Tecfidera (dimethyl fumarate)

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…

How Lucy the Dog Changed My Life

A pet is the most loyal companion a person can have.Ā  Iā€™m currently sitting in my dadā€™s home office and typing away on my laptop. Itā€™s nice to have a change of scenery. I brought my tiny dog, Lucy, with me as usual.

An April Fools’ Joke that Wasn’t Very Funny

“I canā€™t 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…

5 Hacks to Help Manage Your Fatigue

One of the most annoying MS symptoms is fatigue. Itā€™s 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…

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…

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…

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…

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…

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)…

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…

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, ā€œA 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. ā€œWe 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.

#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 Biogenā€™s 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…

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…