Generic Multiple Sclerosis Drug Found Equivalent To Brand Medication

Dr. Jeffrey Cohen MD Director Mellen Center for Multiple Sclerosis Treatment and Research Director of the Experimental Therapeutics Program Cleveland Clinic Main CampusMedicalResearch.com Interview with:
Dr. Jeffrey Cohen MD
Director
Mellen Center for Multiple Sclerosis Treatment and Research
Director of the Experimental Therapeutics Program
Cleveland Clinic Main Campus

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Cohen: Medications are a major contributor to the high cost of Multiple Sclerosis (MS) care.  As medications go off patent, there is the opportunity to develop generic versions with lower cost.  This trial was conducted after extensive in vitro and animal studies supported the equivalence of a generic glatiramer acetate to the brand drug Copaxone. The trial showed that generic and brand glatiramer acetate have equivalent efficacy as measured by MRI and clinical endpoints, safety, and tolerability.

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Study Suggests Further Research of Melatonin To Decrease MS Relapses Warranted

MedicalResearch.com Interview with:
Dr.
Mauricio F. Farez
Center for Research on Neuroimmunological Diseases (CIEN)
Raúl Carrea Institute for Neurological Research (FLENI)
Buenos Aires, Argentina

Medical Research: What is the background for this study? What are the main findings?

Dr. Farez: We were intrigued by our initial observation that Multiple Sclerosis (MS) relapses have a clear seasonal occurrence with less relapses during fall and winter. We found that melatonin levels (a hormone secreted by the pineal gland in the absence of light) have an inverse correlation with Multiple Sclerosis relapses. Moreover, melatonin controls the generation of pathogenic Th17 cells, while it boosts the generation of regulatory Tr1 cells. By affecting the immune balance of those cells it may prevents the occurrence of relapse.

Medical Research: What should clinicians and patients take away from your report?

Dr. Farez: Melatonin and drugs alike targeting its pathways may be a future alternative in Multiple Sclerosis  treatment. Until a proper clinical trial is conducted, melatonin SHOULD NOT be used as Multiple Sclerosis therapy. I would like to emphasize this, because melatonin is a complex hormone with receptors present basically in every cell. We do not know yet the dosage and administration form needed to obtain similar effects as the one observed in our in vitro and animal studies.
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Breastfeeding May Reduce Multiple Sclerosis Relapses

PD Dr. Kerstin Hellwig Neurologische Abteilung Universitätsklinikum St. Josef Hospital BochumMedicalResearch.com Interview with:
PD Dr. Kerstin Hellwig
Neurologische Abteilung Universitätsklinikum
St. Josef Hospital
Bochum

Medical Research: What is the background for this study? What are the main findings?

Dr. Hellwig: The relapse risk is elevated in women with Multiple Sclerosis after delivery. We found that women with Multiple Sclerosis who breastfed exclusively had a significant lower relapse risk, than women who did not breastfed at all or breastfed some
but not exclusively. After the introduction of supplemental feedings,
the relase risk was similar between both groups.

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Could Increased Salt In Processed Food Contribute To Rise in MS Cases?

Dimitry N. Krementsov PhD Research Associate University of Vermont Burlington, VT 05405MedicalResearch.com Interview with:
Dimitry N. Krementsov PhD
Research Associate
University of Vermont
Burlington, VT 05405

Medical Research: What is the background for this study? What are the main findings?

Dr. Krementsov:  Multiple sclerosis (MS) is the most common disabling neurologic disorder affecting young adults. The disease is initiated by the individual’s own immune system attacking the central nervous system (brain and spinal cord).Multiple sclerosis is complex and is controlled by the interplay between sex/gender, genetics, and environmental factors. How this happens is not well understood, but an intriguing clue is that MS incidence over the last 50-100 years has been increasing in women and not men, suggesting that a recent environmental change is affecting MS preferentially in females.

There are several well-documented risk factors for Multiple Scleroisis, including Epstein-Barr virus infection, low sunlight exposure, low vitamin D, and smoking. Recent studies have suggested the existence of a new risk factor – high intake of dietary salt. In our study, we sought to understand how this environmental factor may interact with genetics and sex.

We used an animal model of MS, called experimental autoimmune encephalomyelitis (EAE), in laboratory mice. The advantage of this approach is the ability to precisely control both the genetics and the environment, something that cannot be done in epidemiological studies in humans. Just as in previous studies, we found that when mice were fed a high salt diet, their MS-like disease got worse.

Importantly, we found that this was dependent on genetics and sex; when we varied the genetic background of the mice, we saw three different outcomes:
1) an effect of salt in both males and females,
2) an effect only in females, and
3) no effect in either sex.

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Seizure Medication Reduced Optic Neuritis In Multiple Sclerosis

dr-raju-kapoor.jpgMedicalResearch.com Interview with:
Dr. Raj Kapoor
National Hospital for Neurology and Neurosurgery
University College London Hospitals NHS Foundation Trust

Medical Research: What is the background for this study?

Dr. Kapoor: Current treatments for Multiple Sclerosis do not prevent disability which accumulates from relapses, or which progresses between relapses. Experimental work suggests that the neurodegeneration which underlies disability could be prevented using agents which block voltage gated sodium channels. We have tested this possibility using treatment with the sodium channel blocker phenytoin in patients with acute optic neuritis. We tested whether phenytoin could prevent the degeneration seen in the retinal nerve fiber layer and macula after an attack of optic neuritis.

Medical Research: What are the main findings?

Dr. Kapoor: The main findings are that the group of patients treated with phenytoin had less degeneration in the retinal nerve fiber layer (rnfl) and in the macula (mv) in the eye affected by optic neuritis than the group treated with placebo. Phenytoin treatment reduced the degeneration by 30 % (rnfl) – 34% (mv).

Medical Research: What should clinicians and patients take away from your report?

Dr. Kapoor: This is a study designed to test the concept of neuroprotection, and it appears that the treatment was successful. Phenytoin did not lead to better vision after optic neuritis, but our trial was too small to determine whether phenytoin could achieve this. By providing proof of concept for the treatment target, however, and by demonstrating neuroprotection so robustly, we hope to open a door to even better treatments to prevent disability in Multiple Sclerosis.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Kapoor: The trial suggests that proof of neuroprotection using different treatment targets could be sought in similar trials in optic neuritis. Better treatment effects could be achieved by refining the trial design, for example by looking for drugs with more potent effects on the relevant sodium channels, by treating even earlier from the onset of optic neuritis, and by combining such neuroprotection with other treatments to promote remyelination and to suppress inflammation in Multiple Sclerosis.

Citation:

2015 AAN abstract :

Phenytoin is Neuroprotective in Acute Optic Neuritis: Results of a Phase 2 Randomized Controlled Trial

 

MedicalResearch.com Interview with: Dr. Raj Kapoor (2015). Seizure Medication Reduced Optic Neuritis In Multiple Sclerosis 

Computer Based Program Improved Depression in Multiple Sclerosis Patients

Dr Stefan M Gold Institute of Neuroimmunology and Multiple Sclerosis (INIMS) Centre for Molecular Neurobiology, University Medical Center Hamburg-Eppendorf Hamburg, GermanyMedicalResearch.com Interview with:
Dr Stefan M Gold

Institute of Neuroimmunology and Multiple Sclerosis (INIMS)
Centre for Molecular Neurobiology, University Medical Center Hamburg-Eppendorf
Hamburg, Germany

Medical Research: What is the background for this study? What are the main findings?

Dr. Gold: Multiple sclerosis (MS) is a chronic inflammatory disorder of the central nervous system (brain and the spinal cord). In addition to motor symptoms such as walking impairment, patients with Multiple sclerosis frequently suffer from psychological problems including difficulties with learning and memory as well as depressed mood. Depression is particularly common in this patient group with a 3-4 fold elevated risk for developing major depressive disorder compared to the general population. Depression in Multiple sclerosis is associated with decreased quality of life, absence from work, and numerous other psychosocial problems. Despite this major impact on patients’ lives, depression in Multiple sclerosis is often not adequately diagnosed and treated: Antidepressant medication in this patient group often has side effects and the neurological problems associated with MS such as difficulties with concentration and fatigue make it particularly difficult for MS patients to complete “classical” depression treatments such as psychotherapy. The goal of our study was to make psychological treatments available for the many patients with Multiple sclerosis suffering from depression, who often have difficulties to find adequate treatment.

For this study, published in The Lancet Psychiatry, we conducted a randomized controlled trial of a fully-automated, computer-based program that can be accessed directly from patients’ homes over the internet. The program called “deprexis” was developed by the Hamburg-based company GAIA and uses methods of “cognitive behavioral therapy” or “CBT”. Ninety Multiple sclerosis patients were enrolled in the trial and randomly assigned to a 3 months therapy using the deprexis program or a waitlist control group. At the end of the intervention, depression had significantly decreased in the treatment group but remained unchanged in patients who did not have access to the program. In addition, patients using the computer program also reported reduced fatigue and improved quality of life. Continue reading

Could H pylori Be Protective Against Multiple Sclerosis?

Allan G Kermode MBBS MD FRACP FRCP Clinical Professor of Neuroimmunology, Murdoch University Clinical Professor of Neurology, University of Western Australia Head, Department of Neurology and Clinical Neurophysiology SCGH Centre for Neuromuscular and Neurological Disorders Australian Neuromuscular Research Institute Sir Charles Gairdner Hospital Perth WA Australia Institute of Immunology and Infectious Diseases Murdoch University, Western AustraliaMedicalResearch.com Interview with:
Allan G Kermode MBBS MD FRACP FRCP

Clinical Professor of Neuroimmunology, Murdoch University
Clinical Professor of Neurology, University of Western Australia
Head, Department of Neurology and Clinical Neurophysiology SCGH
Centre for Neuromuscular and Neurological Disorders
Australian Neuromuscular Research Institute  Sir Charles Gairdner Hospital Perth WA Australia Institute of Immunology and Infectious Diseases
Murdoch University, Western Australia

MedicalResearch: You found that H. pylori sero-positivity was significantly lower in female patients with MS than in female healthy controls, but you didn’t find such a trend in men with Multiple Sclerosis… Briefly, what might explain this association between H. pylori and Multiple Sclerosis in women? (i.e the hygiene hypothesis I suppose?).

Prof. Kemode: There are a number of possible explanations, but we believe that the most likely is that helicobacter colonisation is a surrogate marker for the baseline levels of exposure to environmental pathogens and organisms during childhood. We have argued this point of view in our manuscript. It should be emphasised that perhaps not all exposure to infectious agents need necessarily be pathogenic, and the concept of the protobiome is an important one. Every healthy (and unhealthy) individual is host to very many organisms, with the gut having the widest diversity. Other explanations for the association might include that there is some specific antigenic interaction occurring promoting specific immune tolerance to CNS antigens, but I believe that this conclusion would be drawing a very long bow with our current stage of knowledge regarding Multiple Sclerosis.

MedicalResearch: Why does this relationship exist in women but not in men? (presumably, they are exposed to the same sanitation, hygiene etc.)

Prof. Kemode: This is arguably one of the most fascinating observations of our study. Historically the sex ratio in Multiple Sclerosis was equal, yet in the last 100 years the prevalence of Multiple Sclerosis has increased markedly and the majority of this increase has occurred in women such that in Australia the sex ratio F:M approximates 3:1. The fact that over the same period prevalence of helicobacter in Western countries has declined markedly is a tantalising observation. At this stage scientific knowledge has not explained the changing sex ratios in Multiple Sclerosis nor can we yet explain the strong helicobacter association in females but not males in our study, but our study provides useful navigation to direct further research.

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No Link Between HPV Vaccine and Multiple Sclerosis

Anders Hviid, M.Sc., Dr.Med.Sci. Senior Investigator, Statens Serum InstitutMedicalResearch.com Interview with:
Anders Hviid, M.Sc., Dr.Med.Sci.

Senior Investigator, Statens Serum Institut

Medical Research: What is the background for this study?

Response: After the widespread introduction of HPV vaccination of adolescent girls, a number of safety concerns have emerged. In this case, demyelinating diseases, including multiple sclerosis, occurring after HPV vaccination has been reported in social media, news media and medical journals.

Medical Research: What are the main findings?

Response: In a study of almost 4 million Danish and Swedish women, we found no support for an increased risk of multiple sclerosis or other demyelinating diseases following HPV vaccination. Continue reading

Multiple Sclerosis: Pilot Study of Immunosuppression Plus Transplantation

Dr. Richard Nash MD Colorado Blood Cancer InstituteMedicalResearch.com Interview with:
Dr. Richard Nash MD
Colorado Blood Cancer Institute

 

Medical Research: What is the background for this study? What are the main findings?

Dr. Nash: Multiple sclerosis is an autoimmune disease of the central nervous system which causes significant disability and in some cases results in patients being wheel-chair bound or bed-ridden. It is a significant medical problem amongst young adults. We undertook this study because current Multiple sclerosis therapies were not adequate for effective long-term control of the disease in the majority of the patients. High-dose immunosuppressive therapy followed by autologous hematopoietic cell transplantation is an effective treatment for many hematological malignancies. It causes a profound immunosuppression. Based on this effect on the immunological system, we initiated a clinical trial of this treatment modified for autoimmune disorders. The study was supported by the Immune Tolerance Network and NIAID, NIH. In a phase 2 clinical trial of 25 patients all of whom were followed for at least 3 years, we demonstrated that 80% of patients had no evidence of disease activity. No other Multiple sclerosis treatments were given after the study treatment. Adverse events were similar to what we have observed for this treatment in patients with hematological malignancies. No significant acute neurological adverse events were observed. Continue reading

Multiple Sclerosis: Generic Copaxone Demonstrates Equivalent Safety and Efficacy

Jeffrey Cohen MD Department of Neurology Cleveland ClinicMedicalResearch.com: Interview with:
Jeffrey A. Cohen, MD
Hazel Prior Hostetler Endowed Chair
Professor, Cleveland Clinic Lerner College of Medicine
Director, Mellen Center for MS Treatment and Research
Neurological Institute
Cleveland Clinic Cleveland, OH  44195

Medical Research: What are the main findings of the study?

Dr. Cohen: The primary objective of the GATE trial was to compare the efficacy and safety of generic glatiramer acetate to the approved form (Copaxone) in relapsing-remitting multiple sclerosis.  The study demonstrated equivalent efficacy of generic glatiramer acetate and Copaxone measured by gadolinium enhancing brain MRI lesions at months 7, 8, and 9 and a number of additional measures of MRI lesion activity.  The study also showed comparable safety (measured by adverse events) and injection site tolerability.

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Multiple Sclerosis: Sleep Disorders Both Common and Underdiagnosed

Steven D. Brass, M.D., M.P.H., M.B.A. PI and Lead Author on the study Director of Neurology Sleep Clinical Program Co-Medical Director of Sleep Medicine Laboratory Associate Clinical Professor in the Department of Neurology UC Davis Health System 4860 Y Street — Suite 3700 Sacramento, CA 95817 MedicalResearch.com Interview with:
Steven D. Brass, M.D., M.P.H., M.B.A.
PI and Lead Author on the study
Director of Neurology Sleep Clinical Program
Co-Medical Director of Sleep Medicine Laboratory
Associate Clinical Professor in the Department of Neurology
UC Davis Health System 4860 Y Street — Suite 3700
Sacramento, CA 95817

Medical Research: What was the primary finding of your study?

Dr. Brass : Among the 11,400 surveys mailed out to all members of the Northern California Chapter of the National Multiple Sclerosis Society, 2,810 (24.6%) were returned. Of these, 2,375 (84.5%) met the inclusion criteria. Among the completed surveys, 898 (37.8%) screened positive for obstructive sleep apnea, 746 (31.6%) for moderate to severe insomnia, and 866 (36.8%) for restless legs syndrome.  In contrast, only 4%, 11%, and 12% of the cohort reported being diagnosed by a health care provider with obstructive sleep apnea, insomnia, and restless legs syndrome, respectively. Excessive daytime sleepiness was noted in 30% of respondents based on the Epworth Sleepiness Scale. More than 60% of the respondents reported an abnormal level of fatigue based on the Fatigue Severity Scale.  There was also an increased risk between complaints of Fatigue based on screening positive for the Fatigue Severity Scale  and screening positive for Obstructive Sleep Apnea  (1.850, with a 95% p-value < 0.001).

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Multiple Sclerosis: Slower Walking Speed Associated With Decreased Quality of Life

Jeffrey Cohen MD Department of Neurology Cleveland ClinicMedicalResearch.com Interview with:
Jeffrey Cohen MD
Department of Neurology
Cleveland Clinic

Medical Research: What are the main findings of the study?

Dr. Cohen: This study assessed the relationship between walking speed, as measured by the Timed 25-foot Walk test, and patient-reported quality of life, as measured by the Physical Component Summary score of the 36-Item Short Form Health Survey (SF-36), in a pooled dataset from the AFFIRM, SENTINEL, and IMPACT multiple sclerosis Phase 3 trials.  It showed that slowed walking speed is associated with decreased quality of life.  It also showed that 20-25% slowing of walking speed is a clinically meaningful change.
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Multiple Sclerosis: High Salt Intake Linked to More Relapses

MedicalResearch.com Interview with:
Dr. Mauricio Farez
Department of Neurology, Raúl Carrea Institute for Neurological Research
Buenos Aires, Argentina

Medical Research: What are the main findings of the study?

Dr. Farez: Our study shows that patients with Multiple Sclerosis (MS) with moderate to high sodium (salt) intake have also increased disease activity (more clinical relapses and more lesions on MRIs).

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Multiple Sclerosis: Clinical Features and MRI Changes of Decision-Making Difficulties

Dr Nils Muhlert Wellcome Trust ISSF Research Fellow School of Psychology Cardiff UniversityMedicalResearch.com Interview with:
Dr Nils Muhlert
Wellcome Trust ISSF Research Fellow
School of Psychology
Cardiff University

Medical Research: What are the main findings of the study?

Dr. Muhlert: Decision making impairments are known to occur in people with multiple sclerosis (MS), and are important, given they can contribute to employment status, treatment compliance and function in everyday life. Studies by Kleeberg, Simioni and others have demonstrated that decision-making impairments can occur early in the course of multiple sclerosis and get worse as the disease progresses. Questions however remain over whether these impairments are linked to more general cognitive difficulties, differences between multiple sclerosis subtypes, and their relationship with MRI changes.

We assessed decision-making and examined MRI changes in a relatively large sample of people with multiple sclerosis (N = 105) and healthy controls (N = 43). All participants performed the Cambridge Gambling Task, which independently measures risk-taking, impulsivity, deliberation and risk adjustment, and underwent an MRI scan including T1-weighted and diffusion MRI sequences.

We demonstrate that people with multiple sclerosis experience difficulties with risk adjustment (gauging risk and adapting accordingly) and in the speed of making decisions but not in impulsivity. These problems were seen in those classified as having cognitive impairment and those not (i.e. cognitively unimpaired). We found that decision-making impairments were twice as common in people with relapsing-remitting and primary progressive MS than healthy controls, and almost four times as common in people with secondary progressive multiple sclerosis. In addition, decision making impairments in multiple sclerosis were linked to MRI changes in regions previously linked to decision-making in other conditions, including fronto-striatal and hippocampal regions. These findings offer insight into the precise decision-making difficulties experienced by people with multiple sclerosis, the relative prevalences in different subtypes of the disease and the pathological processes that may underlie them.

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Multiple Sclerosis: Monoclonal Antibody Tysabri Reduces Brain Inflammation

Jeppe Romme Christensen  MD PhD From the Danish Multiple Sclerosis Center Copenhagen University Hospital Hvidovre, Denmark.MedicalResearch.com Interview with:
Jeppe Romme Christensen  MD PhD
From the Danish Multiple Sclerosis Center
Copenhagen University Hospital Hvidovre, Denmark.

MedicalResearch.com: What are the main findings of the study?

Dr. Christensen: This study demonstrates that progressive multiple sclerosis (MS) patients have reduced inflammation and tissue damage in the brain after treatment with natalizumab. These findings highlight that progressive MS is an inflammatory disease and furthermore that peripheral circulating immune cells contribute to brain inflammation and tissue damage in progressive MS.

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MS Progression: Cannabis Active Ingredient Ineffective

Professor John Zajicek Professor of Clinical Neuroscience, Centre for Clinical Trials & Health Research - Translational & Stratified Medicine (Peninsula Schools of Medicine and DentistrMedicalResearch.com Interview with:
Professor John Zajicek
Professor of Clinical Neuroscience, Centre for Clinical Trials & Health Research – Translational & Stratified Medicine (Peninsula Schools of Medicine and Dentistry)

MedicalResearch.com: What are the main findings of the study?

Prof. Zajicek: Our study investigated whether dronabinol (one of the major active ingredients of cannabis) may slow the progression of multiple sclerosis. We currently have no treatments that are effective in modifying the disease course in people with either primary or secondary MS. We did a clinical trial across the UK involving nearly 500 patients, who were randomly allocated to dronabinol or placebo, and followed them up for three years to look at progression on rates. Overall we failed to find an effect of dronabinol on disease progression,  either clinically (using a variety of clinical measures) or using magnetic resonance imaging (MRI). There was a suggestion of an effect in people with the least disability (who didn’t need a stick to help them walk), and there were no major problems with serious side effects.  However, over all the population that took part in the study also progressed less than we expected, which reduced our chances of finding an effect of treatment. The  study was not designed to investigate an effect on MS-related symptoms (such as pain and muscle stiffness), which have been investigated before.
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Incidence of multiple sclerosis in multiple racial and ethnic groups

MedicalResearch.com eInterview with Annette Langer-Gould, MD, PhD

From the Department of Research and Evaluation Kaiser Permanente,
Southern California, Pasadena; and Neurology Department
Kaiser Permanente, Southern California Los Angeles Medical Center, CA.

MedicalResearch.com: What are the main findings of the study?

Dr. Langer-Gould: The main findings of the study were that multiple sclerosis is more common in black women than in white women, which run contrary to the widely accepted belief that blacks are less susceptible to MS. In particular, we found that black patients had a 47 percent higher risk of MS than white patients, while Hispanic and Asian patients had a 50 percent and 80 percent lower risk compared to white patients, respectively. We also found that 70 percent of MS cases occurred in females, but this preponderance of females diagnosed was more pronounced among black patients than white patients. In addition, black women had a higher incidence of MS than white patients of both genders, while black men had a similar risk of being diagnosed with MS compared to white men. The lower risk among Hispanic and Asian patients was true for both sexes.
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New Multiple Sclerosis Gene Associations Discovered

An international team of scientists has identified 29 new genetic variants linked to multiple sclerosis, providing key insights into the biology of an important and very debilitating neurological disease.

Multiple sclerosis (MS), one of the most common neurological conditions among young adults, affects around 2.5 million individuals worldwide. It is a chronic disease that attacks the central nervous system (CNS), which includes the brain, spinal cord and optic nerves, and can cause severe symptoms such as paralysis or loss of vision.

Vanderbilt University Medical Center’s Center for Human Genetics Research (CHGR) played an important role in the research published today in the journal Nature, which represents the largest MS genetics study ever undertaken and effectively doubles the number of genes known to be associated with the disease.

“We now know just how complex multiple sclerosis is,” said Jonathan Haines, Ph.D., director of the CHGR and one of the principal researchers in this effort. “These new genes give us many new clues as to what is happening in MS and will guide our research efforts for years to come.”

Researchers studied the DNA from 9,772 individuals with multiple sclerosis and 17,376 unrelated healthy controls. They were able to confirm 23 previously known genetic associations and identified a further 29 new genetic variants (and an additional five that are strongly suspected) conferring susceptibility to the disease.

Many genes implicated in the study are relevant to the immune system, shedding light onto the immunological pathways that underlie the development of multiple sclerosis.

One-third of the genes identified in the study have previously been implicated in playing a role in other autoimmune diseases such as Crohn’s Disease and Type 1 diabetes, Haines said.

Previous studies have also suggested a link between vitamin D deficiency and an increased risk of multiple sclerosis; researchers in this study identified two genes involved in the metabolism of vitamin D, providing additional insight into a possible link between genetic and environmental risk factors.

The international team led by the Universities of Cambridge and Oxford, and funded by the Wellcome Trust, includes contributions from nearly 250 researchers as members of the International Multiple Sclerosis Genetics Consortium and the Wellcome Trust Case Control Consortium.