Research news
Open Door - February 2009 pages 4-5
- Fingolimod (FTY720) trial results
- BG12 (oral fumarate) reduces relapse rate
- Sunlight and MS
- Head injuries do not lead to the onset of MS
- MS services inadequate and inconsistent
- MS in south east Wales
- Men are white, women are grey
- Cladribine trial results
Fingolimod (FTY720) trial results
New research suggests that fingolimod (FTY720), an experimental oral drug for MS, may be more effective than current treatments.
The trial, the first of three studies of fingolimod to report, was a one year study involving 1,292 people with relapsing remitting MS receiving either 0.5mg or 1.25mg fingolimod or beta interferon 1a (Avonex). During the study, people receiving beta interferon experienced on average 0.33 relapses. People on the lower dose of fingolimod experienced 0.16 relapses (a reduction of 52%) and those on the higher dose 0.20 relapses (a 38% reduction).
The study data is still being analysed. Novartis, the manufacturers, plan to present the results at the American Academy of Neurology conference in April and hope to submit the drug for licensing by the end of the year. NICE has already announced that it may include fingolimod in its next round of appraisals.
Further phase III trials of fingolimod are planned including a study looking at its role in primary progressive MS as a neuroprotective treatment.
Novartis press release
BG12 (oral fumarate) reduces relapse rate
A study of the oral drug BG12 found that it reduced the relapse rate and the number of new lesions seen on the MRI scans of people with MS. In this phase II study, 257 people with relapsing remitting MS received one of three doses of the drug or an inactive placebo for 24 weeks. The group receiving the highest dose of BG12 had 32% fewer relapses than the placebo group and 69% fewer lesions. Adverse events included abdominal pain and hot flushes. People on the higher doses of the drug were also more likely to experience headaches and fatigue. These results suggest that larger phase III studies are warranted.
Kappos L, et al.
Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study.
Lancet 2008; 372(9648):1463-1472.
Sunlight and MS
A study in Tasmania examined the association between ultraviolet radiation from sunlight, blood levels of vitamin D (created by the skin in response to exposure to sunlight) and the impact of upper respiratory tract infections with relapse rates. 142 people with relapsing/ remitting MS were studied over an average of 2.3 years. The lowest relapse rate was recorded during February (towards the end of the Australian summer), and seemed to lag a month and half behind the period of highest exposure to sunlight, suggesting sunlight has some limiting effect on relapse rates. Upper respiratory tract infections were associated with a higher number of relapses.
Tremlett H, et al.
Monthly ambient sunlight, infections and relapse rates in multiple sclerosis.
Neuroepidemiology 2008; 31(4):271-279.
Head injuries do not lead to the onset of MS
Whether or not physical trauma leads to the onset of MS has long been a point of debate. In this Danish study, researchers identified 150,868 people aged under 55 who had had hospital treatment for a head injury between 1977 and 1992 and matched them with the register of people who were diagnosed with MS up to the end of 1999. The proportion of people who had developed MS following a head injury was similar to that expected in the general population. This was found to be the case regardless of the level of severity of the trauma suggesting that head injury does not affect the risk of acquiring MS later in life.
Pfleger C, et al.
Head injury is not a risk factor for multiple sclerosis: a prospective cohort study.
Multiple Sclerosis 2009;15(3):294-298.
MS services inadequate and inconsistent
In a comment article in the Lancet, Professor Alan Thompson of the Institute of Neurology used the launch of the MS Atlas to review the management of MS.
The MS Atlas was published by the World Health Organisation and the Multiple Sclerosis International Federation in September. It gathers data on the prevalence of MS and access to health services and treatment from 112 countries.
Recognising the wide variation in services, Professor Thompson drew attention to the fact that no country provides an adequate, joined-up service across the spectrum of care required by people with MS. He noted that people with MS rated access to information about their condition as one of their biggest problems, but also the importance of employment and the need to be supported in the workplace.
The MS Atlas reflects work by the European MS Platform which reported a wide variation in service provision across Europe. It also backs up the audit of services in the UK by the Royal College of Physicians and the MS Trust which found problems with service provision, coordination, and responsiveness.
Professor Thompson challenges his colleagues that, "At a time when MS is deemed to be a treatable, manageable condition - albeit a challenging one - it is essential that we use the MS Atlas to its maximum potential to redress the inadequate and inconsistent services available for people with MS worldwide."
Thompson AJ.
Multiple sclerosis-a global disorder and still poorly managed.
Lancet Neurology 2008; 7(12):1078-1079.
- More on the audit of services by the Royal College of Physicians and the MS Trust
- Map of MS services in the UK
MS in south east Wales
Studies of the distribution of MS (epidemiology) suggest that there is an increasing number of people with the condition, particularly women. To test this, researchers resurveyed MS in Cardiff and the Vale of Glamorgan, an area previously surveyed in the 1980s.
The results showed that prevalence of MS had risen by 45% from 101 to 146 cases per 100,000. There was a marked increase in the number of women being diagnosed, from 2.65 to 7.30/100,000/year, which had increased the ratio of women to men with MS from 1.8 to 4.3.
As there was no indication that MS was developing or being diagnosed at an earlier age, the researchers suggest that the changing pattern may be the result of environmental or lifestyle factors that affect women. However, further studies are needed to identify what these factors might be and if they might be avoidable.
Hirst C, et al.
Increasing prevalence and incidence of multiple sclerosis in south east Wales.
Journal of Neurology, Neurosurgery and Psychiatry 2009;80(4):386-391.
Men are white, women are grey
To explore gender differences in MS, researchers examined MRI scans of 595 women and 168 men with MS. MS is known to lead to atrophy, the shrinking in the volume of the central nervous system (the brain and spinal cord). Regardless of the type of MS, men tended to a higher level of atrophy than women and to have a lower volume of grey matter - that part of the tissue of the central nervous system made up of the bodies of nerve cells. Women tended to show a lower volume of white matter - tissue made up of the nerve cell extensions (axons) which are covered in myelin. The researchers suggest that these differences may be due to the effect of sex hormones on brain damage and repair mechanisms.
Antulov R, et al.
Gender-related differences in MS: a study of conventional and nonconventional MRI measures.
Multiple Sclerosis 2009;15(3):345-354.
Cladribine trial results
Cladribine, an experimental oral drug, is effective in reducing the number of relapses experienced according to new research.
The CLARITY trial, was a two year study involving 1,326 people with relapsing remitting MS receiving one of two doses of cladribine or an inactive placebo. People receiving the lower dose experienced a 58% reduction in relapse rates compared to the placebo group (an average of 0.14 relapses compared to 0.33). Side effects included a reduction in white blood cells (lymphopenia), headaches and cold symptoms.
Detailed results from the study will be presented at conferences in 2009 and the manufacturers, Merck Serono, hope to submit the drug for licensing during the year. The National Institute for Health and Clinical Excellence (NICE) have already suggested that they may include cladribine in their next round of assessments.
Merck Serono press release
Join the Open Door mailing list to receive your own copy through the post (UK addresses only) or by email.
- Articles in the current issue
- Vitamin D and MS
- The nice things in life
- Staying smart and staying afloat
- Fatigue management in MS
- Standing up for MS
Disclaimer
Open Door 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.
