Vijaya Iyer, PhD,  —

Even at a low level of disability, people with multiple sclerosis (MS) have substantial indirect and informal caregiving costs due to disease progression — with unemployment markedly adding to the economic burden, a Spanish study reports. The study, “Economic burden of multiple sclerosis in a population with low physical disability,” was published in the journal BMC Public Health. MS has significant impact on health-related quality of life, with disability and fatigue — two hallmarks of the disease — hindering patients' ability to work or study. This often results in early unemployment. As MS progresses, many individuals often need the support of caregivers to perform daily life activities. Limited information is available on MS-associated economic burden imposed on patients by the costs of informal care and loss of employment. To fill this gap, Spanish researchers evaluated the cost burden of indirect and informal care for 199 people with MS. Participants (mean age 43.9 years, and 60% females) were followed at 19 MS clinical units across Spain. Among the participants, 172 (86.4%) had relapsing-remitting MS, and 27 (13.6%) had primary progressive MS. The Expanded Disability Status Scale (EDDS) was used to determine each individual’s level of disability. EDDS scoring is done by a trained neurologist, who quantifies a patient’s disability on a scale of zero to 10, in 0.5 increments.  EDDS also is used to monitor changes in disability levels through the course of MS. The greater the EDDS score, the higher the disability level. The team used the 23-item MS Work difficulties questionnaire (MSWDQ-23) to assess the level of hardships participants experienced at their workplace. A patient-reported survey, the questionnaire highlights the extent of psychological and cognitive, physical, and other external difficulties experienced at work by people with the disease. MSWDQ-23 scores range from zero to 100, with a higher score correlating to more significant workplace difficulties. The study population had a median EDDS score of 2, and a median MSWDQ-23 score of 31.5, indicating an overall low level of physical disability. Despite this, MS was found to have a marked impact on the individuals’ work and academic activity. At the time of MS diagnosis, 70.6% of the participants were employed. However, at the start of this study, 9.6 years later, the employment rate among the participants had dropped to 47.2%. The retirement rate increased from zero at the time of diagnosis to 23.6% at the time of study visit. Most participants retired at a mean age of 43.6 years — and 95.7% of them cited MS progression as the reason for retirement. Among the student population, 90.9% reported absenteeism in the year before the study visit. During the same time period, 30.9% of employed participants were absent from work. Overall, 10.1% of all participants took sick leaves during the prior year. Being absent from work, and early retirement, impose several indirect costs in this study population, the researchers found. Sick leave due to MS resulted in a mean annual cost of €416.6 (US$473.59), while work absenteeism accounted for €763.4 (US$867.83) yearly. Early retirement due to MS added an additional mean annual cost burden of €5,810.1 (US$6,604.92). The annual costs per patient due to premature work disability or pension increased to €1,816.8 (US$2,065.34). Caregivers accompanied 72% of the patients for the study visit. The researchers noted that participants' spouses reportedly spent a minimum of more than 200 hours annually in providing care — more than a full-time job. A total 28.1% of participants required paid professional support for their daily activities, such as person to do housework and a physiotherapist. Patients also reported the use of assistive devices and adaptations. Crutch or walking stick use was reported by 10.6% of participants, while 8% had some home adaptation to help in their daily activities. Use of non-reimbursable devices was reported by 21.6%. The mean annual cost of informal caregiving, including activities by professional staff, was €1,328.7 (US$1,510.46). Use of assistive devices added an additional €736.6 (US$ 837.37) yearly. “MS is responsible for a substantial economic burden due to indirect and informal care costs, even in a population with low physical disability,” the researchers said. “Effective therapeutic interventions to improve the management of early symptoms as well as implementing workplace strategies focused on job retention may be essential to decrease the high economic burden of MS,” they concluded.

The first patient has been dosed in a Phase 2B clinical trial evaluating the safety, efficacy, and tolerability of SAR442168 in people with relapsing multiple sclerosis (MS). SAR442168, formerly known as PRN2246, is being developed by Principia Biopharma, in collaboration with Sanofi Genzyme, for MS and other central nervous…

In clinical practice, relapse events dropped by roughly half over a four-year period in relapsing-remitting multiple sclerosis (RRMS) patients treated with Aubagio (teriflunomide), a real-world study reports. The study, “Real-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study,” also examined patients’ perspectives in…

The U.S. Food and Drug Administration (FDA) has warned against the use of plasma transfusions from young donors to alleviate or treat the symptoms of multiple sclerosis or other diseases, noting such transfusions have no proven clinical benefit and carry known health risks associated with their use. Plasma is the liquid component of blood, containing proteins that help in clotting, and can be used to treat bleeding disorders and cases of trauma. But its use in transfusions as a means of treating conditions ranging from multiple sclerosis, dementia, Alzheimer’s, Parkinson’s, heart disease and post-traumatic stress disorder are of concern, the FDA said in issuing its statement of Feb 19. "We have significant public health concerns about the promotion and use of plasma for these purposes," the FDA statement reads. "[W]e’re alerting consumers and health care providers that treatments using plasma from young donors have not gone through the rigorous testing … [necessary] to confirm the therapeutic benefit of a product and to ensure its safety." Scott Gottlieb, the FDA's commissioner, and Peter Marks, director of its Center for Biologics Evaluation and Research, jointly issued the statement cautioning healthcare providers and the public that plasma infusions — being done at "a growing number of clinics" in several U.S. states — are not an FDA-approved or recognized treatment for aging, memory loss, multiple sclerosis, or other diseases. FDA-approved treatments largely come through clinical trials overseen by researchers and independent boards, and performed under an investigational new drug (IND) application that helps to ensure patient safety. “Our concerns regarding treatments using plasma from young donors are heightened by the fact that there is no compelling clinical evidence on its efficacy, nor is there information on appropriate dosing for treatment of the conditions for which these products are being advertised,” the statement notes. According to the FDA, large volumes of plasma might be also be needed for such transfusions and that volume can pose significant risks, including allergic reactions, infections, and heart and respiratory problems. The agency also expressed concern that such transfusions could discourage patients from taking medications or other treatments known to be safe and effective for their condition. According to the agency, some "establishments" across the country are recommending young donor plasma infusions and "touting" them "as cures and remedies," while sometimes "charging thousands of dollars." The FDA advises patients to consult with their treating physician before opting for any treatment to confirm that it is approved for use, meaning its safety and effectiveness have been demonstrated. “Simply put, we’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors,” the FDA statement reads. It also asks that patients who have undergone a plasma transfusion report any ill effects to its MedWatch program, which tracks adverse events related to treatments.

A collaborative initiative between Lyfebulb and Celgene — called “Addressing Unmet Needs in MS: An Innovation Challenge” — is inviting applications from U.S.-based entrepreneurs who have multiple sclerosis (MS), or who have been affected by the disease, and whose companies are trying to find solutions to address unmet needs…

Lowering body temperature helps to improve exercise and functional capability in multiple sclerosis (MS) patients by preventing disease worsening, researchers in  Greece report. The study with that finding, “Impact of pre-cooling therapy on the physical performance and functional capacity of multiple sclerosis patients: A systematic review,” was published in…

Lyfebulb announced that it has joined with Celgene in launching an innovation challenge for entrepreneurs with or impacted by multiple sclerosis (MS) to develop user-driven solutions that might make daily life a little easier for patients. The initiative, “Addressing Unmet Needs in MS: An Innovation Challenge,” will be…

A final and weighty opinion regarding whether Ocrevus (ocrelizumab) will be among treatments available at low or no cost to primary progressive multiple sclerosis (PPMS) patients in England and Wales — through the National Health Service (NHS) — has been put on hold, according to the Multiple Sclerosis Trust. The…

A new medical cannabis company called Katexco Pharmaceuticals aims to develop oral therapies that harness the brain’s endocannabinoid and nicotine receptors to treat inflammatory diseases such as multiple sclerosis. Co-founded by two Stanford University researchers — Jonathan Rothbard, PhD, and Lawrence Steinman, MD — Katexco will leverage their expertise…

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…

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…

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…

Therapy candidates that block enzymes responsible for making cholesterol can promote myelin regeneration, a discovery that could lead to new regenerative medicines capable of treating multiple sclerosis (MS) and other neurological diseases, according to a study. In fact, Convelo Therapeutics plans to do just that, announcing its intention to use…

In women with relapsing-remitting multiple sclerosis (RRMS), there is a significant increase in brain lesion volume after pregnancy, but it is not accompanied by a loss of brain cells, a study suggests. Conducted by researchers at Harvard Medical School, the study, “Quantitative MRI analysis of cerebral lesions and…

Many patients report a history of other conditions such as migraine headaches, irritable bowel syndrome, fibromyalgia, and mood and anxiety disorders, before being diagnosed with multiple sclerosis (MS). According to a new study, these symptoms could be warning signs of MS and help in its early detection. “Prodrome” is a…

A significant number of multiple sclerosis patients show signs not only of depression and anxiety, but also of alexithymia — an inability to describe or process emotional responses, a research group in Brazil reported. The study, “High levels of alexithymia in patients with multiple sclerosis,” published in the…

Cognitive impairment is common among patients with multiple sclerosis (MS) and can be assessed through touchscreen cognitive tests in clinical care, a British study reports. The study “Investigating Domain-Specific Cognitive Impairment Among Patients With Multiple Sclerosis Using Touchscreen Cognitive Testing in Routine Clinical Care” was published in the…

The National Institute for Health and Care Excellence, known as NICE, has decided against recommending that Ocrevus be part of public-funded treatments for adults with primary progressive multiple sclerosis (PPMS). The National Health Service (NHS) is the subsidized, publicly funded healthcare system for England, with similar structures…

Researchers confirmed that Sativex spray is beneficial in alleviating pain in patients with multiple sclerosis (MS), and also improved their pain sensitivity to cold temperatures. The study reporting the findings, “Pain Modulation after Oromucosal Cannabinoid Spray (SATIVEX) in Patients with Multiple Sclerosis: A Study with Quantitative…

Treating mice in a model of multiple sclerosis (MS) with laquinimod before the onset of symptoms eased inflammation so as to help preserve their vision — lessening damage to the optic nerve and retina, a study from Germany reports. The study, “Laquinimod protects the optic nerve and…

A first patient has been enrolled in a single-site trial to evaluate the potential of electrical stimulation, called  Electroceutical Therapy, in reducing brain injury, Endonovo Therapeutics, the therapy’s developer, announced. Electroceutical Therapy is a non-invasive and wearable electronic device that uses pulsed electromagnetic fields (PEMF) to stimulate the central nervous system.

Axim Biotech announced that its way of extracting and purifying THC (delta-9-tetrahydrocannabinol) — an active compound in medical cannabis — has been approved to receive a patent. The notice of allowance for patient No. 15/146668 came in letter from the United States Patent and Trademark Office (USPTO), Axim said in…

A new clinical trial will be the first in the world to recognize the importance of retaining hand function for wheelchair-bound patients with primary progressive MS (PPMS), according to a press release from Queen Mary University of London. The international trial, which will be conducted by a…

Young adults at age 20 who are obese and smoke are not only at a higher risk of developing relapsing multiple sclerosis — those who become MS patients after age 20 are also more likely to advance to secondary progressive MS more quickly, researchers in Sweden report. But the link…

Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are equally effective as first-line treatments in people with relapsing-remitting multiple sclerosis (RRMS), but Gilenya may be of slightly more benefit to those who switch from a previous injectable therapy, according to a real-world study of patients in Italy. The study, “…

Young adults with multiple sclerosis (MS) have higher relapse rates and respond better to Gilenya treatment compared to the overall MS population, data from a post hoc analysis of three separate trials show. The study, “Relapse Rate and MRI Activity in Young Adult Patients With Multiple…