Research news
Way Ahead 2010;14(3):2-4
- MS research showcased at AAN meeting
- Summer births and risk of MS
- Vitamin D and MS
- UK stem cell study results published
- CIS: treat all versus watch and wait
- New NICE guidance
- Tysabri labelling changes
- Sativex gets UK licence
MS research showcased at AAN meeting
The 62nd annual meeting of the American Academy of Neurology (AAN) took place in April in Toronto, Canada. The annual meeting serves as a showcase for the latest developments in scientific research, and is attended by the world's leading researchers and neurologists.
The programme offered some encouraging insight into the variety and extent of MS research. A summary of the conference highlights follows:
Tysabri and PML
Further studies demonstrated the clinical efficacy of Tysabri. In addition, focus was given to progressive multifocal leukoencephalopathy (PML), and in particular, the role played by the JC virus thought to cause PML, a rare but serious side effect of the treatment.
The drug manufacturer is seeking to develop a test that may help assess an individual's likelihood of developing PML whilst receiving Tysabri. Clinical trials of a test designed to detect JC virus are expected to get underway this year and if proven to be an effective screening tool could lead to more accurate risk versus benefit treatment decisions.
Cladribine
Consolidating the positive results that were published earlier this year, data presented at the AAN showed that 43-44% of people who received cladribine in the phase III CLARITY trial remained disease free (as defined by an absence of relapses, no disability progression and no evidence of disease activity on MRI) over the entire 96 week study. This compared with 16% of participants receiving placebo who remained disease free.
Cladribine is currently undergoing a NICE single technology appraisal process. As part of this process the MS Trust recently responded to a consultation document. The appraisal committee meeting is scheduled for 20 September 2010.
Fingolimod
Further data on fingolimod (FTY720) added to the positive results that were published earlier this year. AAN presentations demonstrated that fingolimod reduced relapses by 62% in newly treated individuals and by 44% in previously treated individuals. The drug continued to be effective over two years.
A NICE single technology appraisal has also been initiated for fingolimod.
Alemtuzumab (Campath)
Four year follow-up data from the completed phase II study comparing alemtuzumab against Rebif, was presented at the AAN. The data indicated that around 71% of people treated with alemtuzumab remained free of disease activity up to three years after their last course of treatment. Furthermore, around 91% of people receiving alemtuzumab showed no worsening of their disability compared to 68% of people taking Rebif.
Rituximab (Rituxan)
Rituximab is a monoclonal antibody licensed to treat leukaemia and non-Hodgkins lymphoma. The results of a small study presented at the AAN suggest that it may be effective in treating secondary progressive MS. Ten people with secondary progressive MS no longer experiencing relapses took part in the study. All were treated with an initial cycle of rituximab and five received a second cycle after six months. The participants who received the second cycle showed an improvement in levels of physical disability and improved times in the 25-foot walk. The researchers noted that larger scale trials are needed to confirm these positive results.
Statins
A study examining the effect of statins on the progression of MS found that the cholesterol-lowering drugs reduced the number of new brain lesions over a twelve month period. Of the 81 participants who took part in the study 55.3% of participants did not develop new brain lesions when administered statins compared with 27.6% of the placebo group. While the results of this study are encouraging, a small number of people were involved in the trial and the researchers acknowledged that further larger studies are needed to confirm these positive results.
Other research news
Summer births and risk of MS
A study published in the British Medical Journal suggests that people born in the summer months have a higher risk of developing multiple sclerosis. The study was based on the records of 1,524 people with MS born in Australia between 1920 and 1950. Researchers obtained data on month and region of birth for each individual and accounted for regional and seasonal variations when calculating their levels of exposure to ultraviolet radiation at birth. Findings from the study showed that there was a much higher number of people born in the Australian summer months of November and December compared to those born in the Australian early winter months of May and June. Interestingly, the researchers found that it was the level of exposure to sunlight during the first trimester (first three months) as opposed to the entire pregnancy duration that was responsible for modifying the risk of developing MS in offspring.
The authors of the study hypothesise that concentrations of vitamin D might be particularly important in the development of the central nervous system during the first three months of embryonic development. The findings of this study are very interesting - particularly when viewed alongside the results of a Scottish study which also indicated that month of birth influenced the risk of developing MS.
Staples J, Ponsonby A-L, Lim L, 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
Bayes HK, Weir CJ, O'Leary C.
Timing of birth and risk of multiple sclerosis in the Scottish population.
Eur Neurol 2009; 63(1):36-40.
abstract
Vitamin D and MS
An extensive review of the evidence for a role of vitamin D in preventing and treating MS was published in a recent issue of Lancet Neurology. The review discusses the findings of studies that have investigated the relationship between various measures of vitamin D: exposure to sunlight, dietary sources of vitamin D, and concentrations of vitamin D in the blood.
As well as a protective role, the authors also point to a potential role for vitamin D in modifying the course of MS - though concede that evidence for this mechanism is less compelling.
The authors call for a large-scale study to clarify the safety and effectiveness of vitamin D supplementation in preventing MS and other conditions that emerging evidence has linked to vitamin D deficiency.
An accompanying editorial echoes the call for a large-scale trial to address the many questions that remain to be answered about vitamin D supplementation.
Ascherio A, Munger KL, Simon KC.
Vitamin D and multiple sclerosis.
Lancet Neurol 2010; 9(6):599-612.
abstract
Vitamin D: hope on the horizon for MS prevention?
Lancet Neurol 2010; 9(6):555.
UK stem cell study results published
The regenerative potential of stem cells in neurological conditions such as MS has stimulated much interest in recent years. The results of a small study involving six people with MS who received bone marrow stem cell therapy were recently published. The study participants received a general anaesthetic before bone marrow was extracted. The marrow cells were filtered and prepared so that they could be re-infused later the same day. The progress of the participants was followed over the course of one year and no serious adverse effects were reported. Clinical measures also indicated that their MS was stable.
Neil Scolding, Burden Professor of Clinical Neurosciences, Bristol, and a trustee of the MS Trust, led the study. Commenting on the results he said, "We are encouraged by the results of this early study. A larger study is required to assess the effectiveness of bone marrow cellular therapy in treating MS. We are hopeful that recruitment to a phase 2/3 study may begin towards the end of this year."
Coinciding with the publication of these results, an international consensus on the future of stem cell transplantation research for people with MS was published in Nature Reviews Neurology. The guidelines were published with the aim of facilitating coordinated global research and best practice in conducting clinical trials to assess the safety and effectiveness of stem cell therapies in MS.
Rice CM, Mallam EA, Whone AL, et al.
Safety and feasibility of autologous bone marrow cellular therapy in relapsing-progressive multiple sclerosis.
Clin Pharmacol Ther 2010;87(6):679-685.
abstract
Martino G, Franklin RJM, Van Evercooren AB, et al.
Stem cell transplantation in multiple sclerosis: current status and future prospects.
Nat Rev Neurol 2010;6(5):247-255.
abstract
CIS: treat all versus watch and wait
Evidence has emerged to suggest that the earlier in the course of MS disease modifying treatment commences, the more effective it is. A number of studies have also indicated that starting disease modifying treatment after a clinically isolated syndrome (CIS) delays the onset of MS. In spite of this evidence, the use of disease modifying drug treatment after a clinically isolated syndrome remains controversial.
The counter argument to the 'treat all' approach to CIS is that this approach inevitably exposes some people who would never go on to develop MS to unnecessary treatment. A commentary recently published in the journal Multiple Sclerosis probes the issue further; reviews all existing evidence for and against initiating therapy after a clinically isolated syndrome; and summarises the key considerations for neurologists engaging in the management of people with a clinically isolated syndrome. The authors conclude by advocating an initial period of observation in all cases of CIS, allowing a 'window of opportunity' during which further prognostic indicators might emerge to support a more accurately informed decision on appropriate treatment.
Gilmore CP, Cottrell DA, Scolding NJ, et al.
A window of opportunity for no treatment in early multiple sclerosis?
Mult Scler 2010;16(6):756-759.
New NICE guidance
Treatments for neuropathic pain
The National Institute for Health and Clinical Excellence (NICE) has published a clinical guideline on the drug treatments that should be prescribed for neuropathic pain in non-specialist settings. The new guidelines set out which treatments should be prescribed for neuropathic pain associated with MS and other conditions, and in which order they should be given.
Dr Fergus Macbeth, Director of the Centre for Clinical Practice at NICE said, 'Neuropathic pain commonly occurs alongside a vast number of chronic health problems. It can be difficult to treat because it is resistant to certain medications and some of those that do work can have unpleasant side effects. This is the first time that we have published a clinical guideline in this area and so we hope it will be of great use to health professionals in these settings.'
The full guideline can be downloaded from the NICE website at the web address detailed below.
National Institute for Clinical Excellence.
Neuropathic pain: the pharmacological management of neuropathic pain in adults in non-specialist settings.
NICE clinical guideline 96. [cited May 2010]
Available from: URL: www.nice.org.uk/CG96
Male continence problems
The National Institute for Health and Clinical Excellence (NICE) has issued new guidelines which address continence symptoms commonly experienced by men.
Around a quarter of men over 40 have continence problems such as the need to urinate urgently or frequently, retention of urine, hesitancy and incontinence. Amongst men with MS the proportion is much higher. The new guidelines cover the assessment and treatment of symptoms and recognise the need to provide appropriate information and emotional support for symptoms that can have a profound impact on an individual's independence and self esteem.
The new guidelines reflect the findings of the UK consensus on the management of the bladder in multiple sclerosis. This document, which was published last year, was produced by a multidisciplinary group of specialist doctors and nurses involved in the treatment of continence symptoms.
The full guideline can be downloaded from the NICE website at the web address detailed below. The MS Trust contributed to the publication of A UK consensus on the management of the bladder in multiple sclerosis. A summary leaflet can be downloaded below.
National Institute for Clinical Excellence.
The management of lower urinary tract symptoms in men.
NICE clinical guideline 97 [cited May 2010]
Available from: URL: www.nice.org.uk/CG97
Fowler CJ, Panicker JN, Drake M, et al.
A UK consensus on the management of the bladder in multiple sclerosis.
J Neurol Neursurg Psych 2009; 80:470-477.
abstract
- UK consensus on the management of the bladder in multiple sclerosis - summary leaflet
- Bladder problems factsheet
Tysabri labelling changes
The patient information leaflet for Tysabri has been updated to include information about the increased risk of PML after two years and additional information on the management of people with signs of the potentially fatal brain infection. In view of the increased risk, the patient information leaflet states that people should be re-informed about the increased risk of PML after two years and continuation of treatment only considered after a reassessment of the benefits versus the risks of treatment.
Both the patient information leaflet and the patient alert card issued to users of Tysabri have been updated to include information about the signs of PML and IRIS (immune reconstitution inflammatory syndrome) a severe inflammatory reaction that is likely to occur following treatment for PML (and removal of Tysabri).
Sativex gets UK licence
The cannabis-based mouth spray, Sativex, has received approval from the UK drug's regulator (MHRA) as an addon treatment for MS related spasticity. Sativex receives its UK licence as an add-on treatment for moderate to severe MS spasticity in people who receive inadequate relief from the standard oral anti-spasticity medicines or have experienced unbearable side effects whilst taking these medicines.
The drug can only be prescribed by a specialist doctor with experience of treating MS spasticity such as consultant neurologists, consultant rehabilitation specialists, and consultant pain specialists. Health professionals working alongside people with MS will play an important role in ensuring the referral of appropriate individuals.
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Way Ahead articles are reproduced as published. They are not updated to take account of subsequent developments. Use appropriate caution in acting on the information in any article.
