MS research update - 25 June 2010
- Monitoring safety and effectiveness of natalizumab (Tysabri)
- Adherence to self-administered disease modifying drug treatments
Monitoring safety and effectiveness of natalizumab (Tysabri)
Natalizumab (Tysabri) is a disease modifying drug licensed for use in people with highly active relapsing remitting multiple sclerosis (two or more disabling relapses in one year). Studies have shown natalizumab to reduce the occurrence of relapse by around two thirds and significantly reduce the rate of disease progression.
A serious side effect that was seen during clinical trials of the drug is a potentially fatal brain infection, progressive multifocal leukoencephalopathy (PML). This Swedish study has monitored the safety and effectiveness of the drug in people with MS since its launch in Sweden in 2006 up until January 2010.
1,115 people with MS were included in the study, 363 of whom had received natalizumab for longer than two years. Over the study period, 10% of people stopped using the drug, mainly due to planned pregnancy. Serious side effects were rare but three cases of PML were recorded. People who received treatment for longer than two years showed significant improvements in their levels of disability when compared to pre-treatment levels.
The authors conclude the natalizumab is very effective for people with aggressive forms of MS and it is generally well tolerated. The authors acknowledge that the risk of PML remains a concern.
Piehl F, Holmen C, Hillert J, et al.
Swedish natalizumab (Tysabri) multiple sclerosis surveillance study
Neurological Sciences 2010 [Epub ahead of print]
Medline abstract
Adherence to self-administered disease modifying drug treatments
In order to reap the full benefits of self-administered disease modifying treatments for MS they must be taken over a period of time. For this reason, adherence to prescribed drug treatments is important.
This study used questionnaires to investigate disease modifying drug treatment adherence among people with relapsing remitting MS. 2,648 people completed the questionnaire with an average treatment duration of 31 months. The questionnaire data revealed that 75% of people were adherent to drug treatment. The most common reasons for non-adherence were forgetting to administer the injection (50%) and other injection-related reasons (32%). Further findings included a trend for treatment adherent people to have had a shorter disease and treatment duration and greater adherence among women than men.
The paper suggests that understanding the reasons behind non-adherence to prescribed disease modifying treatments is the key to improving adherence and maximising the benefits these treatments have to offer.
Devonshire V, Lapierre Y, Macdonell R, et al.
The global adherence project (GAP): a multicentre study on adherence to disease-modifying therapies in patients with relapsing remitting multiple sclerosis.
European Journal of Neurology 2010 [Epub ahead of print]
Medline abstract