News

TG Therapeutics and the U.S. Food and Drug Administration (FDA) have agreed on a special protocol assessment for a Phase 3 trial program evaluating TG-1101 (ublituximab) to potentially treat relapsing forms of multiple sclerosis (MS). A special protocol assessment (SPA) is a procedure by which the agency officially evaluates the…

For the first time, scientists have shown they can correct gene mutations in human embryos — a breakthrough with implications for multiple sclerosis (MS) and several other diseases. This landmark study was a collaboration involving scientists at the Salk Institute in La Jolla, California; the Oregon Health & Science University in…

Myobuddy Products has enlisted a rising fitness star to help it publicize its new Myobuddy Massager Pro, a massaging device that can help anyone from an elite athlete to a person with a muscle condition such as multiple sclerosis. Dakota Rager, who qualified for the national Reebok CrossFit Games competition, is a former Army diver who beat out more than 200,000 men in several regional competitions this year. CrossFit is a workout regimen aimed at improving the body's normal functional movements. The Massager Pro takes a multi-pronged massaging approach, including vibration, heat and percussion therapy, or applying tension to the body. The device's benefits including soothing sore muscles and helping relax tight fascia, or connective tissue surrounding muscles. Myobuddy started an MS Support Program in May to encourage MS patients to try massage therapy and to advance research on the approach. The company said some MS patients report that the Massage Pro helps them sleep better by alleviating their restless leg syndrome. They also report that it relieves muscle tension and fatigue, it added. Myobuddy's website includes information on how to use the Massage Pro for any muscle group. Those with questions can get answers by emailing [email protected] or calling (844) 696-2833. Rager (@ragerdakota), who at 5’4’’ and 169 lbs. is built like a fireplug, said he uses everything he can to give him an edge in competitions. If a massage therapy device is powerful enough to help MS patients, then it can help him, too, he has decided. "I really love the Myobuddy Massager, and have been using it throughout my training," he said in a press release. "It has the perfect combination of vibration and power and really goes deep to soothe my sore muscles and relax my tight ones after rigorous workouts. I highly recommend it for anyone who wants their muscles to feel and perform their very best." At only 25, Rager is already ranked as one of the top 100 CrossFit competitors worldwide. He was just one of 40 men to participate in the Reebok CrossFit Games in Madison, Wisconsin, Aug. 3-6. "We've had a lot of highly influential people in the sports and fitness world deliver organic endorsements for the Myobuddy, and we're extremely grateful for that," said Lillo Furca, Myobuddy's founder and CEO. "We've spent so much time and energy perfecting our massager to ensure that it delivers optimal results. The testimonies are a testament to our team and to our product." The company loves to "hear about how we're helping people who put their bodies in extreme situations on a regular basis," he added.

An exoskeleton developed by Harvard University researchers could restore multiple sclerosis patients’ balance and some of their walking capability, according to a study. ReWalk Robotics is moving toward commercializing the system, developed at Harvard’s Wyss Institute for Biologically Inspired Engineering. In addition to MS patients, the exosuit should help people with Parkinson’s and other neurodegenerative conditions,…

Two compounds found in sunscreens suppressed multiple sclerosis symptoms in mice, a study shows. The substances, known as salate derivatives, belong to a class of compounds called nonsteroidal anti-inflammatory drugs. Evidence from the 1970s suggested that higher vitamin D levels from getting more sunlight could reduce the rate of MS. Subsequent studies indicated this was unlikely, however. Researchers who noticed that ultraviolet light suppresses MS in mice hypothesized that this could be the reason for the reduced prevalence of the disease in tropical areas. University of Wisconsin researchers wondered if sunscreen would prevent ultraviolet light from suppressing MS in mice. The team, led by Dr. Hector F. DeLuca, an emeritus professor in the university's Department of Biochemistry, chose six commercially available sunscreens, then exposed the mice to UV radiation. Confirming previous findings, they observed that UV radiation decreased the severity of MS. But, unexpectedly, they discovered that when mice were not receiving ultraviolet light, some of the sunblocks suppressed their MS for up to 30 days anyway. An analysis revealed that the salate derivatives homosalate and octisalate were the sunscreen components responsible for suppressing MS. The two are esters of salicylic acid, a common medication for acne, psoriasis, warts, and dandruff. Further analysis showed that homosalate was able to suppress MS by itself, but octisalate needed to be combined with homosalate to achieve significant results. The team also discovered that the salates' effectiveness depended on the dose. The more that homosalate was applied, the better the result, they said. The only adverse effect of homosalate and octisalate was temporary skin irritation. The study indicated that salate esters' ability to suppress MS is not due to their sunblocking ability per se, because some of the sunscreen brands that did a good job of blocking sunlight did not suppress the disease. Salate derivatives are well-known inhibitors of the enzyme cyclooxygenase, or COX. Because COX-2 has been found in MS lesions, salate derivatives might improve MS by suppressing COX, the researchers said. Overall, “salates may be useful in stopping the progression of MS, and may provide new insight into mechanisms of controlling autoimmune disease,” the researchers concluded.

The Consortium of Multiple Sclerosis Centers (CMSC) will form a new Physician Assistant Special Interest Group to provide physician assistants (PAs) with a specialized forum to exchange ideas and information on multiple sclerosis (MS) patient care. CMSC is an educational, training, and networking organization for MS healthcare professionals…

Resistance training like weight lifting can protect or even regenerate the nerve cells of relapsing-remitting multiple sclerosis patients, slowing the progression of the disease, according to a clinical trial. A hallmark of MS is the brain shrinking faster than normal, and findings from this trial indicates that resistance training can slow the shrinking or even make some brain areas grow. Research has shown that physical training benefits MS patients, helping them alleviate many symptoms, including excessive fatigue and balance control problems. Recent studies suggest that exercise can have a disease-modifying role in MS. This means physical activity can be an important adjuvant, or add-on therapy, for standard-of-care regimens. Researchers followed 35 patients with relapsing-remitting MS for 24 weeks. Eighteen patients did resistance training twice a week, consisting of four lower- and two upper-body exercises. The other 17 patients struck with their normal routines. Before and after the 24 weeks, doctors took magnetic resonance imaging scans, or MRIs, to evaluate patients' brain structures. After the 24 weeks, the scans showed less brain shrinkage in those who had resistance training. Some of their cortical brain regions were also thicker — an indication they were growing. It is not clear why exercise benefits MS patients' brains, nor if exercise has the same effect on all patients. Additional studies are needed to clarify its therapeutic effect, the researchers said. That knowledge could help improve current MS therapies.

The MyoPro electric arm, which uses motors to help multiple sclerosis patients move weakened arms and hands, has obtained a quality designation required for selling medical equipment in Europe. Myomo‘s powered brace, which also helps people with spinal cord and nerve injuries, received what the European Union calls CE Mark certification. The company…

Twenty-four people have now received the multiple sclerosis and psoriasis therapy KY1005 in a Phase 1 clinical trial, according to its developer, Kymab. The Cambridge, England, company creates human antibody drugs for autoimmune diseases. The trial will focus on KY1005 as a psoriasis therapy, although its mechanism of action should work…

Long-term Tysabri (natalizumab) treatment of relapsing multiple sclerosis (RMS) improves physical and mental health and leads to greater satisfaction with therapy, new research shows. The study, ”Long-term natalizumab treatment is associated with sustained improvements in quality of life in patients with multiple sclerosis,” appeared in the journal…

Abarca Health has signed a value-based reimbursement contract with Biogen for select products in its multiple sclerosis (MS) portfolio. This is the first time such an agreement applies outcomes-based contracts to cover Medicaid patients in the United States. The deal offers a novel approach to connecting outcomes with the…

The U.S. Food and Drug Administration (FDA) has approved the marketing of Cognigram, a medical device developed by the cognitive science company Cogstate to evaluate a patient’s cognitive health. This device may be a…

Multiple sclerosis (MS) patients in the first year of diagnosis frequently suffer from depression, pre-morbid personality, self-perception issues and other psychological problems, an Italian study finds. Yet it is hard to predict the degree of symptoms since MS takes a different course in each individual. The study, “The first year after…

Five clinics in the Washington area that specialize in administering intravenous and injected treatments to people with chronic diseases are now offering the new multiple sclerosis therapy Ocrevus (ocrelizumab). Arise Infusion Therapy Services said its staff is helping patients manage the authorization process that many insurers require before agreeing to cover…

A group of experts recently concluded that clinical trials are the best way to explore whether cell-based therapies are viable options for treating multiple sclerosis. In a newly published article, MS researchers reviewed evidence on a range of cell therapies, including stem cell transplants and delivery or stimulation of various cell types. Clinical trials, the panel argued, would be the optimal way to examine which types of cells should be used, how they should be delivered, and the types and disease stages the treatments are suitable for. The article focused on four types of cell-based treatments: autologous stem cell transplants, mesenchymal and related stem cell transplants, use of drugs to manipulate stem cells in the body to boost their ability to repair, and transplants of oligodendrocyte progenitor cells to trigger new myelin production. Loss of the myelin that protects neurons is a hallmark of MS. Such treatments hold promise to attain what current disease-modifying therapies in MS have not: halting the disease without lifelong treatment that has potential side effects, and regenerating damaged tissue. In addition to reviewing the evidence surrounding cell-based treatments, the expert group focused on the availability of the treatment options outside of controlled trials. “Media attention has resulted in some cases of misrepresentation and exaggeration of therapeutic claims for cell-based therapies for multiple sclerosis and other diseases,” the team wrote. This has caused patients to seek the treatments — paying out-of-pocket — at unregulated clinics. The panel noted that several drugs in development, including opicinumab, are aimed at promoting remyelination. In addition, drugs that are already approved for other conditions might have remyelinating properties, and might be repurposed to treat MS. Although studies are ongoing, the panel noted that it is unclear if the drugs do promote remyelination. Despite ongoing research and — in some cases — clinical use of cell-based therapies for MS, these treatments should be considered experimental, the expert group concluded. They again underscored the importance of clinical trials in providing a controlled environment for patients wishing to have cell therapy, as well as a source of evidence for the feasibility of these approaches.

The neurotransmitter glutamate triggers most brain signals by activating proteins on the surface of neurons called glutamate receptors. Columbia University Medical Center researchers have taken the first 3D images of the AMPA-subtype glutamate receptors involved in several brain activities, including memory and learning. By increasing scientists' understanding of how the receptors work, the images could offer insight into the role that faulty receptors play in the development of neurodegenerative disorders such as multiple sclerosis, Alzheimer’s, and Parkinson’s. And that insight could lead to therapies. “With our new findings, we can now, for the first time, visualize how the neurotransmitter glutamate opens glutamate receptor ion channels,” Dr. Alexander Sobolevsky, an associate professor of biochemistry and molecular biophysics at Columbia, said in a news release. “This is the fundamental process that directly affects learning and memory, and finding its structural determinants has been the primary goal of molecular neuroscience since the ‘90s," added Sobolevsky, the senior author of the study. For the brain to work properly, neurons need to communicate with each other. To do that, they use neurotransmitters, small compounds that pass from one cell to a receptor on another cell. Glutamate is the neurotransmitter involved in many of these communications, and glutamate receptors are the structures that gather up many of the signals. Several types of glutamate receptors participate in cognitive functions. AMPA receptors – a subgroup of glutamate receptors – are known for their fast activity, opening and closing in less than a millisecond. Because they work so fast, they are involved in rapid brain responses, such as rapid perception and reaction to the surrounding environment. For years, researchers have tried to understand how AMPA receptors work. In previous studies, Sobolevsky's team learned how the receptors regulated both the speed and strength of cell communications. In the recent study, the researchers used advanced imaging techniques developed by Dr. Joachim Frank to record the actions of the AMPA receptors. Frank, a professor of biochemistry and molecular biophysics, and biological sciences, was a co-author of the study. The images showed that AMPA receptors open in the presence of glutamate or a similar signaling compound. The mechanism can be compared to a camera’s iris, or aperture. The signaling particles pass through the opening, triggering electrical signals necessary for brain activity. “These new fundamental discoveries have implications for our understanding of neurotransmission by glutamate, our brain’s major neurotransmitter,” said Edward C. Twomey, a Ph.D. candidate who was the first author of the study. “Understanding these processes will impact future studies on glutamate receptor signaling in neurodegenerative diseases as well as drug design.”

Kezar Life Sciences announced that it is planning to move ahead with clinical testing of KZR-616, a potential treatment for multiple sclerosis (MS) and other autoimmune diseases and inflammatory disorders. The company recently concluded a Phase 1 safety study of the treatment, and raised $50 million in investment funding to support its development. KZR-616 is a first-in-class selective immunoproteasome inhibitor, meaning it works by blocking abnormal protein degradation. Cells eliminate proteins by sending them to a specialized cell compartment known as the proteasome. In immune cells, the proteasome is called immunoproteasome, and it regulates several selective inhibitors and participates in the regulation of the immune response associated with inflammatory diseases such as MS, rheumatoid arthritis, Crohn's disease, and lupus. "We are pleased with the results of our healthy volunteer study, and grateful for the support of such an excellent group of investors to finance our upcoming clinical trials," John Fowler, Kezar Life Sciences’ CEO, said in a news release. "The strong demand for this financing reflects growing excitement for the potential of immunoproteasome inhibition in treating autoimmune disorders and recognizes the clear leadership position enjoyed by Kezar." The Phase 1 trial enrolled 82 healthy subjects, who were assigned to receive either KZR-616 or placebo. In total, 61 volunteers were given KZR-616 as single or multiple doses at varying dose levels to identify the optimal dose for both tolerability and proteasome inhibition. Results will be presented at the American College of Rheumatology's Annual Meeting to be held in San Diego in November. "These initial clinical trial results demonstrate that KZR-616 is achieving the desired levels of immunoproteasome inhibition that correlate with anti-inflammatory activity seen in laboratory models,” said Christopher Kirk, PhD, company president and CSO. “By selectively targeting the immunoproteasome, we believe we can avoid the toxicities associated with dual proteasome inhibitors like Velcade and Kyprolis." The Series B financing round was led by Cormorant Asset Management and Morningside Venture and raised $50 million to support the development of KZR-616. Kezar announced it has the support of new investors, including Cowen Healthcare Investments, Pappas Ventures, Qiming Venture Partners, and Bay City Capital. "Cormorant is pleased to support Kezar as it enters an exciting series of patient studies, the first ever with a selective immunoproteasome inhibitor," said Bihua Chen, founder of Cormorant Asset Management. "While much work remains, I believe KZR-616 has the potential to be a transformative treatment in autoimmunity."

A cell therapy intended to boost myelin regeneration — Q-Cells by Q Therapeutics — has received a green light from the U.S. Food and Drug Administration to proceed with a clinical trial in patients with transverse myelitis (TM), a disease that like multiple sclerosis is characterized by myelin damage. FDA approval of the company’s Investigational New…

Canadian oilman Hank Swartout made a fortune as longtime founder and CEO of Precision Drilling. The Calgary native mortgaged his house to start the company, which by the time he left in 2009 had annual sales of $7 billion. But an early diagnosis of multiple sclerosis (MS) at the age…

Eli Lilly and Nektar Therapeutics have established a development and commercial agreement for the investigational T-cell stimulator therapy NKTR-358 for the treatment of autoimmune disorders, including multiple sclerosis. NKTR-358, discovered and initially developed by Nektar, has the potential to modulate immune system responses to re-establish an immune balance in patients with autoimmune disorders. The treatment targets the interleukin 2 receptor complex (IL-2R) that is expressed on the surface of a subset of immune cells called regulatory T-cells, or Tregs. NKTR-358 activity stimulates the proliferation of Tregs, which in turn will regulate the activity of other immune cells that are uncontrolled and are responsible for the underlying mechanisms of autoimmune disorders. "We look forward to working with Nektar to study this novel approach to treating a number of autoimmune conditions," Thomas F. Bumol, PhD, senior vice president of biotechnology and immunology research at Eli Lilly, said in a press release. "NKTR-358 is an exciting addition to our immunology portfolio and reinforces Lilly's commitment to sustain a flow of innovative medicines in our pipeline." Bumol added. Under the agreement, Lilly and Nektar will continue to jointly develop NKTR-358. Nektar will be responsible for completing the ongoing Phase 1 clinical study; and Phase 2 clinical development costs will be shared by the two companies, with Lilly covering 75 percent of the costs and Nektar the remaining 25 percent. Nektar will have the option to take part of the Phase 3 development of NKTR-358 on an indication-by-indication basis. "We are very pleased to enter into this collaboration with Lilly as they have strong expertise in immunology and a successful track record in bringing novel therapies to market," said Howard W. Robin, president and CEO of Nektar. "Importantly, this agreement enables the broad development of NKTR-358 in multiple autoimmune conditions in order to achieve its full potential as a first-in-class resolution therapeutic." Based on the announced agreement, Lilly will pay an initial amount of $150 million to Nektar, which will also be eligible to receive up to $250 million from additional development and regulatory milestones. In the future, Nektar may also receive royalties from the product depending on its investment in NKTR-358’s Phase 3 development and future product sales. Lilly will cover all costs of global marketing of NKTR-358, and Nektar will have an option to co-promote the drug in the United States.

A new analysis of Phase 2 clinical data on Innate Immunotherapeutics’ investigational drug MIS416 to treat secondary progressive multiple sclerosis has confirmed that the drug failed to improve neuromuscular function or patient reported outcomes. The initial evaluation of data obtained from the one-year trial, announced in June, showed disappointing results. These results, gleaned from 70 patients who were randomly designated to receive either weekly injections of MIS416 or a placebo control, failed to demonstrate significant differences or clinically meaningful improvements in patients treated with MIS416 compared to those in the control group. After this initial setback, the Australian company sponsored an additional analysis of the trial results to identify any potential subgroup of clinical responders that could benefit from MIS416 and who might have been masked in the first population-based analysis. However, this post-hoc analysis also failed to show any positive effects of MIS416. Although the detailed report of this second analysis has not yet been released, the Sydney-based company conceded that the final outcome will not change. "All previous reports of MIS416 making a meaningful difference in the lives of many patients must either be dismissed as a very robust placebo effect or the trial failure is attributable to some other reason. It is my view that there may be other reasons," Innate CEO Simon Wilkinson said in a press release. "Patients with SPMS have a complex mix of symptoms and their disease can't be monitored by a simple blood test or MRI scan," he added. "We used the best assessment tools available as recommended by expert practitioners in MS, but we suspect they weren't sensitive enough to pick up the small but potentially significant changes that can lead to a substantial impact on patients' activities of daily living and quality of life." The lack of efficacy of MIS416 shown by the trial results is inconsistent with previous clinical experience, and the benefits reported by those receiving MIS416 for the past eight years.

A new study draws a reverse link between the number of MRI scans of multiple sclerosis patients who are on interferon-beta 1a and doctors declaring there is evidence of the patients’ disease worsening. When doctors looked at one scan, rather than multiple ones, they were more likely to say that…

According to a study by researchers at Cleveland's Case Western Reserve University School of Medicine, pre-existing inflammatory diseases affecting the central nervous system make mesenchymal stem cells less effective in treating multiple sclerosis. The study notes that MSCs potentially produce several signaling proteins that can regulate immune system responses as well as help tissue regenerate. Preclinical studies have shown that this can reduce brain inflammation while improving neural repair in animal models of experimental autoimmune encephalomyelitis -- an animal version of MS that is often used in laboratory studies, since it resembles the inflammation and neuronal damage seen in MS patients. Given the need for effective new MS therapies, the results will help MSCs to advance to human clinical trials. So far, results have reported good safety data, though such therapies have failed to demonstrate therapeutic efficacy. Most such trials so far have used stem cells collected from the patient, a process known as autologous transplantation — yet this may explain why MSCs have not been effective. It's possible that pre-existing neurological conditions may alter stem cells' responsiveness as well as their therapeutic activity. To see whether that is in fact the case, team members collected stem cells from the bone marrow of EAE mice. But these stem cells were unable to improve EAE symptoms, whereas stem cells collected from healthy mice retained all their therapeutic potential and improved EAE symptoms. A more detailed analysis showed that the MSCs derived from EAE animals had different features than their healthy counterparts. In addition, the team confirmed that MSCs collected from MS patients were also less effective in treating EAE animals, compared to MSCs from healthy controls. Indeed, these MSCs from patients produced pro-inflammatory signals instead of the protective anti-inflammatory ones. “Diseases like EAE and MS diminish the therapeutic functionality of bone marrow MSCs, prompting re- evaluation about the ongoing use of autologous MSCs as a treatment for MS,” the team wrote, adding that its study supports the advancement of MSC therapy from donors rather than autologous MSC therapy to treat MS while raising "important concerns over the efficacy of using autologous bone marrow MSCs in clinical trials."

Christine Sinclair, captain of Canadian women’s soccer teams that won two Olympic bronze medals, has joined the fight against multiple sclerosis by supporting A&W’s Burgers to Beat MS campaign. The Multiple Sclerosis Society of Canada said Sinclair will visit A&W restaurants across Canada on Aug. 23 and 24 to raise funds and awareness of MS. Sinclair is close to the cause because her mother, Sandi, who coached her soccer teams when Christine was a child, has the disease. Sandi is one of about 100,000 people with MS in Canada, which has the highest rate of the disease in the world. "I have become a part of this to educate the public and support finding a cure," Sinclair said in a press release. "I don't want other people to go through what my family has gone through, with the difficulties my mom faces every day." Sandi Sinclair now lives in a long-term care facility. Christine decided to help the MS Society of Canada after her mother's mobility become more and more limited, and she finally ended up in a wheelchair. "Each year we look forward to our partnership with A&W," said Valerie Hussey, chair of the MS Society of Canada's board of directors. "We are excited to have Christine, a Canadian icon, share her personal connection to MS and help raise awareness for our cause." Burgers to Beat MS, now in its ninth year, has raised nearly $10 million for the cause. It is the country's largest annual fundraiser benefiting the MS Society of Canada. From this week on, about 900 A&W restaurants nationwide will be helping the society raise funds. Supporters will be able to donate by rounding up their bill at the register, by buying $1, $2 or $5 paper cutouts, or by dropping cash in donation mugs. Supporters will also be able to contribute online. The campaign will end with a special day on Thursday, Aug. 24, when those who run the restaurants double every donation made from the sale of Teen Burgers. This means the donation on each burger will go from $1 to $2.

A new study reports that vitamin D supplements do not prevent bone loss in multiple sclerosis patients who are not vitamin-D-deficient. Previous research has suggested that low levels of vitamin D increase the risk of a person developing MS. In addition, Vitamin D prevents loss of bone density. That loss can lead to fractures and osteoporosis, a condition that many MS patients experience as their disease progresses. Researchers decided to investigate the effect of weekly doses of vitamin D3 on patients with relapsing-remitting multiple sclerosis, versus patients receiving a placebo. All 68 participants in the Phase 4 clinical trial also received 500 mg a day of calcium, a compound that is also important for bone health. The team measured the effectiveness of the supplemental vitamin D by analyzing biomarkers of bone health in blood. These included levels of the proteins PINP, or procollagen type I N propeptide, and CTX1, or C-terminal cross-linking telopeptide. At the start of the study, levels of PINP and CTX1 were not significantly different between the two groups. And that continued to be true at week 48 and week 96 of the study. The bottom line was that vitamin D supplementation did not change bone health in patients with MS after 96 weeks. “Our results do not support that high dose weekly vitamin D supplementation is beneficial for bone health in ambulatory persons with MS, and suggest that weekly vitamin D supplementation alone is not sufficient to prevent bone loss in persons with MS who are not vitamin D deficient,” the researchers concluded. The results were different from previous studies supporting the beneficial effects of vitamin D supplementation in MS patients. The researchers said they believed the discrepancy was due to differences in the studies' patient characteristics, sample size, and duration of follow-up.

Ocrevus' market introduction is off to a stellar start, with nearly half of neurologists surveyed by Spherix Global Insights saying they are using the therapy — the first ever approved for both relapsing and primary progressive multiple sclerosis. Within six months, 80 percent of neurologists are expected to prescribe Ocrevus, according to a report in the second-quarter edition of RealTime Dynamix: Multiple Sclerosis by Spherix Global Insights. But insurance is having an increasing impact on treatment decisions, the report also found, according to a Spherix press release. More patients are receiving less than optimal care because of inadequate or inferior insurance coverage, and neurologists report that insurers have become more aggressive in managing MS patients. Surveying 104 neurologists in June, the report showed that physicians followed through with their intent — reported in earlier surveys — to prescribe Ocrevus as it became available. With Ocrevus being the first approved drug for primary progressive MS, these patients make up a sizable part of those receiving it. But patients with relapsing forms of MS represent more than half of new users, according to the report. Ocrevus was also, by far, the drug that neurologists had learned most about, and felt most excited about using, the report added. Most of the patients on Ocrevus were switched from Biogen's Tysabri or Rituxan — a drug that, like Ocrevus, is also produced by Genentech/Roche. One in five patients was switched from an oral disease-modifying treatment, mainly Biogen’s Tecfidera (dimethyl fumarate). But for about 25 percent of Ocrevus-treated patients, the drug is the first disease-modifying therapy they have received. The survey also revealed that patients are the driving force behind new Ocrevus prescriptions. Seventy-one percent of neurologists receive requests from patients who want to start the treatment. While neurologists have to turn some of these requests down for various reasons, a large proportion of those who ask for the treatment receive it. Another insight from Spherix’s “RealWorld Dynamix: DMT Brand Switching in MS” survey was that patients' requests for a specific brand are often honored. Seventy-seven percent were prescribed the brand they requested, the survey showed. Interestingly, neurologists believed the number to be lower. Most patients who made a specific request, the report indicated, asked for Tecfidera in the past year and a half. Tecfidera is by far the leading oral disease-modifying drug prescribed in MS. Meanwhile, according to the report, Biogen's Avonex, Bayer's Betaseron, Teva's Copaxone, and EMD Serono's Rebif continue on a downward path. At least 30 percent of neurologists report lower use of these therapies in the past three months. Patients previously on these drugs are mainly switched to oral disease-modifying drugs. But this trend is projected to slow, with only Sanofi-Genzyme's oral Aubagio (teriflunomide) continuing to grow. But the choice of treatment may increasingly be driven by insurance. Compared with the same quarter of 2016 — when neurologists estimated that 14 percent of patients received suboptimal treatment because of poor insurance coverage — 20 percent of patients are now judged to be in this situation. Also, 60 percent of surveyed physicians feel that insurance companies have become more aggressive in MS treatment management. A similar percentage also say that insurance policies influence how they prescribe specific disease-modifying drugs.

Fatigue, limited mobility, and poor self-esteem or resiliency were found to be associated with periods of serious depression among multiple sclerosis patients, according to a recent study. Previous research has suggested that MS patients are at risk of major depression, with potentially profound impact on their quality of life. But only a few studies have addressed the incidence of depression among MS patients or the risk factors that may underlie its occurrence. Researchers in Canada enrolled 188 MS patients being treated an Alberta clinic, who were interviewed to assess potential risk factors for depression: namely, socioeconomic status, disease-related factors, childhood risk factors, psychosocial factors, and health behaviors. Participants were also asked to complete the Patient Health Questionnaire every two weeks for six months to identify depressive symptoms in real-time. Over a six-month follow-up, 36 cases of depression were reported among the group of MS patients analyzed. The incidence of depression was 0.019 for women, but higher — 0.044 — for men. Importantly, several factors seemed to be associated with depression in these patients — fatigue, limited mobility, and low resiliency, self-esteem, and self-efficacy, as well as poor coping skills. Results also showed that gender and income were associated with depression. Overall, the researchers concluded that "depression in MS exhibits a risk factor profile similar to that of depression in the general population, with the additional impact of MS illness-related factors. Potentially modifiable risk factors, such as coping with stress and resiliency, present opportunities for focus of further research in depression in MS treatment and prevention efforts." Concerning treatment, the team also emphasized that "while there is evidence in the clinical context that supports the efficacy for pharmacologic and non-pharmacologic treatments for depression in the general population, there is currently insufficient evidence to support/or refute the efficacy of depression treatment for individuals with MS ... Clearly this is an area that requires additional research."

Costs associated with multiple sclerosis increase as the disease worsens, according to a study of more than 16,000 patients in 16 European countries. The study, “New insights into the burden and costs of multiple sclerosis in Europe,” was published in the Multiple Sclerosis Journal. Researchers obtained their information from patient self-reporting. Patients used the Kurtzke's Expanded Disability Status Scale (EDSS) to assess the severity of their disease. They also reported on their quality of life and their resource use. Patients were divided into three categories. Those with a score between 0 and 3 on the EDSS scale were deemed to have a mild disease. The disease of those with scores of 4 to 6.5 was considered moderate. And the disease of those with scores of 7 to 9 was classified as severe. Patients assessed their health-related quality of life with the EuroQol Five Dimensions questionnaire. The average age of the 16,808 participants was 51 and a half years old. The work capacity of MS patients dropped from 82 percent of a healthy person's to 8 percent as the severity of the disease increased, researchers said. Patients' quality of life scores were about the same as those seen in the general population when they had a mild disease. But they plunged to less than zero when their disease became severe. The mean annual cost of having a mild form of MS was 22,800 euros, or around $26,300, researchers reported. The cost of having a moderate disease was 37,100 euros, or about $42,800. And the cost of a severe disease was 57,500 euros, or $66,340. Healthcare accounted for 68 percent of total costs with a mild disease, 47 percent with a moderate disease, and 26 percent for a severe disease. "Costs are dependent on the availability, use and price of services and on disease severity," the researchers wrote. "Costs were related to disease severity" in all countries "and were dominated by production losses, non-healthcare costs and DMTs," or disease-modifying therapies. Those therapies may be a key reason why the highest percentage of healthcare costs occurred in patients with a mild disease, researchers said. Doctors prescribe a lot of DMTs to this group. Other factors related to the high percentage were that many patients with mild diseases are still able to work -- meaning they incur fewer production-loss costs -- and this group requires fewer community services. As MS becomes more severe, patients' production losses rise, and they use more community services. "The intensity of healthcare service use varied widely across the countries," researchers wrote. "This reflects differences in healthcare organization, medical traditions, ease of access and – most importantly – availability of given services." Researchers also assessed patients' levels of fatigue and cognitive difficulties. Ninety-five percent reported fatigue, and 71 percent cognitive difficulties. Fatigue and cognitive difficulties had significant impacts on quality of life scores, researchers said.

GeneFo, an online multiple sclerosis (MS) community that offers support, advice and educational resources to patients, will conduct a free webinar July 26 for those interested in knowing more about how MS affects sex and intimacy. The webinar, hosted by renowned MS expert Dr. Tuppy Owens, follows a GeneFo survey showing that sex…

Australia has become the first country to approve Genentech's Ocrevus for relapsing and primary progressive multiple sclerosis treatment since the therapy's initial approval by the U.S. Food and Drug Administration in March 2017. The Australian Therapeutic Goods Administration gave Ocrevus the green light on July 17, filling an unmet need for Australia's estimated 23,000 MS patients. “We are pleased that another regulatory body recognized for its rigorous review process has approved Ocrevus with a broad label as a new treatment option for people with relapsing or primary progressive MS in Australia,” Dr. Sandra Horning, Roche’s chief medical officer and head of global product cevelopment, said in a press release. “Approval in Australia is significant because of the high prevalence of MS in the country, making it the leading cause of non-traumatic disability in young adults." The drug's developer, Genentech, and Genentech's parent company Roche have submitted applications to get Ocrevus approved in more than 50 countries in Europe, Latin America and the Middle East. Ocrevus trials showed that, among relapsing patients, relapse rates were nearly halved compared to those treated with Rebif. Many of these patients also reached a level of no disease activity — measures that Genentech has continued to explore after the drug's U.S. approval. In addition, data also showed that PPMS patients, who deteriorate more rapidly, benefit from Ocrevus treatment. “People with PPMS [primary progressive multiple sclerosis], who often experience faster and more severe disability, have not had any approved treatment until Ocrevus," Horning said. "We continue to work closely with regulatory authorities across the world to bring Ocrevus to people with multiple sclerosis as soon as possible." Ocrevus is an antibody that blocks the CD20 molecule on certain immune B-cells. Researchers believe these cells directly damage myelin — the protective coat that insulates nerve cells in the brain and spinal cord. Evidence also indicates that B-cells can directly damage neurons themselves. The drug continues to be evaluated in a range of clinical trials, including one that specifically focuses on how the drug’s B-cell depleting actions play out to harness MS disease processes.