treatment

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.

The National Institute for Health and Care Excellence, better known as NICE, issued a final decision against including Ocrevus (ocrelizumab) as a treatment for primary progressive multiple sclerosis (PPMS) in the subsidized public health system for England and Wales. The agency’s “final appraisal,” which mirrors its draft…

Active Biotech announced it has regained global development and commercialization rights over laquinimod, its investigational oral therapy for multiple sclerosis (MS), from Teva Pharmaceuticals. Teva released rights to laquinimod after the company decided not to continue with its clinical development. Teva will give Active Biotech full…

B-cells in the immune system play an important role in the unfolding of inflammation and brain lesions in multiple sclerosis (MS), largely by how they influence the actions of another immune system cell, called T-cells, a new study reports. Its findings help explain why therapies…

Medical tourism is a term describing when people seek medical care by traveling from home countries to somewhere else. It’s an area of commerce that has existed for centuries, as people in ancient Greece once traveled to far away islands to visit healing gods. Medical tourism continues today, and…

Tysabri (natalizumab) was reported in a small retrospective study to significantly improve cognitive abilities in people with relapsing-remitting MS patients (RRMS) over two years of use. The study, “Improvement in Cognitive Function as Measured by NeuroTrax in Patients with Relapsing Multiple Sclerosis Treated with Natalizumab: A 2-Year…

Adults in Ireland with highly active relapsing multiple sclerosis (MS) now can be treated with Mavenclad (cladribine tablets, 10 mg), the first short-course oral treatment approved for this disease. The Irish Health Service Executive (HSE) has approved this new therapy and decided to reimburse patients for its associated…

Ocrevus, a disease-modifying MS treatment that’s only been on the market a little less than 18 months, appears poised to be a cash cow for its maker, Genentech. The research firm Spherix Global Insights, which analyzes trends in the pharmaceutical industry, predicts that Ocrevus is “poised to…

Spasticity scales may be insufficient to reflect the actual benefits of Sativex (nabiximols) treatment on spasticity symptoms in people with multiple sclerosis (MS), according to a small case series study. The results support the need to conduct a more extensive and functional examination to clarify treatment responses and help…

Medical cannabis has created a dilemma for medical providers who care for people who might benefit from its use. I’ve been thinking more about this lately because my home state of Ohio will have legal medical marijuana dispensaries starting on Sept. 8. The law passed in 2016, and it…

Tecfidera (dimethyl fumarate) and Gilenya (fingolimod) are equally effective in treating multiple sclerosis (MS), but Tecfidera shows higher rates of discontinuation, according to a real-world study. The study, “Discontinuation and comparative effectiveness of dimethyl fumarate and fingolimod in 2 centers,” was published in the journal Neurology Clinical…

MMJ International has filed two applications with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical studies testing its pharmaceutical grade cannabis-based therapies in easing symptoms associated with multiple sclerosis and Huntington’s disease. “The filing of these applications with the FDA brings us one step…

Gilenya (fingolimod) influences the release and function of small membrane particles, called extracellular vesicles, that are involved in the development of multiple sclerosis — and these vesicles may serve a biomarker of treatment effectiveness in people with relapsing MS, researchers report. Extracellular vesicles (EVs) may also work…

Abreos Biosciences announced the U.S. launch of moNATor, a laboratory-developed test that can help physicians monitor the levels of Tysabri (natalizumab) in patients with multiple sclerosis (MS). Tysabri (approved for relapsing forms of MS, by Biogen) administered at a dose of 300 mg every four weeks is known to be…

Carmen Navarrete, PhD, has been granted a Scientific Innovation Award for her post-doctoral presentation suggesting that the multiple sclerosis (MS) treatment candidate EHP-101 is anti-inflammatory and may boost remyelination, Emerald Health Pharmaceuticals announced. Navarrete, a senior scientist at Vivacell Biotechnology Espana, a company owned by Emerald Health Research, received the award at the…

Discontinuing Gilenya (fingolimod) treatment and starting on rituximab therapy may be more complicated than originally thought. A new report chronicles the medical journey of a man with multiple sclerosis (MS) treated with these drugs, and proposes a new treatment regimen. Both Gilenya (an approved MS therapy marketed by…

The neurologist who treats my MS is a woman. So is my primary care physician. I wouldn’t have it any other way, and an article in The New York Times makes me feel my decision is the right one. Patient studies tell the tale The Times article points…

Multiple sclerosis (MS) patients may experience severe disease exacerbation after switching from Novartis’ Gilenya (fingolimod) to Sanofi Genzyme’s Lemtrada (alemtuzumab), a case report suggests. This unexpected high disease activity raises questions about managing MS through the consecutive use of immunotherapies. The case report, “Unexpected high multiple…

As a 61-year-old woman diagnosed in 2010 with primary progressive multiple sclerosis (PPMS), I was overjoyed when the U.S. Food and Drug Administration (FDA) approved the therapy Ocrevus (ocrelizumab) in March 2017. Because Ocrevus is the first treatment approved to possibly slow the progression of PPMS, the FDA’s green…

Most patients with multiple sclerosis (MS) are satisfied with the conditions of their intravenous therapy (administered directly into the bloodstream) and are very aware of the therapy’s safety, according to a small Macedonian study. Also, establishing a specialized infusion center would substantially increase intravenous treatment satisfaction and adherence. The study, “…

Treating mice in a model of multiple sclerosis with Lemtrada (alemtuzumab) prevented the formation of B-cell aggregates in the animals’ central nervous system and disrupted already existing ones, researchers report. The treatment also reduced disease activity when administered at the peak of disease. The study, “Anti-CD52 antibody treatment depletes B…

Long-term treatment with disease-modifying therapies (DMTs) appears to lessen the risk of disease worsening in relapsing-remitting multiple sclerosis (RRMS) patients, an 18-year follow-up study suggests. But these therapies were not seen to benefit those who had progressed to secondary progressive multiple sclerosis (SPMS). The study, “Onset of secondary…

Botox injections in the bladder muscle increase the activity of brain regions involved in the sensation of urinary urgency in female multiple sclerosis (MS) patients who have neurogenic overactive bladder (NOAB), a new study shows. The study, “Higher Neural Correlates in Multiple Sclerosis Patients with Neurogenic Overactive…

Hair thinning in relapsing-remitting multiple sclerosis (RRMS) patients using Aubagio is usually mild and temporary, and does not require stopping treatment, a small real-world study reports. The research, “Real-World Observational Evaluation of Hair Thinning in Patients with Multiple Sclerosis Receiving Teriflunomide: Is It an Issue in Clinical…

TG Therapeutics announced it has reached target enrollment in the ULTIMATE I and II Phase 3 clinical trials assessing the use of ublituximab (TG-1101) to treat relapsing forms of multiple sclerosis (MS). Ublituximab is a modified anti-CD20 monoclonal antibody, which is designed to target a protein present on mature…

Results from a Phase 3 clinical trial show that urinary symptoms can be reduced significantly after treatment with low-dose Botox (100 units) in patients with multiple sclerosis (MS). That finding was reported in the study “Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS,” published in the…

AXIM Biotech announced that tests done on its cannabinoid-based chewing gum — MedChew Rx — showed both product stability and effective release of medicinal molecules, with a high percentage of its pharmaceutical ingredients available. These test results may be of importance, as the company is planning to bring MedChew Rx into clinical trials as a…

Pendopharm’s Glatect (glatiramer acetate injection), a lower cost alternative to Teva’s Copaxone, has been added to the public health plans of five Canadian provinces for patients with…

There are many things that confuse me, particularly in the medical area. Perhaps that’s why I am more comfortable thinking about MS patients’ quality of life rather than being into the hard science of medicine and understanding how medicines work. I’m thinking in particular of botulinum toxin, more…