April 23, 2021 News by Marisa Wexler, MS #AANAM ā Tysabri Improves Quality of Life, Can Reduce Infection Risk Editorās note: TheĀ Multiple Sclerosis News TodayĀ team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17ā22. GoĀ hereĀ to read the latest stories from the conference. Treatment with Tysabri (natalizumab) can improve mental and social health in people with multiple sclerosis (MS), according to new…
April 19, 2021 News by Vanda Pinto, PhD Tecfidera Approved in China to Treat Relapsing MS Tecfidera (dimethyl fumarate) was given the green light by health regulators in China to treat people withĀ relapsing multiple sclerosis (MS) ā clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The National Medical Products Administration’s (NMPA) decisionĀ came through a priority review of clinical trial data for Tecfidera,…
April 13, 2021 News by Margarida Maia, PhD Vumerity Linked to Better Quality of Life Than Tecfidera in RRMS Trial Vumerity (diroximel fumarate) is easier on the gastrointestinal tract than Tecfidera (dimethyl fumarate), and this translates into better quality of life for patients with relapsing-remitting multiple sclerosis (RRMS), a new analysis of EVOLVE-MS-2 trial data has found. The study, āImproved gastrointestinal profile with diroximel fumarate is…
April 8, 2021 News by Marisa Wexler, MS Under-the-skin Injection of Tysabri Approved in Europe The European Commission (EC) has approved a new method to administer Tysabri (natalizumab) as a treatment for people with relapsing-remittingĀ multiple sclerosis (RRMS). This new delivery route involves a subcutaneous injection in which Tysabri is injected under the skin. Compared with the previously approved intravenous (into the bloodstream) formulation,…
March 31, 2021 News by Patricia Inacio, PhD In Real World, Tysabri Lessens Disease Activity, Reduces Relapses in Pediatric-onset MS Off-label treatment with TysabriĀ (natalizumab) significantly lessens disease activity and reduces the number of relapses per year in patients with pediatric-onset multiple sclerosis (POMS), real-world data from Portugal show. The treatment also was considered safe in this population, in agreement with earlier studies. These findings support the usefulness…
February 22, 2021 News by Joana Carvalho, PhD Switch From Tysabri to Moderate-efficacy DMTs Linked to Worse Disability Patients with multiple sclerosis (MS) switching from Tysabri (natalizumab) to moderate-efficacy disease-modifying therapies (DMTs) are at a higher risk of showing signs of MS activity and experiencing disability progression than those switching to high-efficacy DMTs, a real-world study found. Based on these findings, the researchers are arguing that,…
February 19, 2021 News by Marta Figueiredo, PhD Drop in PML With Tysabri Use in Sweden Likely Due to Risk Management Plan The number of cases of Tysabri (natalizumab) that are associated with progressive multifocal leukoencephalopathy (PML) ā a serious brain infection ā in multiple sclerosis (MS) patients living in Sweden fell between 2006 and 2018, a study shows. Notably, the data highlighted that this drop was likely due to…
February 16, 2021 News by Marta Figueiredo, PhD Rituximab Before or During Pregnancy Not Linked to Major Complications Treatment with rituximabĀ before or during pregnancy was not associated with major pregnancy or infant complications, according to a case series of 19 women with multiple sclerosis (MS) and other autoimmune diseases. These findings add to the limited available evidence on the use of rituximab by expectant mothers either…
February 8, 2021 Columns by Ed Tobias MS News That Caught My Eye Last Week: Plegridy, Telemedicine, AI for MS, Myelin Repair FDA Approves Plegridy as Intramuscular Injection for Relapsing MS A common patient complaint about Plegridy has been that its subcutaneous injection procedure results in injection site reactions. This new formulation is delivered into the muscle, rather than under the skin. The needle is longer, but Biogen pharmaceuticals thinks the…
February 2, 2021 News by Marisa Wexler, MS FDA Approves Plegridy as Intramuscular Injection for Relapsing MS The U.S. Food and Drug Administration (FDA) has approved an intramuscular injectionĀ formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing forms of multiple sclerosis (MS). This formulation, for injection directly into muscle, is what is typically used to deliver the flu shot. According to Biogen, Plegridy’s…
January 29, 2021 News by Marta Figueiredo, PhD Tecfidera Safe and Effective Over Long Term in Children With RRMS, Trial Shows Long-term treatment with TecfideraĀ (dimethyl fumarate)Ā safely and effectively reduces the frequency of relapses in children with relapsing-remitting multiple sclerosis (RRMS), according to 2.5 years of data from the FOCUS Phase 2 trial and its extension study. These findings are consistent with those previously reported for adult patients, supporting…
January 21, 2021 News by Teresa Carvalho, MS New Study Will Assess Tysabri Effects on MS Cognitive Fatigue Researchers from the Kessler Foundation will launch a new study investigating the effects of Tysabri (natalizumab) on cognitive fatigue ā the type of fatigue that happens after strong mental concentration, such as in problem-solving ā in people with relapsing-remitting multiple sclerosis (RRMS). Cognitive fatigue, which is very…
December 22, 2020 News by Joana Carvalho, PhD Plegridy as Intramuscular Injection for RRMS Approved in Europe The European Commission (EC) has approved a new, intramuscular formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing-remitting multiple sclerosis (RRMS). This new mode of administration ā in which Plegridy is directly injected into the muscle, rather than under the skin (subcutaneously) ā does…
December 2, 2020 News by Joana Carvalho, PhD Tecfidera May Be Effective Option for Relapsing MS Patients Who Fail to Respond to Glatiramer Acetate Tecfidera (dimethyl fumarate) may be an effective treatment option for patients with early relapsing forms of multiple sclerosis (MS) who fail to respond adequately to glatiramer acetate, according to a post-hoc analysis of an observational study. The findings were reported in an article, āEffectiveness…
November 30, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: More Tysabri Benefits, Long-term Ocrevus Data, Trial Diversity, MS and the Gut Tysabri Affects Immune System Beyond Known MS Target, Study Finds Tysabri (natalizumab) slows multiple sclerosis progression by blocking some immune cells from entering the central nervous system, where they attack the myelin coating of nerves. Yet this study shows that Tysabri may also significantly reduce the number of proteins…
November 24, 2020 News by Aisha I Abdullah PhD Tecfidera Found in Breast Milk But Levels Appear Safe, Case Study Reports Tecfidera (dimethyl fumarate) was detected in the breast milk of two women using the oral therapy to treat their multiple sclerosis, but at concentrations well below the “theoretical threshold of concern” for an infant, a case study reported. According to its investigators, this is the first…
November 12, 2020 News by Marisa Wexler, MS Neurofilament Light Levels at First MS Event Can Predict Long-term Brain Atrophy The levels of the protein neurofilament light chain (NfL) in the blood when a person experiences a first demyelinating event associated with multiple sclerosis (MS) can predict brain atrophy up to a decade later, a new study shows. Titled “Association of Serum Neurofilament Light Levels…
November 9, 2020 News by Teresa Carvalho, MS Tysabri Superior to Gilenya at Easing Activity in RRMS, Study Reports Treatment with Tysabri (natalizumab) was more effective thanĀ Gilenya (fingolimod) in helping people with relapsingāremitting multiple sclerosis (RRMS) achieve no evidence of disease activity, a head-to-head study suggested. The study, “BEST-MS: A prospective head-to-head comparative study of natalizumab and fingolimod in active relapsing MS,” was…
November 9, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Age and DMTs, Tysabri or Gilenya, Sativex Trial, Ocrevus and Mayzent Phase 3 Trial of Sativex, Cannabis Extract Treatment for MS Spasticity, Opens in US This is a major step toward making a clinically tested, cannabis-based medication available in the U.S. I’ve always thought that medications containing a THC/CBD combination are useful to lessen some MS symptoms, but the lack…
November 5, 2020 News by Steve Bryson, PhD Tysabri Seen as Superior to Gilenya for RRMS in Limited, Head-to-head Study Adults with active relapsing-remitting multiple sclerosis (RRMS) treated with Tysabri (natalizumab) had fewer new and accumulated lesions, and a lower relapse rate than those treated with Gilenya (fingolimod) for 24 weeks, according to…
November 2, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Biotin, Opicinumab, Myelin, Tele-exercise MD1003 Fails to Prevent Disability Progression in Progressive MS Patients, Trial Shows This is discouraging news for people taking high-dose biotin, many who have been buying it over the counter. Not only do these researchers report that taking 100 mg of biotin (MD1003) three times a day failed to…
October 26, 2020 News by Marta Figueiredo, PhD Biogen Discontinues Development of Opicinumab for MS BiogenĀ is discontinuing the clinical development of opicinumab,Ā its experimental treatment candidate forĀ multiple sclerosisĀ (MS), based on data from the Phase 2 AFFINITY clinical trial. The announcement, amid a third-quarter report, indicated that the study failed to meet both its main and secondary goals, without further details. The trial,…
October 5, 2020 News by Marisa Wexler, MS Gilenya and Tecfidera Similarly Effective at Treating RRMS, Real-world Study Says Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are similarly effective at lowering the frequency of relapses and delaying disability progression in people with relapsing-remitting multiple sclerosis (RRMS), a real-world study from Switzerland reported. These efficacy measures were also consistent whether patients were new to aĀ disease-modifying therapy (DMT)…
September 29, 2020 News by Joana Carvalho, PhD FDA Approves Generic of Tecfidera for Adults With Relapsing MS The U.S. Food and Drug Administration (FDA) has approved Ciplaās dimethyl fumarate capsules, a generic version of Biogenās Tecfidera, to treat adults with relapsing forms of multiple sclerosis (MS), the company announced in aĀ press release. This generic is packagedĀ as 120 mg or 240 mg…
September 24, 2020 Columns by Jennifer (Jenn) Powell Restarting Rituxan: One Down, and a Lifetime to Go Last week, I again started my twice-annual infusion of Rituxan (rituximab). After 384 days without my disease-modifying therapy, my team decided I could no longer wait. In its absence, my symptomology had worsened. Halting progression trumped a pandemic, and with personal protective equipment in place, I begin…
September 16, 2020 News by Joana Carvalho, PhD #MSVirtual2020 – 13-year Data Find Tecfidera Safe, Reduces RRMS Relapses Long-term treatment with Tecfidera (dimethyl fumarate) continues to be safe and effective at reducing the frequency of relapses and disability progression in patients with relapsing-remitting multiple sclerosisĀ (RRMS), according to 13-year data from a Phase 3 extension study. The study findings were presented at MSVirtual2020 by Ralf…
August 26, 2020 News by Marta Figueiredo, PhD Infection Risk Higher for Ocrevus Than Rituximab, But Cancer Risk Lower Ocrevus (ocrelizumab), a second-generation anti-CD20 antibody, may be associated with a greater risk of infections. But it carries a lower risk of cancer and immune reactions than first-generation rituximab inĀ people with multiple sclerosisĀ (MS), according to a real-life study. The higher incidence of infections linked with Ocrevus’…
August 24, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Kesimpta, Ocrevus and Chickenpox, Generic Tecfidera, UTIs FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS The U.S. Food and Drug Administration’s approval of Kesimpta (ofatumumab) this month is a pretty big deal. Kesimpta is a once-a-month injectable disease-modifying therapy. There’s nothing else like it, because Kesimpta targets B-cells in the immune system. Until now, only…
August 20, 2020 News by Marisa Wexler, MS Mylan Launching Tecfidera Generic in US Mylan announced the launch of a first generic version of Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS). The generic, now approved by the U.S. Food and Drug Administration (FDA), is the first generic of any MS treatment available in an oral solid ā…
August 14, 2020 News by Forest Ray PhD 35% of Newly Diagnosed Patients Given DMT in Follow-up Years, US Study Finds Almost two-thirds of people newly diagnosed with multiple sclerosis (MS) in the United States, identified through a national database, were not prescribed disease-modifying therapies (DMTs) over an average of more than two years of follow-up, a real-world study of nearly 5,700 patients found. Current guidelines “recommend early treatment with…