More than 90% of relapsing-remitting multiple sclerosis (RRMS) patients who received Immunic Therapeutics‘ experimental oral therapy vidofludimus calcium have not experienced confirmed disability worsening after nearly three years. That’s according to new data from the EMPhASIS Phase 2 clinical trial (NCT03846219) and its open-label extension (OLE)…

People with relapsing-remitting multiple sclerosis (RRMS) who report better physical health are significantly more likely to see disability progression after three years, an observational study found. The findings suggest this patient-reported outcome measure may help predict long-term disability worsening in people with the condition. “Our findings…

Ocrevus (ocrelizumab) was equally effective in reducing disease activity after two years in people with primary progressive multiple sclerosis (PPMS) and relapsing-remitting multiple sclerosis (RRMS), a new study reports. The therapy also slowed disease progression in both groups, although a stronger effect was seen with RRMS patients…

Researchers have created a computer program that can simulate clinical trial responses for relapsing-remitting multiple sclerosis (RRMS), which may improve clinical trial design for novel disease-modifying therapies. The tool, called MS TreatSim, was described in the study, “In silico clinical trials for relapsing-remitting multiple sclerosis…

The Scottish Medicines Consortium (SMC) has recommended that Ponvory (ponesimod) be offered through the National Health Service (NHS) Scotland to people with active, relapsing forms of multiple sclerosis (MS). The decision means that the oral therapy will be available at low or no cost to patients with clinically isolated syndrome (CIS),…

Cyxone Nears First-in-human Trial for Investigational Preventive MS Treatment T20K Multiple sclerosis can be treated but it can’t be prevented — at least not yet. But these researchers hope that a substance derived from a natural plant protein called T20K will be able to ease or even prevent MS…

As you might have heard, a disease-modifying therapy (DMT) for patients with active secondary progressive multiple sclerosis (SPMS) was approved a few days ago. That’s great news. A medication targeting SPMS is overdue, but it could be better. The DMT is Mayzent (siponimod), a tablet that’s taken…

Lemtrada (alemtuzumab) can sustain reduced activity and prevent progression of relapsing-remitting multiple sclerosis (RRMS) for more than seven years, clinical data from the CARE-MS extension trial shows. Findings were recently presented in four poster presentations at the 2018 Annual Meeting of the American Academy of Neurology (AAN) in Los Angeles. Lemtrada, marketed by Sanofi Genzyme, is an approved MS therapy that, according to its label, should generally be reserved for patients who have had an inadequate response to two or more other therapies. But the use of the word "generally" opens a window of opportunity “to use Lemtrada as a second-line therapy and potentially first-line therapy,” Barry Singer, MD, director of the MS Center for Innovations in Care at Missouri Baptist Medical Center, said in an email response to questions from Multiple Sclerosis News Today. The treatment was initially tested in two pivotal clinical trials in comparison with a high-dose under-the-skin injection of Rebif (interferon beta-1a) in RRMS patients. Participants were either new to treatment (CARE-MS I, NCT00530348) or had not responded to prior therapies (CARE-MS II, NCT00548405). During these trials, patients received 12 mg of Lemtrada for three or five consecutive days in two annual courses — at the beginning of the study and again one year later. After completing this treatment period, they had the opportunity to participate in a four-year extension study (NCT00930553) during which they could receive the therapy as needed to control their disease. Patients completing the extension could enroll in the five-year TOPAZ trial (NCT02255656) for further evaluation. To date, 80% of the participants (299 patients) from CARE-MS I and 73% from CARE-MS II (317 patients) have completed seven years of long-term follow-up. After completing two initial courses of Lemtrada, 59% of patients from CARE-MS I and 47% from CARE-MS II did not require additional treatment courses with Lemtrada or other disease-modifying therapies during the next six years. Two-thirds of  CARE-MS II patients who required a third Lemtrada course also experienced disability stabilization one year after the last treatment. During the seven years of follow-up, reported annualized relapse rates remained low, and 37% of patients from CARE-MS 1 and 44% from CARE-MS II experienced confirmed improvements in disability. In fact, during this period, only 26% from CARE-MS 1 and 31% from CARE-MS II showed disability worsening. The treatment also had a sustained effect on slowing brain volume loss by the seventh year, with a median yearly brain volume loss of 0.20% or less from the third to seventh year. This effect was found to be even better than that reported during the initial two years of treatment in the pivotal studies (0.59% in the first year and 0.25% in the second year in CARE-MS I, and 0.48% in year one and 0.22% in year two in CARE-MS II). Additionally, evaluation by magnetic resonance imaging (MRI) showed no signs of disease activity during the seven years of follow-up. “The extension study data being presented at AAN illustrate that more than two-thirds of patients did not experience confirmed disability worsening at year seven after initiating treatment with Lemtrada,” Singer said in a press release. “In addition, consistent effects were maintained over time across relapses and MRI outcomes including brain volume loss, even though the majority of patients did not receive any additional treatment over the prior six years.” During the extension studies, the frequency of adverse events was similar to that reported during the pivotal studies. In seven years, three deaths occurred, none of which was considered to be treatment-related. Thyroid adverse events were reported to be more frequent by the third year, but declined thereafter. As Singer noted, "the serious risks of Lemtrada, including serious infusion reactions, serious infections, thyroid disease, kidney disease, low platelets and potential malignancies, must always be discussed with the patient." All patients should also be carefully monitored on a monthly basis for four years after the last treatment course “to screen for autoimmune complications, including low platelet counts, thyroid disease, and kidney disease,” he said. Lemtrada’s long-term effects were shared at the AAN annual meeting in these presentations: “Active RRMS Patients Treated with Alemtuzumab Experience Durable Reductions in MRI Disease Activity and Slowing of Brain Volume Loss: 7-Year Follow-up of CARE-MS II Patients (TOPAZ Study)” “Durable Clinical Outcomes With Alemtuzumab in Patients With Active RRMS in the Absence of Continuous Treatment: 7-Year Follow-up of CARE-MS II Patients (TOPAZ Study)” “Durable Reduction in MRI Disease Activity and Slowing of Brain Volume Loss in Alemtuzumab-Treated Patients With Active RRMS: 7-Year Follow-up of CARE-MS I Patients (TOPAZ Study)” “Durable Clinical Efficacy of Alemtuzumab in Patients With Active RRMS in the Absence of Continuous Treatment: 7-Year Follow-up of CARE-MS I Patients (TOPAZ Study) Lemtrada is approved in more than 60 countries, and has additional marketing applications under review by regulatory authorities worldwide.

A one-year analysis of the ongoing Phase 3 EVOLVE-MS-1 trial of ALKS 8700 as a therapy for relapsing remitting multiple sclerosis (RRMS) supports the experimental therapy’s effectiveness, with the treatment significantly reducing the number of MS lesions. Interim results from the trial were presented Tuesday at the…

Most multiple sclerosis patients who try Bayer’s BETACONNECT auto-injector stick with their treatment, a study reports. The electronic product may overcome the problem of many patients failing to stick to a therapy  schedule because of what they consider hassles connected with injections. An auto-injector is one that patients can use…

RedHill Biopharma, Ltd., an Israeli biopharmaceutical company focused on the development and commercialization of oral-administered small-molecule medicines for the treatment of inflammatory and gastrointestinal diseases, recently announced it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering its…

Teva Pharmaceutical Industries Ltd. and Active Biotech have discontinued the use of higher doses of the drug laquinimod in two ongoing multiple sclerosis (MS) studies. The decision was based on a recommendation by the Data Monitoring Committee (DMC) that is supervising the clinical trials after cardiovascular events, none of which were fatal,…