MedDay Pharma’s MD1003 leads to long-lasting improvements in progressive multiple sclerosis patients’ disability, a Phase 3 clinical trial follow-up study shows. Researchers presented the results at the third Annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum in San Diego, Feb. 1-3. The poster presentation was titled “…

Multiple sclerosis patients with high relapse rates but less physical impairment before starting on  Novartis’ Gilenya (fingolimod) are likely to experience a surge in disease activity if they stop the treatment, researchers in Turkey report. The study, which dealt with patients with relapsing forms of MS, referred to the surge as "severe disease reactivation," or SDR. Researchers published their article, “Factors Predictive of Severe Multiple Sclerosis Disease Reactivation After Fingolimod Cessation,” in the journal The Neurologist. Studies have shown that Gilenya, which the U.S. Food and Drug Administration approved in 2010, can benefit adults with relapsing MS. It reduces annualized relapse rates and prevents more brain lesions from forming, compared with standard interferon treatments. Lesions are damaged nerve cell areas. Despite its benefits, Gilenya is not recommended for patients with heart or liver problems, low levels of white blood cells, severe herpes virus infections or other infections. Also, patients who do not respond to Gilenya and women who are planning to become pregnant are advised to stop the treatment. Discontinuing Gilenya can lead to a return to pretreatment disease activity, or severe disease reactivation, in some patients. It is unclear why this happens and why it affects only some patients. To better understand what risk factors could be associated with reactivation, a team at Istanbul University compared the demographic and disease features of patients who developed SDR after stopping treatment with Gilenya. SDR was defined as including these elements within 6 months of Gilenya discontinuation: more than 5 gadolinium-enhanced lesions or a tumefactive demyelinating lesion detectable by magnetic resonance imaging, the disease progressing to the point that additional treatment with methylprednisolone or plasma exchange was required, and progressive physical disability reflected by a 1-point or more increase in patients' scores on the Expanded Disability Status Scale, or EDSS, Thirty-one patients at the university’s MS clinic who had discontinued Gilenya were included in the study. Eight experienced SDR and 11 relapses. The mean time for SDR patients' reactivation to occur was 2.6 months, researchers said. Patients had significantly higher levels of lymphocytes — white blood cells involved in autoimmunity — than during Gilenya treatment. When the team compared the disease features of SDR and non-SDR patients, they found that SDR patients had significantly higher annualized relapse rates before starting Gilenya and lower EDSS scores. “A higher ARR [annualized relapse rate] is the major contributory factor toward development of SDR,” the researchers wrote. “Patients who had higher ARRs before fingolimod [Gilenya] treatment must be closely followed up both clinically and radiologically in terms of the early signs of severe reactivation,” they wrote. About 38 percent of the SDR patients failed to respond to steroid treatment. They received a plasma exchange, which led to moderate improvement in their condition. Based on this finding, the researchers suggested that “plasmapheresis [plasma exchange] must be considered in patients exhibiting steroid-refractory SDR.” "In conclusion, SDR may be observed within the first 3 months after cessation of fingolimod," the team wrote. "This may be explained by the rapid influx of lymphocytes into the CNS [central nervous system]. Patients with higher annualized relapse rates and lower Expanded Disability Status Scale scores before commencing fingolimod treatment were more likely to exhibit SDR."  

Deep grey matter volume loss in the brain drives multiple sclerosis (MS) progression and disability, and is particularly evident in people with progressive forms of the disease, a retrospective multi-center study suggests. The study “Deep grey matter volume loss drives disability worsening in multiple sclerosis” was published in…

Tailored molecular treatments for specific disabilities may be a breakthrough for multiple sclerosis (MS) patients, finds a new study by researchers at University of California-Los Angeles (UCLA). The study, “Cell-specific and region-specific transcriptomics in the multiple sclerosis model: Focus on astrocytes,” appeared in the journal Proceedings…

Multiple sclerosis patients should be routinely assessed for chronic and, especially, neuropathic pain in order to properly diagnose and treat this condition, which appears to directly affect the degree of a patient's disability, a new study reports. Pain is one of the most disabling clinical symptoms of MS, associated with suffering, distress, and lower quality of life. Many studies have investigated the prevalence of chronic pain in MS patients but with highly varying results: estimates range from 29 percent up to 92 percent. This disparity is likely due to methodological differences between the studies, as well as differences in the studied population. The result is the prevalence of pain in MS is still unclear, and underdiagnoses of pain in this patient population likely. Researchers in Italy conducted a single-center study to determine the prevalence and characteristics of chronic pain, defined as constant pain for more than three months, in a population of MS patients. Pain was evaluated using validated tools, and the results were analyzed in relation to clinical features such as disease duration and disability. In total, 374 MS patients with different disease severities were assessed for pain. Results found an overall prevalence of chronic pain of 52.1, most frequently affecting the lower limbs. Neuropathic pain, which refers to pain resulting from a lesion or disease impacting the sensory nervous system, was the most frequent type of chronic pain, affecting 23.7 percent of the patients analyzed. Pain intensity was also found to be significantly higher in patients with neuropathic pain compared to those with non-neuropathic pain. Researchers measured patients' disability using the Expanded Disability Status Scale. They determined that patients with chronic pain, and especially those with chronic neuropathic pain, had significantly higher EDSS scores (meaning greater disability) than those without such pain. Both these patient groups were also more likely to be on long-term pain medications: 33 percent of MS patients with neuropathic pain, and 24 percent of those with chronic pain. These results indicate that pain is underdiagnosed and undertreated in MS patients, and a factor that may contribute to increased disability. “Our results suggest that clinical disability is higher in MS patients with chronic pain and, in particular, in those with neuropathic pain,” the researchers concluded. “The present study supports the routine assessment of neuropathic pain in MS patients.”

Using balloons to enlarge veins so that more blood flows out of the brain and spinal cord fails to help multiple sclerosis patients, according to a clinical trial in Italy. Researchers said the procedure did not improve their functioning or reduce their brain lesions — areas where toxic protein build-ups…

Australia has approved a shorter treatment regimen of Merck’s Mavenclad for relapsing-remitting multiple sclerosis. The Therapeutic Goods Administration authorized 20-day courses of the cladribine tablet form of the medication once a year for two years. The regimen reduces relapse rates and the progression of the disease for up to four years, Merck said. The new approval came after Merck submitted additional clinical trial findings on the therapy. Health Canada and the European Commission approved Mavenclad earlier this year. Merck continues to seek its regulatory approval in the United States and other countries. "Mavenclad will be a welcomed treatment option for patients with the relapsing-remitting form of MS,” Bill Carroll, clinical professor of neurology at the University of Western Australia and the Perron Institute, said in a press release. “As an oral therapy taken in two short courses over a two-year period, Mavenclad will be convenient for all eligible patients in Australia, including those who may not live close to their treating healthcare professional," added Carrol, a neurology consultant at the Sir Charles Gairdner Hospital as well as president-elect of the World Federation of Neurology. Mavenclad targets immune cells that trigger relapsing MS. Multiple sclerosis is an autoimmune disease, or one in which the immune system attacks healthy cells. Mavenclad inhibits harmful immune T- and B-cells without suppressing the entire immune system. Australia based its approval of the drug on the findings of a number of clinical trials, including the Phase 3 CLARITY, CLARITY EXTENSION and ORACLE-MS studies, the Phase 2 trial ONWARD study, and the long-term PREMIERE studies. The trials involved more than 2,700 RRMS patients, some of whom were followed more than 10 years. The trials showed that Mavenclad can significantly reduce relapse rates, disability progression and brain atrophy. Doctors recommended the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments. "We are pleased the Therapeutic Goods Administration has updated the product Information for Mavenclad in Australia to reflect additional clinical data," said Simon Sturge, chief operating officer of Merck's biopharma business. "Our next step is to work closely with the Australian government to bring this treatment advance to patients as quickly as possible."

Canadians with relapsing-remitting multiple sclerosis can now receive Merck’s Mavenclad, now that Health Canada has approved Mavenclad as a therapy to reduce the frequency of MS exacerbations and delay disease progression. Merck expects the drug to be commercially available by early January 2018 throughout Canada, which has the world's highest MS rate. This follows the drug’s approval by the European Commission in August, making Mavenclad Europe's first approved highly efficient, oral short-course therapy for relapsing MS. Merck said it would seek regulatory approval of Mavenclad in other countries, including the United States. Mavenclad was designed to selectively target immune cells that trigger relapsing MS, while resetting the immune system. With two annual courses of treatment for a maximum of 20 days over two years, the oral drug promotes long-term inhibition of harmful immune T- and B-cells, without continuous suppression of the immune system. Researchers evaluated Mavenclad in five clinical trials: Phase 3 trials CLARITY, CLARITY EXTENSION and ORACLE-MS; the Phase 2 trial ONWARD study ; and the long-term study PREMIERE. These involved more than 2,700 RRMS patients, some of whom were observed for more than 10 years. Clinical data showed that Mavenclad can significantly reduce disability progression, annualized relapse rates and brain atrophy. The treatment is generally recommended for patients who failed to respond adequately, or are unable to tolerate, one or more MS therapies.

Multiple sclerosis patients who adhere strictly to their medication pay more but stay healthier in the long run than those who don't, a study found. Researchers at Liberty University College of Osteopathic Medicine in Lynchburg, Virginia, analyzed data from 2004 to 2013, including electronic health records, insurance claims and self-reported medication adherence. They based their assessment of health outcomes on inpatient admission, emergency room visits, outpatient appointments  and healthcare costs. In total, 681 participants answered questionnaires about medication adherence and disease outcomes, including the Multiple Sclerosis Impact Scale and the Kurtzke Expanded Disability Status Scale. Also used was the Treatment Satisfaction Questionnaire for Medication to assess satisfaction with the medication taken. Patients who took their medicines most rigorously reported 14 percent less severe physical impact of MS, and 17 percent less severe psychological impact than those with low adherence. These patients also reported a 12 percent decrease in disability level, and believed their treatment plan was 7 percent more effective. However, the total overall costs were higher for patients who adhered to their doctor's orders. The researchers said it's more difficult to detect improvements in health outcomes for MS than for other chronic illnesses. This is partly because the only test for changes in disease status is brain imaging, which is expensive and not done routinely. Furthermore, brain imaging only detects new lesions following a relapse, which cannot be compared to previous or future imaging in a quantifiable way. In fact, no simple tests exist for measuring disease severity in MS as there are in other chronic diseases, making it difficult to determine whether treatment benefits justify their cost.

Though I don’t always use it, I take my cane with me every time we go shopping. I can still shuffle to the cart pickup and drop-off without it and the cart doubles as my walker. Canes can be clunky, aren’t easily stored, and I simply…

Gilenya (fingolimod) was seen to significantly reduce relapses in children and teenagers with multiple sclerosis (MS), according to data from a Phase 3 study — the first successfully conducted in pediatric patients. Novartis, the therapy’s developer, is preparing to file requests for Gilenya to be approved to…

A clinical study now enrolling people with progressive or relapsing multiple sclerosis (MS) will examine the feasibility of older patients stopping use of disease-modifying therapies if they have had no relapses for a number of years. John Corboy, with the University of Colorado School of Medicine, presented the study at…

While early use of high-efficacy treatments lowers relapse rates among patients with relapsing-remitting multiple sclerosis (MS) compared to lower-efficacy ones, starting these therapies earlier may only impact the accumulation of disability among young patients, according to data presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, France. Earlier treatment…

After the first round of symptoms, multiple sclerosis can stay mild without causing major problems for decades, a 30-year British study indicates. Karen K. Chung of the University College London Institute of Neurology discussed the findings at the ECTRIMS-ACTRIMS meeting in Paris, which started Oct. 25 and runs until 28. His presentation was titled “Does…

Radiologically isolated syndrome (RIS) is a rare and relatively recent condition in which people have multiple sclerosis (MS)-like brain and spinal cord lesions without showing disease activity. But since the establishment of the RIS diagnosis, researchers have not reached an agreement on whether these patients should receive MS disease-modifying therapies.

MD1003, a high-dose biotin developed by MedDay, slowed or prevented further disease progression among progressive multiple sclerosis (MS) patients in a Phase 3 clinical trial, researchers announced at the Oct. 25–28 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, France. The effects of the treatment were seen to be upheld over…

Using strategies to promote intellectual enrichment among patients with pediatric-onset multiple sclerosis could be essential to achieving better cognitive, social, and professional performances during adult life, according to researchers at the University of Florence in Italy. The finding was the subject of an oral presentation titled, “Cognitive reserve is…

A University of British Columbia study found a link between depression and increased disability in women with multiple sclerosis. Dr. Kyla McKay said the study of more than 1,200 patients found no link between anxiety or bipolar disorder and increased disability, however. She presented the findings at the 7th Joint ECTRIMS-ACTRIMS Meeting in…

People with a demyelinating disease associated with antibodies against a myelin oligodendrocyte glycoprotein (MOG), most often develop episodes of optic neuritis (inflammation of the optic nerve) that can be treated with corticosteroids, according to data presented today at the 7th Joint ECTRIMS-ACTRIMS Meeting from Oct. 25-28 in Paris. MOG antibody-associated demyelination is a…

Pain, walking problems and fatigue are factors that most strongly lower self-perceived health in multiple sclerosis (MS), researchers at the New York University Langone Medical Center have found. This challenges current treatment approaches focus mainly on physical disability. It suggests that “invisible disability” may be more important to how patients…

Probiotics may improve the health of people with multiple sclerosis (MS) by reducing disability and improving inflammatory and metabolic parameters, an Iranian study shows. Live microorganisms linked to health benefits, known as probiotics, have long been known to help chronic disease patients. In a previous study of people with major depressive disorder, probiotics treatment for eight weeks improved patients’ depression and metabolic parameters. More recently, authors investigated the impact of probiotics on a group of MS patients, looking not only at mental health and metabolic indicators, but also disability scores. Researchers at Tehran's Shahid Beheshti Hospital recruited 60 MS patients, divided them in half, and assigned 30 to take a probiotic capsule and 30 a placebo once a day for 12 weeks. The probiotic contained the healthy bacteria Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum and Lactobacillus fermentum. Researchers measured patients’ health parameters and disability scores at baseline and after treatment. The results showed that probiotic intake after 12 weeks improved MS patients' disability scores (assessed by the expanded disability status scale, EDSS) when compared to placebo controls. Although this improvement was statistically significant, it was not clinically significant — which is defined as a change of 1.0 point or more at EDSS levels less than 5.5, or 0.5 point or more at EDSS levels greater than 5.5). Moreover, benefits were also detected in several mental health parameters – Beck Depression Inventory, general health questionnaire-28 (GHQ-28), depression anxiety and stress scale. Consuming probiotic capsules also significantly decreased insulin levels and high-density lipoprotein (HDL) cholesterol in circulation, researchers also found. It also lowered certain markers of inflammation and oxidative stress, such as serum high-sensitivity C-reactive protein (hs-CRP) and malondialdehyde (MDA).

Patients with primary progressive multiple sclerosis have more severe cognitive impairment than those with relapsing-remitting multiple sclerosis, according to a German study that analyzed published data on the topic. PPMS patients did especially poorly on verbal learning and verbal memory tests, said the study, which suggested that PPMS patients need disease management that specifically focuses on their cognitive difficulties, which do not necessarily correlate with the degree of overall disability. The study gathered data from 47 previously published studies in an attempt to analyze potential differences in cognitive performance between patients with RRMS and PPMS. These studies included 4,460 patients — 3,456 with RRMS and 1,004 with PPMS — and plenty of information about patient and disease features. This allowed researchers to perform a meta-analysis of pooled data from various studies, that is considered the highest level of scientific evidence. Researchers noted that PPMS patients performed worse on cognitive tests, both when considering global scores and tests of specific cognitive domains. Yet both groups scored similarly in levels of anxiety, depression and fatigue. Using statistical analyses, the research team found that differences in sex, education, disease duration, manual dexterity and fatigue could not explain the poorer test results among PPMS patients. On the other hand, PPMS patients were, on average, older than those with relapsing disease, and the team found that this difference accounted for poorer test results in cognitive tests of processing speed and working memory. Yet differences in other cognitive aspects also remained when researchers took age into account. Differences in disability, measured by the Expanded Disability Status Scale, could also not explain why PPMS patients performed worse on the cognitive tests. A detailed look revealed that the largest differences between RRMS and PPMS patients were in verbal learning and verbal memory, along with the age-associated difference in processing speed. Depression and anxiety also brought down processing speed, researchers said, even though the two groups did not differ in their levels of anxiety and depression. The data shows that cognitive impairment in MS is not directly related to the course of the disease. Research may explain differences in other factors including genetics, the degree of brain tissue loss and medications.

I had always envisioned that I would be an active and healthy grandparent when the time came — not one with a disability. I was diagnosed with primary progressive multiple sclerosis (PPMS) in the summer of 2010, which also happened to be the same year my first grandchild…

Older men with multiple sclerosis (MS) have more harmful lifestyles than older women with the disease, concludes the Canadian Survey of Health, Lifestyle and Aging with Multiple Sclerosis. Treatment for depression could go a long way to promoting more healthy lifestyles for all older MS patients, authors suggest. The study, “…

The European Commission has approved Merck KGaA’s Mavenclad (cladribine tablets) to treat highly active relapsing forms of multiple sclerosis (MS). The Aug. 25 decision in Brussels marks the first approval of a highly efficient oral short course therapy for MS in Europe. Mavenclad has been shown to harness disease activity for…

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.

A recent patient survey reveals that almost one in four people with multiple sclerosis in the U.K. are not aware of available treatments that could help delay the onset of disability, even though a clear majority put disability as a chief worry. The report, funded by Sanofi Genzyme, was conducted by Adelphi…

In a pilot study with patients with multiple sclerosis, high-intensity interval training combined with resistance training improved physical capacity and quality of life in a pilot study of multiple sclerosis (MS) patients — whether or not they were disabled. French researchers at the University of Strasbourg assessed physical capacity, strength and quality of life before the training started, and then again after completing a 12-week exercise program. They divided participants into two groups: one of 18 patients with no disabilities, and a group of eight with disabilities. Participants followed a personalized exercise program involving both high-intensity interval training — a kind of cardiovascular exercise strategy alternating short periods of intense anaerobic exercise with less intense recovery periods — and resistance training to improve muscular strength and endurance. Scientists used a French version of the Multiple Sclerosis Quality Of Life-54 test — a questionnaire filled out by MS patients to measure health-related quality of life — with five additional questions. After the exercise program, women improved significantly in vitality, general well-being and physical health composite scores in the quality of life assessment, while men showed no significant improvements. Vitality and general well-being only improved in the group with no disability. Peak oxygen consumption improved by 13.5 percent, and maximum tolerated power — a measure of maximum energy that can be expended — by 9.4 percent. Muscle strength increased in both quadriceps and hamstrings. Women showed better improvements than men in peak oxygen consumption, maximal tolerated power, strength in both quadriceps and hamstrings, and quality of life. Both groups showed increased peak oxygen consumption and strength. “Our study has shown that high-intensity interval training combined with resistance exercise training induced an improvement in physical capacity and quality of life. Moreover, this study allowed patients, irrespective of their sex or EDSS [Expanded Disability Status Scale] score, to resume exercise autonomously,” the team wrote. "High-intensity interval training is well tolerated too and can be used in clinical rehabilitation with resistance training, in both men and women with and without disabilities."

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…