Assessing safety monitoring in patients taking oral multiple sclerosis treatments [ASYMPTOTE]

Principal Investigator: Dr. Helen Tremlett

Affiliation: The University of British Columbia

Term: April 1, 2015 – March 31, 2019

Funding: $286,694

Keywords: adverse events, safety, oral disease-modifying therapies, adherence

Summary:

  • Disease-modifying therapies (DMTs) that were given by injection first became available for people with multiple sclerosis (MS). More recently, DMTs that are given by mouth have entered the market.
  • Although these oral drugs provide more choice for people with MS, concerns over their safety have been raised and regular blood and urine testing is required.
  • The research team will:
    • Describe the uptake and use of these new oral drugs, evaluate their safety, determine whether people with MS take the drugs as prescribed, and assess whether the blood and urine tests are completed as often as recommended.

Project Description:

In the last five years, three oral disease-modifying therapies (DMTs) have been approved to treat MS. To date, there have been no population-based studies in Canada examining the safety of these drugs, nor has there been research tracking how well people living with MS adhere to these drugs. Dr. Helen Tremlett and her team will use a combination of health administrative data, prescription information, and laboratory test results to analyze safety and adherence information for fingolimod (Gilenya), dimethyl fumarate (Tecfidera) and teriflunomide (Aubagio) in people living with MS from British Columbia, Saskatchewan and Manitoba. The research team has discovered that uptake and use of fingolimod, dimethyl fumarate, and teriflunomide increased substantially over the first 2 to 5 years after their introduction, whereas the use of beta-interferon and glatiramer acetate decreased over the same time period. Furthermore, approximately 90% of people who started an oral DMTs continued to take it for at least 6 months, and approximately 80% continued on the drug for at least a year. This study is essential for gaining an initial understanding of the current use of oral therapies for MS and early signs of risk so that clinicians can make evidence-informed decisions about the treatment management plans for people living with MS.

Potential Impact: This examination of drug utilization, early safety signals, rates of adherence to the oral drugs and adherence to recommended laboratory tests is important, not only to gain an initial understanding of the use of these oral DMTs for MS but to help improve outcomes for those with MS.

Project Status: In Progress

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