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A million-dollar study to evaluate MS drug safety and effectiveness
There are more than ten different drug therapies approved in Canada to treat multiple sclerosis (MS), but what do we know about their long-term value? With a $1.2 million endorsement from CIHR, Dr. Helen Tremlett, Canada Research Chair in Neuroepidemiology and Multiple Sclerosis and her team, will determine the safety and effectiveness of commonly prescribed MS drugs.
More than 90,000 Canadians live with MS, a chronic disease affecting the brain and central nervous system. It often affects young adults, with diagnosis generally occurring between 25 and 45 years of age. Canada has some of the highest known rates of MS in the world.
For Dr. Tremlett, who is the Principal Investigator of the Pharmacoepidemiology in Multiple Sclerosis Research Group, the study is a massive undertaking involving collaborators from across Canada. The results of the study will inform better clinical decision-making, and ultimately improve outcomes related to treatment and health-related quality of life of people living with MS.
“There has never been a study like this,” says Dr. Tremlett. “This is bigger and more comprehensive than anything done before, and we hope findings will have a positive long term impact on Canadians living with MS.”
Using clinical and health administrative data spanning two decades from multiple provinces including information collated from physician, hospital and pharmacy visits, including prescriptions filled, Dr. Tremlett and her team will assess whether each drug is linked with potential adverse effects, or positive outcomes such as fewer hospitalizations, lower disability rates or a prolonged life expectancy. The research is independent of the drug manufacturers, and capitalizes on the rich health data available in Canada to paint a complete picture of each drug’s long-term safety and effectiveness.
“The benefit to using this type of health administrative data is that it’s inclusive and population-based. For example, we will capture populations who are often excluded from clinical drug trials, such as older adults with MS, people with MS in poorer communities, and those with co-existing medical conditions,” says Dr. Tremlett.
The drugs approved to treat MS are known to be efficacious, as shown in short term clinical trials in select groups of individuals followed very carefully over just two to three years. However, little is known about how these MS drugs impact the wider MS population, when used in clinical practice over longer periods of time.
“By accessing the comprehensive and rich health data available in Canada, we will examine the relationships between the MS drugs and potential adverse effects, such as infections, cancer or stroke,” says Dr. Tremlett. “Also, we will thoroughly examine whether the MS drugs carry benefits that are not always possible to assess in short term clinical trials, such as whether the MS drugs result in fewer hospitalizations or have a positive effect on long term MS disability outcomes and life expectancy.”
The study has recently been funded by the Canadian Institutes of Health Research (PI: Helen Tremlett, University of British Columbia, Appl#388480). Dr Tremlett is funded by the Canada Research Chair Program.
Kingwell E, Zhu F, Marrie RA, Fisk JD, Wolfson C, Warren S, Profetto-McGrath J, Svenson LW, Jette N, Bhan V, Yu BN, Elliott L, Tremlett H. High incidence and increasing prevalence of multiple sclerosis in British Columbia, Canada: findings from over two decades (1991-2010). J Neurol. 2015 Oct;262(10):2352-63