brain lesions

Recovering well after a first relapse and starting a disease-modifying therapy (DMT) immediately afterward considerably increases the likelihood of slowing progression in multiple sclerosis (MS), a study suggests. Its findings support relapse recovery as a critical factor for DMT initiation, and one that should be assessed routinely in MS…

A new diagnostic method for multiple sclerosis (MS) that uses 3D analysis of a patient’s brain may be able to tell physicians which lesions there are more likely to heal with time and which are not, and as such could be a game-changer in treating the disease, according to the…

Early and continuous treatment with Gilenya (fingolimod) in young  people — those ages 30 years or younger — with relapsing-remitting multiple sclerosis (RRMS) decreases the risk of disability progression, and lowers annual relapse rates and brain lesions, new analysis from the FREEDOMS and FREEDOMS II trials show. The…

An application has been submitted to approve ozanimod as an oral treatment for adults with relapsing forms of multiple sclerosis in the U.S., according to its developer, Celgene. “New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” Jay Backstrom, MD, Celgene’s chief medical officer, said in a press release. Celgene's New Drug Application has been submitted to the U.S. Food and Drug Administration. Earlier this month, the company submitted a marketing authorization application to the European Medicines Agency covering the treatment of adults with relapsing-remitting MS. “With concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of (relapsing MS) in 2020,” Backstrom said. Ozanimod is designed to cause the retention of immune cells in lymphoid tissues, thereby blocking their migration to the central nervous system — brain and spinal cord — and preventing damage to nerve fibers and their protective layer, called myelin. The investigational therapy selectively binds to S1P receptor subtypes S1P1 and S1P5. The NDA application is based on positive findings from two multicenter, double-blind, Phase 3 trials called SUNBEAM and RADIANCE part B. Both studies demonstrated that ozanimod reduced the number of relapses and brain lesions. In the SUNBEAM Phase 3 trial, 1,346 participants with relapsing MS were randomized to one daily dose of 0.92 or 0.46 mg of ozanimod — equivalent to 1 mg and 0.5 mg of the therapy’s HCI formulation — or Avonex (interferon beta-1a, marketed by Biogen) for at least 12 months. Results showed that treatment with ozanimod led to fewer relapses and brain lesions, as well as clinically meaningful improvements in processing speed compared with Avonex. In the Phase 2/3 RADIANCE trial, patients were divided in two parts: in part A, participants received either one daily dose of ozanimod (0.5 mg or 1.0 mg) or a placebo for 24 weeks; in part B, a 96-week open-label extension study completed by 223 patients, those initially on placebo switched to ozanimod. As in the SUNBEAM trial, results of part A of the RADIANCE trial revealed a reduction in the number of brain lesions from weeks 12 to 24, as well as less frequent relapses compared with a placebo. Treatment with ozanimod was safe and well-tolerated. Findings of part B of the study included an increased percentage of patients free of T1 lesions on MRI (magnetic resonance imaging) scans — which refer to areas of active inflammation and disease activity — after two years of treatment, from 58.5–69.0% of patients in part A to 86.5–94.6% of patients in part B. T2 lesions, a measure of the total amount of MRI lesions — both old and new — and relapse rate remained low in patients maintained on ozanimod (more significantly with the higher dose of 1.0 mg), and dropped in those who switched from a placebo. The scientists also analyzed ozanimod’s benefits using data from the SUNBEAM and RADIANCE part B trials, which covered 2,659 patients treated over one to two years. Compared with Avonex, ozanimod reduced the annualized relapse rates — the number of relapses per year — by 42% in the higher dose group and 26% in the lower dose group. Treatment with ozanimod also lessened the relapse rate requiring steroid treatment or hospitalization by 43% (in the 1 mg dose group) and 26% (in the 0.5 mg dose group) compared with Avonex treatment. In addition to MS, ozanimod is also being developed for patients with ulcerative colitis and Crohn's disease, two inflammatory bowel diseases.

Evobrutinib, Merck KGaA’s oral candidate for relapsing multiple sclerosis (MS), is safe and can significantly reduce active brain lesions over 24 weeks of treatment, results of ongoing Phase 2 study show. Xavier Montalban, PhD, MD, with Vall d’Hebron University Hospital in Barcelona, presented the results in the talk “Primary…

I’ve often wondered if there may be a connection between fibromyalgia, multiple sclerosis (MS), and other neurological conditions. Back in the early 1990s, my doctor suspected fibromyalgia as the culprit for my fatigue, aches, and pains. At the time, doctors diagnosed fibromyalgia by the use of tender points.

Genetic variants in the CPXM2, IGSF9B, and NLRP9 genes were found to potentially shape the disease course of multiple sclerosis (MS), and may be used as biomarkers to identify those with an aggressive or…

Apolipoprotein D (Apo D), a brain-produced carrier of fat molecules, seems to have a neuroprotective role and helps in the regrowth of myelin during multiple sclerosis (MS), a finding that may help develop new therapeutic approaches to fight the disease, new research shows.

Atrophy (shrinkage) of brain lesions correlates with physical disability in patients with multiple sclerosis (MS), new research reports. The study, “Atrophied Brain Lesion Volume: A New Imaging Biomarker in Multiple Sclerosis,” was published in the Journal of Neuroimaging. Magnetic resonance imaging (MRI) scans are used routinely on MS patients…

A formulation of ofatumumab (brand name Arzerra) to be injected under the skin (subcutaneous) was found to be safe and effective in the treatment of relapsing-remitting multiple sclerosis (RRMS), even when given at lower doses…

Professor Frederik Barkhof, MD, PhD, has won the 2018 John Dystel Prize for Multiple Sclerosis Research for pioneering the use of magnetic resonance imaging (MRI) to improve multiple sclerosis (MS) diagnosis and understanding of the disease. The prize, decided by a peer committee, is awarded annually by…

So-called silent brain lesions in patients with early-stage relapsing-remitting multiple sclerosis (RRMS) may, in fact, not be silent at all, according to a French study that linked such lesions to cognitive decline in early MS. This link has likely been missed since the major tool for measuring disability in MS…

A Phase 2b trial assessing the experimental retroviral-targeting treatment GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS) failed to meet its primary goal of reducing brain lesions and other signs of brain inflammation within six months. But researchers at GeNeuro and Servier — the two European companies that jointly developed the drug…

Lemtrada (alemtuzumab) may be an effective option for relapsing-remitting multiple sclerosis (RRMS) patients withdrawing from prior treatment with Tysabri (natalizumab), an Italian study shows. The study, “High-Risk PML Patients Switching from Natalizumab to Alemtuzumab: an Observational Study,” appeared in the journal Neurology and Therapy. Tysabri, an antibody with…

Multiple sclerosis patients who start Rituxan (rituximab) treatment are three times more likely to have unchanged or improved brain-scan readings than worse ones, according to a study. Holy Name Medical Center researchers presented the findings at the Consortium of Multiple Sclerosis Centers annual meeting in New Orleans, May 24-27. The presentation…

Cladribine tablets reduced relapsing multiple sclerosis patients’ annual relapse rate by 55 to 57 percent, depending on the dose, according to clinical trials. EMD Serono, a unit of Cladribine’s developer, Merck, presented the trial results at the 31st annual meeting of the Consortium of Multiple Sclerosis Centers in New Orleans,…

Treatment with Apitope’s lead agent, ATX-MS-1467, decreased brain lesions in patients with relapsing multiple sclerosis (MS) in a now-completed Phase 2a clinical trial. ATX-MS-1467 is a potential disease-modifying agent with an immune-tolerating action. It consists of four short peptides derived from the myelin basic protein, and is designed to reduce…

Progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients treated with Tysabri (natalizumab) is linked to better outcomes if the condition does not give rise to actual symptoms and is diagnosed early. Limited brain lesions and more protective immune responses were also seen in patients who fared better, but researchers…

Apitope and Merck KGaA announced that they have entered into an exclusive agreement regarding ATX-MS-1467, a potential disease-modifying therapy for  multiple sclerosis (MS). Under its terms, Apitope will regain full global rights over ATX-MS-1467, as well as all clinical data related to the compound. In 2009, the company granted exclusive global rights to Merck KGaA to develop…

A presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016 Congress gave patients with progressive multiple sclerosis (MS) a reason for optimism, as Novartis reported that siponimod (BAF312) reduced the risk of disability progression in a Phase 3 study of patients with secondary progressive (SP) MS.

Coherus BioSciences recently reported that its candidate therapy for multiple sclerosis (MS), CHS-131, reduced the development rate of new brain lesions by nearly 50% in previously untreated relapsing-remitting MS patients. The Phase 2b trial (NCT02638038), randomizing patients to receive either CHS-131 or placebo in a double-blind manner, also showed the…

Researchers at the Swedish Neuroscience Institute in Washington and Novartis Pharma revealed that Gilenya (fingolimod) induced a consistent and significant reduction in disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). The results were recently presented at the June 1-4 Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual…

Taste deficits are considerably more prevalent in multiple sclerosis (MS) patients than previously thought, and correlate directly with the severity of MS-related brain lesions, researchers report in an article titled “Taste dysfunction in multiple sclerosis,” published in the Journal of Neurology. Sensory problems are common MS symptoms, with…

Synthetic Biologics, Inc., a clinical stage company focused on the development of therapeutics to protect the microbiome and to target disease-causing pathogens, recently announced disappointing results from an independent third-party analysis of a Phase 2 clinical trial evaluating Trimesta as a treatment for relapsing-remitting multiple sclerosis (RRMS) in women.

A number of studies have previously suggested a negative effect of high cholesterol levels on the development of brain lesions in patients with multiple sclerosis (MS), however, little is known about the effect of HDL (high-density lipoprotein) cholesterol, or “good” cholesterol, on MS. A team of scientists from the University…

The common symptom of fatigue experienced by multiple sclerosis (MS) patients may be caused by regional damage in the brain, according to research conducted at the Vita-Salute San Raffaele University in Italy and published in the journal Radiology. Scientists analyzed atrophies and lesions in the white matter and grey matter of 65…

New research work from GlaxoSmithKline presented by Daren Ausin, PhD, at the American Academy of Neurology’s 66th Annual Meeting has implications for individuals with relapsinig-remitting multiple sclerosis. The presentation detailed a study that used GlaxoSmithKline’s ofatumumab in 231 patients with relapse-remitting multiple sclerosis. Ofatumumab is an anti-B-cell antibody, and it…