or a matching placebo for six months. They were assessed at the beginning of the study, at three months, and again at six months. They underwent MRI (magnetic resonance imaging) scans for neurological examination, in addition to routine health checks. The primary objective of the study was the total number of new inflammatory lesions on brain MRI scans from three to six months. Secondary goals included the number of specific new, or newly enlarging T2 hyperintense lesions ā lesions reflective of damage to nerve cell connections ā from the beginning of the study to six months. Tertiary goals included standard safety measurements, and annualized relapse rate over six months. āWe chose radiological measures to serve as primary and secondary endpoints, due to the ability of MRI to detect lesions that might not produce clinical manifestations in the short-term,ā the researchers wrote. Results showed that Tecfidera treatment significantly reduced (84%) the total number of new MRI lesions from weeks 12 to 24 (primary objective), compared with placebo ā specifically byĀ 85% in the Japanese subgroup, 81% in the total East Asian subgroup, and 87%Ā in the Eastern European subgroup. Regarding the trial's secondary objective, the total number of new MRIĀ lesions from the beginning of the study up to six months was reduced by 75% in the Tecfidera group (78% in the Japanese, 76% in the East Asian, and 73% in the Eastern European subgroups), and the mean number of new/newly enlarging T2 hyperintense lesions was reduced by 63% in the Japanese, and 58% in the East Asian subgroups, compared with placebo. Most patients reported one or more adverse events (77% in the placebo group and 86% in the Tecfidera group). Most adverse events were mild or moderate in severity, and the ones affecting patients taking Tecfidera either related mainly to flushing symptoms or to gastrointestinal problems. The team concluded that the "results suggest that the strong efficacy and favorable benefit-risk profile of [Tecfidera] extends to Japanese and other East Asian patients with MS." The second part of the ongoing clinical trial, APEX Part 2, is an open-label extension trial ā where both the researchers and participants know which treatment they are getting ā designed to further examine the long-term safety and tolerability of Tecfidera in East Asian MS patients.
January 7, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Stem Cell Transplant, Cooling Therapy and Exercise, FDA OK for Generic Tecfidera, Top Stories of 2018 Stem Cell Transplant Lessens Disability and Relapses in RRMS Patients, Phase 2 Trial Shows Here’s another study indicating that a stem cell transplant should be a treatment choice available to all MS patients where medically appropriate. Isn’t it past time to press harder on the stem cell…
November 12, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: Ballet and MS, Salt and the Immune System, How Tecfidera May Work, Doctor-Patient Communications Exercise Program Based on Ballet Improves Motor Control and Balance in MS Patients, Study Reports It makes sense. Yoga helps multiple sclerosis (MS) symptoms, as do Pilates and simple stretching. So why shouldn’t ballet? After all, it requires similar balance and motor control. This study only involved…
November 2, 2018 News by Jose Marques Lopes, PhD Study Sheds New Light on Tecfidera’s Inhibitory Mechanism of Action Multiple sclerosis (MS) treatment Tecfidera (dimethyl fumarate) binds to a specific amino acid in key enzymes to inhibit their activity, according to a study that sheds more light on this therapy’s little-known mechanism of action. This newly identified regulatory mechanism may lead to the discovery of new compounds…
October 5, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 ā Biogen’s MS Treatments Found Safe, Effective in Clinical and Real-world Data Clinical data and real-world results support the long-term efficacy of Biogenās medications for multiple sclerosis (MS), according to scientific presentations being released by the company. Specifically, findings support the effectiveness ofĀ Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) used early in the disease’s course, as well as the…
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…
June 26, 2017 Columns by Ed Tobias MS News That Caught My Eye This Week: Brain Scans, Spasticity, Tecfidera Study and Cigarettes In case you missedĀ them, here are some news stories that appeared in MS News Today that caught my eye over the past week. **** Harvard Study Finds No Link Between Clinical Exams and MRIs in Some MS Patients I’m really not surprised…