treatment

Vitamin D may increase the therapeutic benefits of glucocorticosteroids (GCs) for multiple sclerosis (MS) through a protein complex called mTORc1, according to a study in a mouse model and in cells from MS patients. The study, “Vitamin D augments glucocorticosteroid efficacy via inhibition of mTORc1,” was presented…

Patients with relapsing-remitting multiple sclerosis (RRMS) who switch to Tysabri (natalizumab) after relapses on first-line treatment with other medications show greater relapse reduction and less disability progression than those switching to Gilenya (fingolimod), according to a real-world study. The research, “Comparative effectiveness of switching…

Treatment with disease-modifying therapies (DMTs) may benefit patients with secondary progressive multiple sclerosis (SPMS) who are actively experiencing relapses, as they can slow the disability’s worsening, a new analysis of an MS patient registry shows. Patients…

Merck KGaA will present the latest advances made on several of its therapies aiming to treat multiple sclerosis (MS) at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS). The conference is taking place through Friday in Berlin. The company, known as…

Novartis is seeking U.S. and European approval of its investigational oral agent siponimod to treat adults with secondary progressive multiple sclerosis (SPMS). The U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application, while the European Medicines Agency (EMA) has accepted for review…

Many of us have received help to pay for our MS medications. Now there’s a chance that assistance could be threatened. A recent article in the The Wall Street Journal reports that U.S. government prosecutors are looking into whether some pharmaceutical companies’ patient assistance programs are on the wrong…

Clinical data and real-world results support the long-term efficacy of Biogen’s medications for multiple sclerosis (MS), according to scientific presentations being released by the company. Specifically, findings support the effectiveness of Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) used early in the disease’s course, as well as the…

Treatment with Ocrevus (ocrelizumab) over five years lessened upper limb disability progression in primary progressive multiple sclerosis (PPMS) patients, reduced relapses and brain disease activity in patients with relapsing MS, and helped achieve no evidence of disease progression (NEDA) in a greater proportion of African-descent patients, compared to treatment…

Thousands of scientists, doctors, pharmaceutical company executives and others — representing about 100 countries — will meet for three days to discuss and debate the latest developments in multiple sclerosis (MS) at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, best known as…

A small group of multiple sclerosis (MS) patients with aggressive disease, who were treated with hematopoietic stem cell transplant in a clinical trial, reported a drop in their fatigue levels that researchers suggested was likely due to lesser inflammation. The study, “Autologous hematopoietic stem cell transplantation improves…

Emerald Health Pharmaceuticals announced that it has begun enrolling healthy volunteers for a Phase 1 clinical trial evaluating the safety and tolerability of EHP-101, a potential cannabidiol treatment for multiple sclerosis (MS) and scleroderma. The randomized, double-blind, and placebo-controlled study (ACTRN12618001390279p) will  investigate the safety and pharmacokinetics (how…

Ocrevus (ocrelizumab) is a serious disease-modifying therapy. It has the potential to deliver a major blow to a patient’s MS, but it also carries the possibility of severe side effects. The protocol for Ocrevus requires different doses on different infusion dates, following a specific treatment schedule. It’s also…

A 48-week treatment of relapsing multiple sclerosis (MS) with TG Therapeutics’ investigational compound ublituximab led to a marked reduction of brain and spinal cord lesions, massive depletion of relapse-associated immune B-cells, and significantly halted disability progression, according to results from a Phase 2 clinical trial. The data…

I saw my neurologist earlier this week. After my work-up, we sat and discussed how well I manage my multiple sclerosis. How well? No comment. Suffice it to say this disease is a worthy adversary. I have been feeling a little funky since that appointment. I have been looking to…

Smoking may increase multiple sclerosis (MS) disease activity, quicken disability progression, and speed the transition from relapsing to secondary progressive MS (SPMS) by as much as eight years, according to an MS Society review study. The review data shows that, although the U.K.’s National Institute for Health…

Four disease-modifying therapies (DMTs) for  multiple sclerosis — Avonex, Rebif, Betaferon, and Copaxone — are cost-effective and reduce disease progression in MS patients, especially those with relapsing-remitting disease, according to 10-year, real-world results from U.K.’s MS Risk Sharing Scheme (RSS). But the long-term benefits observed wane over…

Mylan announced its U.S. launch of dalfampridine extended-release (ER) tablets, the authorized generic version of Acorda‘s Ampyra, that work to improve walking abilities in adults with multiple sclerosis (MS). Both versions of this medication come in a 10 mg tablet form. Approved generic medicines are those that…

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended that Gilenya (fingolimod) be approved to treat children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS). If the CHMP opinion is accepted, Gilenya — marketed by…

Phase 3 Trial in the UK Soon to Test Statin, Simvastatin, in Slowing SPMS Progression I’ve taken a statin medication for years to keep my cholesterol in check. Now, a study is getting underway to see if one statin pill can also be used to treat MS. It’s particularly…

A brain training technique that helps boost processing speed was seen to significantly improve the cognitive capacity of multiple sclerosis (MS) patients, as well as their ability to perform everyday activities, a pilot study shows. The study, “A Pilot Study Examining Speed of Processing Training (SPT) to Improve…

Treatment with Rapacan (rapamycin) decreased the size and volume of brain lesions in patients with multiple sclerosis (MS), an Iranian study reports. The study, “Promising effect of rapamycin on multiple sclerosis,” was published in the journal Multiple Sclerosis and Related Disorders. Rapamycin, or sirolimus, is an immunosuppressive…

GeNeuro announced it has reacquired from Servier the worldwide rights to commercialize and develop the investigational humanized antibody GNbAC1 for the treatment of multiple sclerosis (MS). The decision came after Servier, a European company which, together with GeNeuro, developed the GNbAC1 program, declined to continue developing the therapy due to…

Editor’s note: Shortly after this column was published, Mylan pharmaceuticals announced it will begin distributing Dalfampridine Extended-Release Tablets, 10 mg, the authorized generic version of Acorda’s Ampyra. There’s been no word, yet, on what it will cost or how soon the generic will become available in pharmacies. A few…

The Multiple Sclerosis Society of Canada and the Multiple Sclerosis Scientific Research Foundation have awarded a $410,000 grant to fund research based on a new method for treating cognitive dysfunction in patients with progressive multiple sclerosis (MS). About 70% of progressive MS patients suffer from cognitive abnormalities that…

Remyelination therapies are on the horizon as an innovative multiple sclerosis (MS) treatment, according to my neurologist. These therapies have been on my radar the last few years, but to hear my neurologist say they could soon be a reality makes me hopeful of the possibilities. To offer a…

Two years of treatment with oral Gilenya (fingolimod) significantly reduced the rate of relapses when compared to Avonex (interferon beta-1a) intramuscular injections in children and adolescents with relapsing forms of multiple sclerosis (RMS), according to Phase 3 clinical trial results. Additionally, Gilenya (marketed by Novartis) decreased the number of central nervous…

A large Phase 3 trial getting underway at sites across the U.K. will test the effectiveness of simvastatin, a widely used oral statin, in possibly treating secondary progressive multiple sclerosis (SPMS), the study’s sponsor, University College of London Hospitals (UCLH), announced. The study, the largest ever undertaken for SPMS…

Phagocytes, diverse cells of the innate immune system, are known to both promote and prevent inflammation, depending on whether they are programed to damage tissue or to repair it. A study in mouse model of multiple sclerosis (MS) now reports that this programming is not fixed, and that pro-inflammatory…

Treating primary progressive multiple sclerosis patients with Ocrevus (ocrelizumab) led to a three-fold increase in the proportion of those showing no evidence of disease progression and no signs of inflammatory disease activity over more than two years of treatment, results of a Phase 3 trial show, and support new measures that might better capture disability in PPMS patients. The research, “Evaluation of No Evidence of Progression or Active Disease (NEPAD) in Patients With Primary Progressive Multiple Sclerosis in the ORATORIO Trial,” was published in the journal Annals of Neurology. Measuring disease progression in clinical trials and clinical practice requires reliable and comprehensible measures. Although widely used, the Expanded Disability Status Scale (EDSS, range 0-10) cannot fully capture changes in walking speed and hand or arm function, which are key determinants of overall disability in progressive forms of MS. No evidence of progression (NEP) is a newer measure that reflects the absence of disability progression, including upper limb function and walking speed. Maintaining NEP status means stable disease with no worsening in EDSS, in walking ability (assessed by the Timed 25-Foot Walk (T25FW) test, or the time it takes to walk 25 feet as quickly and safely as possible), and in upper limb function (assessed by the 9-Hole Peg Test (9HPT), a test of arm and hand dexterity). Patients with PPMS have less frequent signs of disease activity, which include relapses and brain lesions (assessed though magnetic resonance imaging or MRI). So scientists proposed a new measure — called “no evidence of progression or active disease” (NEPAD) — to evaluate both NEP and clinical and MRI measures of active disease. The researchers believe that NEPAD may represent a more sensitive and comprehensive measure of disease control in PPMS patients. The randomized, double-blind ORATORIO Phase 3 trial (NCT01194570) analyzed the efficacy and safety of Ocrevus — developed by Genentech, part of the Roche group — in 732 PPMS patients (age range 18–55). Results showed that Ocrevus treatment delayed the relative risk of disability progression by 25% compared to placebo, while also reducing the volume of chronic brain lesions and total brain volume loss. As a result, Ocrevus became the first therapy approved by the U.S. Food and Drug Administration and the European Commission for both PPMS and relapsing MS. Now, researchers assessed Ocrevus’ effect in PPMS patients included in the Roche-funded ORATORIO study using as trial goals changes in NEP and NEPAD. These people received either 600 mg of Ocrevus or placebo by intravenous (IV) infusion every six months for a minimum of 120 weeks (about 2.3 years). The trial’s main goal was time to onset of clinical disability progression (CDP) sustained for at least 12 weeks. CDP was defined as a 1.0 point or greater increase in EDSS score from a baseline (study start) score of 5.5 or less, or a 0.5-point increase from a baseline score greater than 5.5. NEP status, analyzed in 230 placebo- and 461 Ocrevus-treated patients, was defined as no evidence of CDP for 12 weeks, no 20% or more change in hand/arm function as measured by the 9HPT for 12 weeks, and no 20% or more change in walking ability as measured by the T25FW test for 12 weeks. "The 20% cut-off for progression on the T25FW test and the 9HPT has previously been shown to be a clinically meaningful magnitude of disease progression," the study noted. In turn, NEPAD — assessed in 234 placebo- and 465 Ocrevus-treated patients — included NEP, no brain MRI-measured disease activity, and no relapses. Relapses were defined as new or worsening neurological symptoms attributable to MS lasting longer than 24 hours and preceded by neurological stability for a minimum of 30 days. Brain MRI scans were conducted at baseline, and weeks 24, 48, and 120; new or enlarging T2 lesions and/or T1 enhancing lesions were considered evidence of MRI disease activity (T1 MRI imaging offers information about current disease activity by highlighting areas of active inflammation, while a T2 MRI image provides information about disease burden or lesion load). Overall, the majority of the PPMS patients analyzed experienced clinical disease progression or evidence of disease activity. From baseline to week 120, Ocrevus-treated patients who achieved NEP (42.7% of 461 people) or NEPAD (29.9% of 465)  — no disease activity or progression — were found to have lower T2 brain lesion volume and a lower EDSS score (lesser disability) compared to those with evidence of MS progression. They also had a slightly superior performance on the 9HPT and the T25FW test. Patients who reached NEPAD also showed fewer T1 lesions than patients with progressing or active disease. Compared to placebo treatment, the proportion of Ocrevus-treated PPMS patients maintaining NEP or NEPAD from baseline to week 120 was higher — for NEP, 42.7% versus 29.1% in the placebo group; for NEPAD, 29.9% versus 9.4% in the placebo group. These results showed that Ocrevus treatment increased the proportion of PPMS patients with NEPAD throughout the 120 weeks of the study by three-fold. “In conclusion, ocrelizumab (Ocrevus) increased the proportion of patients with PPMS with no evidence of progression and no clinical and subclinical disease activity compared with placebo,” the team wrote. “As such, NEPAD may represent a meaningful and comprehensive disease outcome in patients with PPMS.” However, data from ORATORIO's open-label extension and real-world data are needed to "determine whether NEPAD maintained throughout 120 weeks will translate into sustained NEPAD and enhanced protection against accrual of disability in patients with PPMS over the long term," the researchers concluded. Of note, five of the study’s 11 authors are employees and/or shareholders of Roche or Genentech.

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.