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Open Door - August 2010 pages 4-5

Understanding what causes MS
Do relapses lead to permanent disability?
New treatments, new combinations tested
UK phase I stem cell study results published

Understanding what causes MS

Identical twins study

Identical twins are of interest to researchers studying the contributions of genetics and environment to disease. This study focused on three pairs of identical twins, in which one twin had MS and the other did not. Using the latest techniques to carry out a very detailed search, the researchers could find no genetic source for differences which could explain why one twin had developed MS while the other had not.

Baranzini SE, et al.
Genome, epigenome and RNA sequences of monozygotic twins discordant for multiple sclerosis.
Nature 2010;464:1351-1356.
abstract

Vitamin D for MS prevention?

An editorial in Lancet Neurology discusses the potential for vitamin D supplements to reduce the risk of developing multiple sclerosis. The article concludes that trials are needed to address the many uncertainties that remain. Because any benefits for MS could take decades to emerge, a long-term outlook is needed from policy makers.

An extensive review of the evidence for a role of vitamin D in preventing and for treating MS is also published in this issue.

Vitamin D: hope on the horizon for MS prevention?
Lancet Neurology 2010;9(6):555.

Ascherio A, et al.
Vitamin D and multiple sclerosis.
Lancet Neurology 2010;9(6):599-612.
abstract

Sunlight and MS

In an Australian study, data gathered from 1,524 people with MS revealed an increased risk of developing MS for babies born in the summer, which the researchers linked to low sunlight exposure during the first three months of pregnancy. Low sunlight exposure may lead to low levels of maternal vitamin D at important stages of foetal development.

Staples J, et al.
Low maternal exposure to ultraviolet radiation in pregnancy, month of birth, and risk of multiple sclerosis in offspring: longitudinal analysis.
BMJ 2010;340:c1640.
read online

Using an animal model of MS, researchers have found that ultraviolet radiation dramatically suppressed the signs of MS. Only low, short-term changes in vitamin D levels were found which were considered insufficient to account for the effects of UV radiation. The authors conclude that UV radiation may have a direct effect in reducing MS-like symptoms, independent of vitamin D production, in this animal model.

Becklund BR, et al.
UV radiation suppresses experimental autoimmune encephalomyelitis independent of vitamin D production.
Proceedings of the National Academy of Science 2010;107(14):6418-6423.
abstract

A separate study has reviewed recent research and proposed alternative mechanisms for the effect of sunlight on MS with particular focus on how sunlight modifies the antigens that trigger the autoimmune response in MS and how it may influence levels of other hormones.

Mehta BK.
New hypotheses on sunlight and the geographic variability of multiple sclerosis prevalence.
Journal of the Neurological Sciences 2010; 292(1-2):5-10.
abstract

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Do relapses lead to permanent disability?

An understandable concern for people with relapsing remitting MS is that a severe relapse will leave them with permanent disability. This study investigated how often people experienced relapses that left them with significant disability, defined as an EDSS score of 6 and above (a standard measure of disability, level 6 indicates a walking aid is required) for a period of six months or longer.

Records of 1,078 people with relapsing remitting MS held by a US-based MS centre uncovered 2,587 relapses. Only seven people had a relapse that resulted in sudden onset of severe disability from which they did not recover. Two of these severe attacks occurred in people who were taking disease modifying drugs, three in people who were not and two occurred at onset of MS.

The researchers conclude that fear of severe relapses should not influence decisions to delay starting treatment or to stop treatment as such attacks are very rare and can occur whether or not people are being treated with beta interferon.

Bejaoui K, et al.
What is the risk of permanent disability from a multiple sclerosis relapse?
Neurology 2010;74(11):900-902.
abstract

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New treatments, new combinations tested

Results of a number of small studies investigating different treatments have recently been published. Here's a round-up.

Combination studies:

  • Daclizumab is licensed for treating kidney transplant rejection and interacts with a number of cells in the immune system. The combination of daclizumab and beta interferon was significantly more effective than beta interferon alone.1
  • Rituximab is licensed to treat leukaemia and non- Hodgkins lymphoma. It is known to reduce the number of B-cells in the immune system and is being studied as a treatment for MS. Rituximab was added to standard disease modifying treatments in people whose MS was not adequately controlled. Based on MRI results, rituximab add-on therapy was effective.2
  • Methylprednisolone is a steroid typically given either as tablets or infusion to speed up recovery from a relapse. Monthly pulses of methylprednisolone added to interferon beta-1a do not appear to affect disability progression any more than interferon treatment alone.3

In a review of combination therapies for MS, the authors note that although small preliminary studies suggested that combination treatment was safe, effective and with minimal side effects, subsequent larger studies have failed to support these initial findings. They conclude that although combination therapy remains an attractive option, its use has not yet been convincingly proven in MS, and there are several key unanswered questions.4

Neuroprotection in progressive MS

  • Animal studies have indicated that lamotrigine, an anticonvulsant drug that acts by blocking sodium channels, might have a neuroprotective effect. Brain volume measures of participants with secondary progressive MS treated with lamotrigine did not differ from those treated with placebo over the 24 month study. The participants had been diagnosed with MS for 18 years or more; an accompanying editorial suggests that neuroprotective treatments should be tested earlier in the course of MS.5
  • Methotrexate is an immunosuppressant drug used in the treatment of cancer, arthritis and psoriasis. Intrathecal (an injection into the spinal canal) methotrexate, given to people with secondary or primary progressive MS, resulted in stable or improved EDSS scores measured one year after last treatment.6
  1. Wynn D, et al.
    Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta.
    Lancet Neurology 2010;9(4):381-390.
    abstract
  2. Naismith RT, et al.
    Rituximab add-on therapy for breakthrough relapsing multiple sclerosis: A 52-week phase II trial.
    Neurology 2010;74(23)1860-1867.
    abstract
  3. Ravnborg M, et al.
    Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial.
    Lancet Neurology 2010;9(7):672-680.
    abstract
  4. Conway D, et al.
    Combination therapy in multiple sclerosis.
    Lancet Neurology 2010;9(3):299-308.
    abstract
  5. Kapoor R, et al.
    Lamotrigine for neuroprotection in secondary progressive multiple sclerosis: a randomised, double-blind, placebo-controlled, parallel-group trial.
    Lancet Neurology 2010;9(7):681-688.
    abstract
  6. Sadiq SA, et al.
    Intrathecal methotrexate treatment in multiple sclerosis.
    Journal of Neurology 2010 June 10 [Epub ahead of print].
    abstract

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UK phase I stem cell study results published

Researchers in Bristol have assessed the safety and feasibility of treating six people with stem cells derived from their own bone marrow. In contrast to previous studies, stem cells were not pre-treated to increase certain subsets of cells and participants did not receive treatments to suppress their immune system before their bone marrow stem cells were infused.

Participants were followed up for a year and no serious adverse effects were found. Clinical measures indicated that their MS was stable. The Bristol team were encouraged by the results which now need to be investigated further in a phase II/III clinical trial with a longer follow up period.

Rice CM, et al.
Safety and feasibility of autologous bone marrow cellular therapy in relapsing-progressive multiple sclerosis.
Clinical Pharmacology and Therapeutics 2010;87(6):679-685.
abstract

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