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Archive for the tag “therapy”

30 May 2017

New MS Research

This month in Lancet Neurology, a Canadian research team reports there is a pre-clinical phase in MS. The study used health administration records from four Canadian provinces (British Columbia, Saskatchewan, Manitoba, and Nova Scotia). Due to the nature of the Canadian health-care system, these provinces have computerized health-care records on >99% of residents, including hospital discharges, physician billing, prescription on records, and dates of all medical visits – all records can be linked by a unique health-care number assigned to individuals. Using these records, medical histories for 14,428 MS cases and 72,059 controls were included for this study. They compared health-care utilization in the same five-year period prior MS diagnosis between cases and temporally matched controls.

Interestingly, five years before a MS diagnosis, the number of hospital admissions for people who eventually developed MS was 26% higher than controls, and this increased to 78% higher a year before MS diagnosis. A similar pattern was observed for physician billing (5 years before diagnosis: 24% higher in people with MS than controls; 1 year before diagnosis: 88% higher in people with MS than controls). There was also a substantial increase in the number of prescribed drug classes in people with MS compared to controls (5 years before diagnosis: 23% higher; 1 year before diagnosis: 49%  higher). These results clearly demonstrate a pre-clinical stage for MS where subtle symptoms exist before clinically definitive symptoms (also known as a prodromal stage). With further research, we can explore these subtle symptoms and hopefully diagnose MS earlier and initiate therapeutics earlier, slowing the rate of progression of MS.

From: When do MS symptoms start? By Farren Briggs PhD, ScM; The Accelerated Care Project for Multiple Sclerosis

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24 Sep 2016

Positive Results Announced from Clinical Trial of BAF-312 (Siponimod) in Secondary Progressive MS

Summary

Results presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) provided additional details from a 60-month, phase III clinical trial of the experimental oral therapy siponimod (BAF312, Novartis Pharmaceuticals AG) involving 1,651 people with secondary progressive MS.

The trial met its primary endpoint of reducing the risk of disability progression compared with inactive placebo. Those on active treatment had a 21% reduced risk of disability progression compared to those on placebo. Secondary endpoints suggested that those on active therapy had 23.4% lower average change in brain volume and reduced lesion volume.

The therapy was generally well tolerated and similar to adverse events reported for similar compounds.

Details

Background: Siponimod (BAF312) is an experimental immune system-modulating therapy that was designed to be a more selective sphingosine 1-phosphate receptor modulator than Gilenya® (fingolimod, Novartis International AG). Gilenya, was approved in 2010 for adults with relapsing forms of MS to reduce the frequency of clinical relapses and to delay the accumulation of physical disability. Siponimod previously demonstrated safety and efficacy on MRI scans in a phase II study in people with relapsing-remitting MS (The Lancet Neurology, 2013 Aug;12(8):756-67).  Siponimod is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system. Siponimod also distributes effectively to the central nervous system (brain and spinal cord) where it may have direct anti-inflammatory or other effects.

The Study: Participants were randomly assigned to take siponimod or placebo capsules daily for up to 60 months. The primary endpoint of the study was reducing the risk of disability progression, as measured by the EDSS scale at three months. Secondary endpoints included reducing the risk of disability progression as measured by the EDSS at six months versus placebo, the risk of worsening mobility as measured by the timed 25-foot walk test, disease activity as observed on MRI scans, relapse rate, and safety/ tolerability.

Results:  Results were presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on September 17, 2016. The trial met its primary endpoint of reducing the risk of disability progression compared with inactive placebo. Those on active treatment had a 21% reduced risk of disability progression (confirmed at 3 months) compared to those on placebo. Secondary endpoints suggested that those on active therapy had at 26% reduced risk of disability progression (confirmed at 6 months), a 23.4% lower average change in brain volume, and reduced MRI-detected brain lesion volume. There was no significant difference seen between groups in the timed 25-foot walk. Relapse rates were significantly lower in those taking siponimod.

Safety: The therapy was generally well tolerated and similar to adverse events reported for similar compounds. Serious adverse events occurred in 16.7% of participants. The serious adverse events reported to be more likely for those taking siponimod included nervous system disorders and infections.

Comment: “These results suggest a modest benefit for people with secondary progressive MS, which is a positive step forward in the global effort to speed solutions for people living with this chronic form of the disease,” said Timothy Coetzee, PhD, Chief Advocacy, Services and Research Officer at the National MS Society. “We look forward to learning additional details about its potential benefit and safety.”

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13 Aug 2016

Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial

Publication History

Published Online: July 06, 2016

http://www.msard-journal.com/article/S2211-0348(16)30100-6/fulltext#s0005

The role of diet in ameliorating the severity of multiple sclerosis (MS) has been long debated, but there remains a paucity of relevant research. Observational studies by Dr. Roy Swank, published between 1953 and 2003, suggested significantly reduced MS disease activity and disability progression and longer survival in people following a diet low in total and saturated fat compared with those who did not (Swank, 1953, Swank and Goodwin, 2003, Swank, 1970). Swank’s diet book, last published in 1987, remains popular among patients with MS. However, this approach to treating MS has never been subjected to a well-controlled clinical trial.

The supposed large clinical effect of the Swank low fat diet led to our hypothesis that a very-low-fat, plant-based diet might have a large effect on MRI activity. We conducted a pilot study to explore the tolerability and potential benefits of a very-low saturated fat, plant-based diet followed for 12 months by people with relapsing-remitting MS (RRMS) with the primary endpoint being brain MRI disease activity.

 

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28 Jul 2016

Study suggests antibody may have therapeutic effect on MS

Researchers have developed an antibody with potential therapeutic effects against multiple sclerosis. The discovery opens up a new strategy for controlling the disease.

For the cells of the immune system circulating in the bloodstream to reach the central nervous system, they must penetrate the blood-brain barrier and blood-spinal cord barrier. During previous work, the authors studied a factor involved in opening the blood-brain barrier, the NMDA receptor. They found that blocking the interaction of this receptor with tPA has beneficial effects linked with maintaining the integrity of the barrier.

Scientists at the Institut National de la Santé et de la Recherche Médicale, in France, developed a monoclonal antibody (Glunomab) directed against the specific site on the NMDA receptor to which tPA binds. In cellular models of the human blood-brain and blood-spinal cord barriers, the use of this antibody prevented opening of the barrier under inflammatory conditions, limiting the entry of lymphocytes. The team then tested the therapeutic effects of the antibody in an experimental mouse model of MS. After intravenous injection of Glunomab, the progression of partial or total paralysis of the limbs – as assessed by a clinical score – was blocked. In these treated mice, this effect was linked with reduced infiltration of lymphocytes into the nervous tissue, and reduced demyelination.

Results of mouse model studies sometimes do not translate to humans and may be years away from being a marketable treatment. However, the authors argue that by preventing myelin destruction by the cells of the immune system, this strategy might represent a promising therapy for the control of MS.

The study was published in the journal Brain.

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10 Jul 2016

Study Shows Expansion of Stem Cell Clinics in the U.S. and the Need for Better Oversight

Researchers have published a paper describing the proliferation of stem cell clinics in the United States and ethical issues and regulatory concerns that come with marketing unproven treatments for many conditions. Their study shows that many different types of unproven stem cell treatments are being offered, and highlights concerns for the safety of people who undergo these treatments.

There is exciting progress being made through innovative research related to the potential of many types of stem cells for slowing MS disease activity and for repairing damage to the nervous system. At present, there are no approved stem cell therapies for MS. People need the best available information to understand this exciting area of research and make decisions related to this complex issue.

The paper’s findings support the need for stem cell therapy to be explored in the context of carefully conducted clinical trials that can determine what the optimal cells, delivery methods, safety and actual effectiveness of cell therapies might be for people with MS.

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04 Jun 2016

Canadian Researchers Uncover Rare Gene that Increases Risk of Progressive MS

Researchers at the University of British Columbia have uncovered a rare gene mutation that appears to dramatically increase the risk, in some individuals, of developing a severe form of progressive multiple sclerosis. While the cause of MS is not known, scientists believe several different factors, including susceptibility genes, may interact to trigger the disease. The gene was discovered in two unrelated families that had multiple members with MS. The researchers also determined that the gene (NR1H3) contains instructions for a protein called LXRA, which is thought to be a control switch for genes involved in many functions, including some that help control inflammation and integrity of nerve-insulating myelin in the brain and spinal cord. This type of discovery can provide crucial clues to biological pathways that underlie MS, and may lead to new approaches for stopping MS and restoring function. The study, by Drs. Carles Vilariño-Güell, Weihong Song, A. Dessa Sadovnick and others, was funded in part by the MS Society of Canada and appeared in the journal Neuron on June 1, 2016.

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16 May 2016
1 Comment

German Study Suggests Leukemia and Colorectal Cancer Rates Increased with Mitoxantrone Use for MS

Summary

  • A study of 676 people with MS treated with the MS therapy mitoxantrone in Germany reveals that the rates of acute myeloid leukemia (a type of cancer) and colorectal cancer were significantly increased above what would be expected in the general population there. Rates of other cancers were not increased.
  • The authors note that if the findings are confirmed, recommending colonoscopy after treatment may be advisable, since if found early enough, colorectal cancer is curable.
  • The team (led by Dr. Mathias Buttmann, University of Würzburg, Germany) has published results in Neurology (published early online, May 11, 2016).

Background: Mitoxantrone is a powerful immune-suppressing therapy. Prior to its approval for use in MS, it was used only to treat certain forms of cancer. It acts in MS by suppressing the activity of immune T cells, B cells, and macrophages that are thought to lead the attack on nerve-insulating myelin. The U.S. Food and Drug Administration approved mitoxantrone for reducing neurologic disability and/or the frequency of relapses in people with secondary progressive MS or worsening relapsing-remitting MS. The total lifetime dose is limited to avoid possible heart damage. Acute myeloid leukemia has been previously reported in people treated with mitoxantrone for MS or cancer.

The Study: Investigators identified 677 people with MS seen at the University of Würzburg MS center between January 1994 and December 2007 who had received mitoxantrone. They were able to follow up with 676 of these patients.

The results show that 37 people developed cancer after taking mitoxantrone, including nine cases of breast cancer, seven cases of colorectal cancer, and four cases of acute myeloid leukemia. The rate of acute myeloid leukemia was 10 times that seen in the general population in Germany. The rate of colorectal cancer was three times that seen in the general population in Germany. The rate of breast and other cancers was not increased over that seen in the general population in Germany. Older age at treatment was associated with increased risk of cancer, but not prior use of other immunosuppressive treatments, or duration of treatment with mitoxantrone.

The team (led by Dr. Mathias Buttmann, University of Würzburg, Germany) has published results in Neurology (published early online, May 11, 2016).

Comment: The authors state that if the findings are confirmed, “posttreatment colonoscopy might improve the risk-benefit ratio of this highly active immunosuppressive drug,” since if found early enough, colorectal cancer is curable. They also note that mitoxantrone is currently the only MS therapy approved for treating secondary progressive MS, and that the overall rate of cancers may still justify the use of mitoxantrone in people who are severely affected with MS and where there are no better treatment options available.

Read more about mitoxantrone
Read more about treating secondary progressive MS
Read more about making treatment decisions in MS

 

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01 May 2016

Multiple Sclerosis in Russia

From the Russian Multiple Sclerosis Society (http://www.armss.ru/)

Multiple Sclerosis (MS) is a severe chronic disease of the brain and spinal cord, which affects relatively young people and oftentimes results in disabilities. Over recent years, MS has tended to rapidly grow in frequency with onset among younger patients. This was caused by not only better diagnostic facilities for MS but also improvement of the quality of epidemiological research, yet the actual growth of the disease is also a reason. Currently, there are over 150,000 patients in Russia, of whom no less than 75% are already disabled. While including the families of patients and disabled people, MS as a problem involves from 750,000 to 1 million Russian citizens.  At present, there are about 3 million people with MS in the world. The MS frequency in Russia is from 30 to 100 per 100,000 of general population.

In Russia,

70%    families break up after one of the spouses is diagnosed

29%    patients have not left their homes for over a year

78%   patients are females under 50

75%    patients have disabilities

35%    are young people under 28

6%     are children aged 10-15

Medical and social support for PwMS is a challenging and complex task, which cannot be resolved otherwise but in close cooperation between civil institutions, as well as expert and public ones. Since the course of the disease is unpredictable with the end deemed practically inevitable, while diagnostic facilities were untimely and pathogenic therapies were highly expensive and disabilities growing, some time ago patients with MS would not often get an adequate medical and social treatment as they were regarded as having no prospects. With introducing a range of medicines in the 90s of the 20th century to modify the course of multiple sclerosis (or, disease modifying drugs – DMDs), then, new medical and rehabilitation techniques, patients got a hope for the pathological process development to slow down, to prolong physical activity and working ability and quality of life.

However, MS requires overall significant resources employed being financial, organizational, scientific-methodic, social. In the 90s of the last century, the problem remained little-known and was considered by professionals as a specific scientific-medical one. For a long time, authorities and professional and general communities underestimated its high social significance and the necessity to concentrate on considerable efforts to fight it.

Nurse assistance services have been set up in 55 regions that carry out target medical maintenance of patients receiving highly expensive medicinal therapy. Nurses render consulting medical and social assistance to people with MS.

The crowning achievement of the ARMSS is that it has managed to translate, in the general public mind, MS as a problem from the ‘scientific and medical’ category into the ‘social and economic’ one, as well as to improve the quality of rendering medical assistance to Russians suffering from MS.  The most outstanding result of this understanding became the guaranteed provision of highly expensive medicines (DMDs) for patients with MS at the expense of federal and regional budgets, which had been unthinkable of in the early 2000s.

The improvement of quality of life of people with MS is a result of combined activities of structures of civil society and authorities.

(after:  Patient voluntary organizations’ role in improving the quality of rendering social and medical assistance to communities. by Yan V. Vlasov – MD, Mikhail Al. Kurapov, Mikhail V. Churakov – PhD)

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24 Jan 2016

The Latest on Stem Cell Treatment

Recent media reports have featured news about a clinical trial involving harvesting a person’s own stem cells to treat aggressive multiple sclerosis.
• This treatment, called autologous haematopoietic stem cell transplant (HSCT), attempts to “reboot” the immune system, which is believed to launch attacks on the brain and spinal cord in people with MS.
• HSCT is under investigation in clinical trials in Canada, the United States, Europe and elsewhere. Clinical trials are needed to fully understand the benefits and risks of HSCT in MS, and who might benefit most from this approach, since it does not seem to be effective in all types of MS.
• In HSCT, stem cells from a person’s own bone marrow or blood are stored, and the rest of the individual’s immune cells are depleted usually by chemotherapy. Then the stored stem cells are reintroduced and over time they produce new cells that repopulate the body with immune cells.
• There is exciting progress being made through innovative research related to the potential of many types of stem cells both for slowing MS disease activity and for repairing damage to the nervous system.
• At present, there are no approved stem cell therapies for MS. Stem cell therapy is in the experimental stage, and it’s important for people to have the best available information to understand this exciting area of research and make decisions related to this complex issue.
• In November 2015, the International Conference on Cell-Based Therapy for Multiple Sclerosis was convened by the National MS Society and the European Committee for Treatment and Research in Multiple Sclerosis, bringing leading researchers and clinicians together to confer on clinical trials needed to provide answers about which types of cells, which route of delivery, and which types and stages of disease, would be the most promising approach for treating MS. A summary and consensus on next steps will be published by the conference organizers, with recommendations to help speed the development of new cell-based treatment solutions.
• With the urgent need for more effective treatments for MS, particularly for those with more progressive forms of the disease, we believe that the potential of all types of cell therapies must be explored. The Society is currently supporting 12 research projects exploring various types of stem cells, including cells derived from bone marrow, fat and skin, and has supported 68 stem cell studies over the past 10 years.

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20 Dec 2015

New Study Suggests People with MS are at Increased Risk for Depression, Anxiety and other Psychiatric Disorders

Summary
• A large-scale study from Canada suggests that people with MS have increased rates of anxiety, bipolar disorder, depression, and schizophrenia compared to people without MS.
• Among people with MS, women were more likely than men to develop depression, anxiety disorder, and bipolar disorder, while men were more likely than women to develop schizophrenia. Although women with MS were more likely to develop depression than men, men developed depression at a much higher rate compared to men without MS.
• This study provides new information about the risks of psychiatric disorders in people with MS. Recognizing and addressing issues related to mental and emotional health can greatly improve quality of life for individuals and families.
• The National MS Society is focusing a light on psychosocial issues and emotional health in MS as part of its commitment to drive research and programs in wellness.
• The team (Ruth Ann Marrie, MD, PhD) published their results in Neurology (2015;85:1–8).
Details
Background: In scientific terms, having two chronic medical conditions at once is called “comorbidity.” There is growing recognition that comorbidities may complicate the diagnosis of MS and also influence disease progression, as well as an individual’s wellness and quality of life. It has long been known that depression and bipolar disorder are more common among people with MS than in the general population. In a recent study from Dr. Marrie and others, psychiatric disorders (depression and anxiety) were among the five most prevalent disorders occurring alongside MS. The current study specifically looks at psychiatric comorbidities in people with MS.

The Study: The team identified 44,452 persons with MS and 220,849 controls without the disease in administrative medical data from four Canadian provinces. They examined medical records to determine the incidence (new cases) and prevalence (all existing cases) of depression, anxiety, bipolar disorder, and schizophrenia from 1995 to 2005 among these groups.

The results show that the incidence and prevalence of anxiety, bipolar disorder, depression, and schizophrenia were all higher in people with MS than in people without MS in the control population. Among people with MS, women were more likely than men to develop depression, anxiety disorder, and bipolar disorder, while men were more likely than women to develop schizophrenia. Although women with MS were more likely to develop depression than men, men developed depression at a much higher rate compared to men without MS.

Results were published in Neurology (2015;85:1–8).

Next Steps: This study adds to a growing body of evidence on conditions that occur alongside MS. The National MS Society is focusing increased attention on psychosocial conditions in MS as part of its commitment to drive research and programs in wellness. Read more

In the face of a chronic, often progressive illness like MS, people may tend to focus primarily on their physical health and neglect their emotional health — which is an essential component of overall health and wellness. Recognizing and addressing issues related to mental and emotional health can greatly improve quality of life for individuals and families. Read more about emotional health and MS

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