safety

A first-of-its-kind study is aiming to determine whether older adults with multiple sclerosis (MS) can safely stop taking disease-modifying therapies, also known as disease-modifying agents (DMAs). The project is being led by scientists at the new P-HOPER Center, officially the Population Health Outcomes and Pharmacoepidemiology Education and Research…

The safety and efficacy of the approved multiple sclerosis (MS) therapy Mavenclad (cladribine) in a real-world group of patients were similar to what had been demonstrated in clinical trials, a new study reports. Among 243 people with relapsing-remitting multiple sclerosis (RRMS), more than 60% showed no…

The South Florida craft brew company 3 Mavins’ Beer is making it easy to support the Multiple Sclerosis Foundation’s programs and services on behalf of those who have the neurological disorder. Through a new partnership with the foundation, 3 Mavins’ is donating 3% of its profits from each can of…

There is minimal data available on the safety of most disease-modifying therapies for multiple sclerosis (MS) when used during breastfeeding, a new review indicates. The study “Disease-Modifying Drugs and Breastfeeding in Multiple Sclerosis: A Narrative Literature Review,” was published in Frontiers in Neurology. Disease-modifying therapies, or DMTs,…

NVG-291, an experimental therapy designed to promote nervous system repair, has so far been well tolerated in an ongoing Phase 1 study with healthy volunteers. “The Phase 1 study is progressing very well, and we are encouraged by the data we are seeing so far,” Daniel Mikol, MD, PhD, chief…

Other autoimmune conditions, particularly those characterized by the presence of anti-TPO antibodies, should not preclude patients with multiple sclerosis (MS) from receiving treatment with Lemtrada (alemtuzumab), according to an analysis of pooled data from clinical trials and post-market data. The study, “Autoimmunity and long-term safety and efficacy…

Treatment with evobrutinib, an experimental therapy for relapsing forms of multiple sclerosis (MS), reduced the size of inflammation-associated brain lesions in a Phase 2 clinical trial, data show. The oral medication was also found to be generally safe and well tolerated, according to an analysis of trial data in…

Ocrevus (ocrelizumab) reduces relapse risk and slows disability progression in multiple sclerosis (MS) but also is associated with higher hospitalization rates in older people with relapsing forms of the disease, a new observational study reports. Hospitalizations — which occurred mainly due to urinary tract infections — were more frequent…

Tecfidera has a lower risk of discontinuation due to treatment failure than Aubagio in people with multiple sclerosis (MS), a new observational study in Norway suggests. In the study, people receiving Tecfidera (dimethyl fumarate) were 38% less likely to experience treatment failure and stop use than those receiving…

Most patients with relapsing and progressive forms of multiple sclerosis (MS) are encouraged to get vaccinated against COVID-19 — and any vaccine of three authorized for use in the U.S. is safe to receive — according to recent guidance from the National MS Society. Despite mounting evidence that…

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,…

People with multiple sclerosis (MS) are among the high-risk groups advised to avoid dental amalgams — silver-colored fillings that are 50% mercury — under new recommendations issued by the U.S. Food and Drug Administration (FDA). Amalgams can be used by dentists to restore the structure and surfaces of teeth damaged by decay.

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 sclerosis (RRMS), according to 13-year data from a Phase 3 extension study. The study findings were presented at MSVirtual2020 by Ralf…

Low doses of rituximab, an anti-inflammatory medication used off-label to treat multiple sclerosis (MS), are safer and as effective as higher doses at reducing the frequency of relapses and the number of MS lesions, a clinical study shows. The study findings were presented at MSVirtual2020 by Luciana…

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 in people with multiple sclerosis (MS), according to a real-life study. The higher incidence of infections linked with Ocrevus’…

Aubagio (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…

Tecfidera (dimethyl fumarate) is safe and effective as a long-term treatment for relapsing-remitting multiple sclerosis (RRMS), a study of clinical trial data covering up to 11 years of treatment suggests. The study, “Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis:…

Five people with multiple sclerosis (MS) who tested positive for COVID-19 while being treated with Aubagio (teriflunomide)  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,…

Tysabri (natalizumab) is safe and shows robust, real-world effectiveness at reducing the frequency of relapses in people  with relapsing-remitting multiple sclerosis (RRMS), 10 years of data from a large, observational study report. Findings were reported in “Long-term safety and effectiveness of natalizumab treatment…

Transplanting patients’ own mesenchymal stem cells (MSCs) is a safe therapeutic approach and can delay disease progression in people with multiple sclerosis (MS), a meta-analysis review shows. The study also showed that cells transplanted to the spinal cord (intrathecal injection) were associated with significantly slower disease progression rates, compared…

A new clinical trial is comparing the best available therapies to an experimental stem cell therapy to treat severe forms of relapsing multiple sclerosis (MS). At the moment, more than a dozen therapies have been approved by the U.S. Food and Drug Administration for the treatment of relapsing forms…

Seven months after starting a safety review of Lemtrada (alemtuzumab), the Pharmacovigilance Risk…

Long-term treatment with Gilenya (fingolimod) in patients with relapsing forms of multiple sclerosis (MS) is safe and effective, results from a Phase 3 trial show. Trial findings were reported in the study, “Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results,” published in…

Editor’s note: This is the third story in a three-part report examining the question, “Is rituximab a reasonable alternative treatment for MS?”, which was a topic discussed at this year’s Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Here, we take an in-depth look…

Real-world data continues to support the safety and effectiveness of Mavenclad (cladribine tablets) in treating multiple sclerosis (MS), and several studies underway will help scientists gain in-depth understanding of how Mavenclad works, its impact on the immune system, and the durability of its benefits, an executive with EMD Serono said in an…

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 — more than 2 years — according to data from an extension Phase 2 trial. The data were shown in a…

Continuing Tysabri (natalizumab) treatment up to week 28 of pregnancy, and restarting soon after birth, reduces the risk of relapses in women with multiple sclerosis and appears to be safe for the mother and the baby, new research suggests. Doriana Landi, MD, PhD, from Italy’s University of…

Transplanting mesenchymal stem cells (MSCs) is safe and can delay disease progression in people with active, progressive multiple sclerosis (MS), according to results from a single-center clinical trial conducted in Israel. Six months after the transplant, a considerable proportion of patients showed no signs of disease activity, compared to…

Treatment with a potential remyelinating agent called liothyronine was safe and well-tolerated by people with multiple sclerosis (MS) in a Phase 1b trial. Preliminary results also suggested benefits in cognition, motor function, and fatigue. The study, “A Phase 1b, open-label study to evaluate the safety…

A Phase 1 clinical trial found T20K, Cyxone’s investigational plant protein-derived treatment for multiple sclerosis (MS), to be safe and well-tolerated in healthy men, and raising the possibility that it might work at low doses, the company announced. A next step is to develop an oral formulation for the…