Research news - April 2010
Way Ahead 2010;14(2):2
- New ABN guidelines published
- Tysabri labelling changes
- FDA approves Fampridine-SR
- Study shows season of birth affects risk of MS
- Oral treatments update
New ABN guidelines published
The new Association of British Neurologists (ABN) revised (2009) guidelines for prescribing disease modifying drugs in multiple sclerosis have been published. The original ABN guidelines were published in 2001. The revised guidelines incorporate advances in treatment. They lay out a clear strategy for treating people with MS with drug therapies that support the concept of the Department of Health Risk-sharing Scheme, and the need for people to be referred to a neurologist with special expertise in MS.
- A copy of the new guidelines can be downloaded from the ABN website (pdf 160kb)
Tysabri labelling changes
Following concerns over the safety of the drug, the European Medicines Agency conducted a review of Tysabri, and issued a series of recommendations in January 2010. The committee concluded that the risk of developing PML appears to increase after it has been taken for two years. This information will shortly be included in updated labeling information for Tysabri. In addition to the labeling changes, the committee also recommended that forms should be signed by people receiving Tysabri both at the beginning of treatment and after two years to confirm that they understand the increased risk of PML associated with longer treatment duration.
FDA approves Fampridine-SR
The US Food and Drug Administration (FDA) approved fampridine-SR - brand name Ampyra - as a treatment to improve walking ability in people with multiple sclerosis. News of the drug's approval in the US followed the recent announcement of a licence submission to the EMA, the drug licensing body in Europe.
Study shows season of birth affects risk of MS
A study published in European Neurology suggests that babies born in spring have an increased risk of developing multiple sclerosis later in life. The researchers looked at records of 1,300 people with MS born in the west of Scotland between 1922 and 1992. A much higher than expected proportion were born in March, April or May. In contrast, a lower proportion of those born in the autumn, particularly in November went on to develop MS. These findings reflect earlier studies that have drawn a connection with vitamin D levels in the mother. A principal source of vitamin D is regular exposure to sunlight. For children born in April, the last stages of the pregnancy will have coincided with the darkest months of the year.
Bayes HK, et al.
Timing of birth and risk of multiple sclerosis in the Scottish population.
Euro Neurol 2009;63(1):36-40.
abstract
Oral treatments update
The publication of positive results for the oral drugs (cladribine and fingolimod) courted significant media interest recently. The New England Journal of Medicine featured three papers reporting on two fingolimod trials and one cladribine trial.
Fingolimod (FTY720)
TRANSFORMS was a one-year, randomised, double-blind study involving 1,292 people with MS and comparing two doses of fingolimod to interferon beta-1a (Avonex). The results showed a 52% reduction in the relapse rate for people on the lower dose of FTY720 and a 38% reduction with the higher dose compared to that seen in people taking interferon beta-1a. Similarly, 80% of people taking the lower dose of fingolimod and 83% on the higher dose didn't have a relapse during the year long study compared to 69% of those on interferon beta-1a.
Data from the two-year FREEDOMS study also showed that people on fingolimod experienced fewer relapses. 1,272 people completed this study which compared two doses of fingolimod to placebo and showed that the relapse rate was reduced by 60% for people on the lower dose and 54% for the higher dose. Disability progression, as measured by the Expanded Disability Status Scale (EDSS), was reduced by 30% and 32% respectively for people taking fingolimod. The lower dose fingolimod will be used in future trials due to its better side effect profile.
Cladribine
The CLARITY trial was a two year study involving 1,326 people with relapsing remitting MS receiving one of two doses of cladribine or a placebo. During the study, people receiving the lower dose of cladribine experienced a 55% reduction in relapse rates compared to the placebo group (an average of 0.14 relapses compared to 0.33). People taking cladribine were less likely to show any progression of disability, as measured by the Expanded Disability Status Scale (EDSS) and any progression developed later than in the placebo group.
Side effects included lymphopenia (a reduction in white blood cells), headaches and nasopharyngitis (a cold).
Fingolimod was submitted to the EMA, the drug licensing body in Europe, at the end of 2009. Cladribine, was also submitted for a licence in July 2009. NICE has indicated that it will include both drugs in its next round of assessments.
Cohen J, Barkhof F, Comi G, et al.
Oral fingolimod vs intramuscular interferon in relapsing multiple sclerosis.
New Engl J Med 2010;362(5):402-415.
abstract
Kappos L, Radue E-W, O'Connor, P et al.
A placebo-controlled study of oral fingolimod in relapsing multiple sclerosis.
New Engl J Med 2010; 362(5):387-401.
abstract
Giovannoni G, Comi G, Cook S, et al.
A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis.
New Engl J Med 2010; 362(5):416-426.
abstract
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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.
