disability

Genentech shared new insights into the workings of Ocrevus (ocrelizumab) and its effectiveness in reducing disease activity and slowing progression in relapsing and primary progressive multiple sclerosis (MS) at the recent 3rd Congress of the European Academy of Neurology (EAN). The new findings, previously reported here, built on analyses of information gathered during the three Phase 3 clinical trials assessing Ocrevus' safety and efficacy, as well as through monitoring patients in extension studies. The studies showed that nearly 40 percent of Ocrevus-treated relapsing patients and nearly 30 percent of primary progressive patients achieved NEPAD during the Phase 3 trials. In contrast, only 21.5 percent of those treated with Rebif and 9.4 percent receiving placebo achieved NEPAD — figures that demonstrate Ocrevus’ impact on patients’ lives, as well as Ocrevus’ ability to slow the decline in walking ability and other types of disabilities are comparable between patients with relapsing and primary progressive disease — data that demonstrate that the treatment acts on disease mechanisms that drive disability in both disease forms. How these effects play out in the long-term is the subject of ongoing research, as Genentech continues to follow these patients in an extension study. In addition, Ocrevus' prescription label strongly advises against pregnancy while on the treatment. Despite precautions, some women became pregnant during the trials. One of the meeting presentations narrated outcomes of these pregnancies; one healthy baby born at term and two ongoing pregnancies in women exposed to the drug. But while Genentech monitors women who become pregnant while on Ocrevus, the number of reported pregnancies is too small to draw conclusions about the treatment’s safety in pregnancy, and researchers do not know if Ocrevus also depletes B-cells in the fetus or in the baby born to a treated woman.

The over-the-counter antioxidant lipoic acid slowed brain deterioration in patients with secondary progressive multiple sclerosis (SPMS), according to a pilot study. An Oregon Health & Science University research team conducted the study, “Lipoic acid in secondary progressive MS.” It was published in the journal Neuroimmunology and Neuroinflammation. A hallmark…

Innate Immunotherapeutics' MIS416 has failed to help secondary progressive multiple sclerosis (SPMS) patients in a Phase 2 clinical trial. The company said it will continue testing the therapy, made up of natural compounds, to see if it can benefit any MS subgroups. Trial participants who received MIS416 had no meaningful improvements in neuromuscular function or the outcome of their disease, compared with those who took received a placebo. “It is disappointing that these results don’t show benefit for people with secondary progressive MS, for whom there are few treatment options,” Dr. Bruce Bebo, executive vice president of research at the National MS Society, said in a news release. Scientists hoped the injected therapy would modulate the activity of immune cells that affect the protective myelin coating around nerve cells, decreasing the inflammation and brain tissue damage associated with MS. Deterioration of the coating is a hallmark of the disease. The one-year trial (NCT02228213) tested the safety and effectiveness of MIS416 on 93 patients with SPMS in Australia and New Zealand. The patients randomly received MIS416 or a placebo once a week. There were no differences in the groups' scores on a disability index — the expanded disability status scale — or in brain volume changes detected by magnetic resonance imaging. In addition, there were no differences between in disease outcomes that patients reported. The self-reported barometers included the Multiple Sclerosis Impact Scale, the Neurological Fatigue Index, and the Brief Pain Inventory. "I am extremely disappointed by this outcome," Professor Pam McCombe, a principal trial investigator, said in a company press release. "Looking for measurable changes in patients with progressive MS using the assessment tools currently at our disposal is frustrating and complicated. We were hopeful that MIS416 would be an option to treat this group of patients who currently do not have effective treatment options." In addition to MIS416 failing to be effective, the group who received it had more treatment-related adverse events than the placebo group. The events were mainly related to the first dose, Innate said. The main problems were fever, chills, and muscle weakness. The company has been providing MIS416 to Australian MS patients under a compassionate use program. It said it will continue evaluating the safety and tolerability of the drug to see if it helps any subgroups of patients. Those findings will determine the future of the compassionate use program, it said. “These results are a shock, and definitely not what we were expecting based on our previous clinical experience with MIS416 and the reporting of treatment benefits we have received from many compassionate use patients over an extensive eight-year period," said Simon Wilkinson, Innate Immunotherapeutics' chief executive officer. "These data will be as distressing to them as they will be for all the stakeholders who were relying on the outcome of this study."

Ocrevus (ocrelizumab) significantly reduces disease activity and disability progression in patients with relapsing multiple sclerosis (MS) and primary progressive MS (PPMS), according to results of post-hoc analyses of Genentech’s Phase 3 clinical trial program assessing the drug.

Physical disability may have no link to brain lesion volume in some patients with multiple sclerosis (MS), concludes a recent study led by Dr. Rohit Bakshi, a neurology and radiology professor at Harvard Medical School. The study, “Characterizing Clinical and MRI Dissociation in Patients with Multiple Sclerosis,” appeared in the Journal…

Cigarette smoking is certainly no good for you, but it may not necessarily make your primary progressive multiple sclerosis (PPMS) worse, a new study finds. The study, “Smoking does not influence disability accumulation in primary progressive multiple sclerosis,” appeared in the European Journal of Neurology. It contradicts what was…

The National Multiple Sclerosis (MS) Society has selected research highlights from a recent MS conference in an effort to help make living with the disease less burdensome. Presentations from the May 24-27 annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in New Orleans — which ranged from advice on smartphone apps to diet…

Patients with secondary progressive multiple sclerosis (SPMS) have a higher burden of illness than patients with relapsing-remitting multiple sclerosis, a new study showed. The study, “Characteristics, burden of illness, and physical functioning of patients with relapsing-remitting and secondary progressive multiple sclerosis: a cross-sectional US survey,” appeared  in…

The National Multiple Sclerosis Society and a dozen other advocacy groups have banded together to support the Air Carrier Access Amendments Act of 2017, a bill seeking to strengthen the rights of airline passengers and close service gaps often faced by patients with disabilities, including those with multiple sclerosis (MS).

A high daily dose of simvastatin improves multiple sclerosis patients’ cognitive function, according to a new analysis of Phase 2 clinical trial results. The British team that did the research will start a study soon on whether simvastatin, which goes by the brand name Zocor and other labels, can also slow…

(Editor’s note: Tamara Sellman continues her occasional series on the MS alphabet with this second of two parts on terms starting with the letter “D.”) When it comes to multiple sclerosis, mastering an understanding of the disease means you need to mind your Ps and…

The casual remark, “You seem perfectly fine to me!” bothers me (and others) because eligibility for Social Security Disability benefits requires proving we are not fine. In fact, we must prove that we are disabled, which is no small burden when we “seem perfectly fine.” ‘Looking’ disabled An acquaintance of mine…

A real-world medical-facilities setting has confirmed clinical trial findings that Gilenya (fingolimod) can reduce multiple sclerosis relapses, according to a Spanish study published in Plos One. Gilenya, developed by Novartis Pharmaceuticals, was the first oral disease-modifying therapy to obtain U.S. and European approval. The Food and Drug Administration and European Medicines Agency authorized…

A Phase 3 clinical trial has been launched by MedDay Pharmaceuticals to investigate whether treatment with high-dose biotin (MD1003) may ease disability and improve mobility in non-relapsing primary or secondary progressive MS patients. The study is recruiting participants across the U.S., Canada and Europe. Biotin is a form of…

Loss of spinal cord neurons may not be a reliable tool to predict disability in patients with multiple sclerosis (MS), contrary to what was originally thought, according to researchers at Queen Mary University of London. Their study, “Axonal loss in the multiple sclerosis spinal cord revisited,” appeared in the journal…

A global Phase 3 clinical trial assessing MD1003 — also known as high-dose biotin — for progressive multiple sclerosis (MS) might lead to the approval of one of the first treatments helping select progressive patients to improve. The trial aims to prove that high-dose biotin can reverse disability in non-active progressive MS.

People with multiple sclerosis (MS) and others with spinal cord injuries and disorders will speak at the United Spinal Association’s upcoming 6th Annual Roll on Capitol Hill, which takes place June 11-14 in Washington, D.C. Andrea Dalzell, Ms. Wheelchair New York 2015, will be among those advocating for greater access to complex rehabilitation technology.

The burden of moderate-to-severe relapses in multiple sclerosis (MS) patients is underappreciated, according to a study sponsored by the pharmaceutical company Mallinckrodt. Researchers discussed the findings at the American Academy of Neurology’s 69th annual meeting in Boston, April 22-28. The title of the presentation was “The Economic Burden Of…

Although a Phase 2b trial of the remyelination drug candidate opicinumab (also known as anti-LINGO-1 and BIIB033) failed to meet its primary goal of improving disability in relapsing and secondary progressive multiple sclerosis (MS), researchers believe the drug did cause “fairly strong” improvements. The trial evaluated four doses of the…

Twenty years ago, the idea that B-cell depletion could treat multiple sclerosis would have been greeted with a hearty laugh by any well-respected neurologist or MS researcher — or perhaps a scoff. But times change and research advances. Today, a medicine that gets rid of certain B-cells may be the most powerful drug yet developed against…

People with secondary progressive multiple sclerosis (SPMS) are more likely to feel exhausted and have limited leg function than those without progressive MS as they age, a preliminary study suggests. The findings will be presented at the American Academy of Neurology (AAN) 69th Annual Meeting, set for April 22-28 in Boston.

Multiple sclerosis (MS) patients who smoke have a significantly worse quality of life than non-smoking MS patients, concludes a new study. Researchers presented the study, “Smokers with MS have greater decrements in quality of life and disability than non-smokers,” at the Americas Committee for Treatment and Research in…

Spending more time in the sunshine could make people with multiple sclerosis (MS) feel more energetic, though dietary vitamin D intake’s effect is mixed, depending on what type of MS a particular patient has. That’s the conclusion of a study — “Dietary intakes of vitamin D, sunshine exposure, EDSS and fatigue…

Two Phase 3 clinical trials investigating the long-term effects of Lemtrada (alemtuzumab) in multiple sclerosis (MS) patients showed the drug maintained improved outcomes, even in the absence of further treatment. Both studies were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2017 Forum, held…

Genentech’s Ocrevus (ocrelizumab) increased the proportion of patients with no evidence of progression (NEP) in the recently concluded ORATORIO Phase 3 clinical trial in patients with primary progressive multiple sclerosis (PPMS). The evaluation of NEP — a combined measure of three disability assessments — was a secondary exploratory endpoint of…

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…

A Phase 3 clinical trial evaluating the safety and effectiveness of ozanimod (RPC-1063) in patients with relapsing multiple sclerosis (RMS) shows treatment reduced the disease’s annualized relapse rate (ARR), researchers reported. The Phase 3 SUNBEAM trial (NCT02294058) tested ozanimod, an oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator designed to…

EMD Soreno has recently published Phase 3 clinical data showing that Cladribine tablets reduced the annualized rate of brain volume loss (BVL, brain atrophy) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS). The study, “Reduced brain atrophy rates are associated with lower risk of disability progression…

A newly concluded clinical trial gives scientific evidence of the benefits that a stem cell transplant holds for multiple sclerosis (MS) patients who fail to respond to medications — with researchers calling the procedure a reasonable option for those with high disease activity. Five years after the treatment — high-dose immunosuppressive therapy followed by autologous hematopoietic cell transplant — further disease…

When the Americans with Disabilities Act was signed into law in 1990, there seemingly were as many opponents as there were proponents. All these years later, the standards and expectations of that landmark legislation have become second-nature in mainstream America. Concerns about costs and consequences were…