How safe are new disease modifying drugs in the treatment of multiple sclerosis?
Multiple Sclerosis (MS) is a chronic disease of the brain and spinal cord often affecting young adults. Injectable disease modifying drugs (DMDs) to treat MS were introduced in Canada in 1995. In recent years, three new oral DMDs have been approved by Health Canada to treat MS, with two of them approved as first-line therapies.
“As with most drugs, the new oral drugs for MS were approved based on randomized controlled trials (RCTs). However, these RCTs only last 2-3 years and typically enroll highly-motivated patients who are likely to adhere to drug treatment and other aspects of the study protocol, such as the rigorous laboratory (blood and urine) testing schedule,” says Helen Tremlett, a Professor of Neurology in the University of British Columbia’s Faculty of Medicine. “However, individuals enrolled in RCTs do not always represent people treated in the ‘real world’ clinical practice setting. In addition, people with MS may be expected to stay on treatment for much longer than 2-3 years.”
Data access has been approved for a study, the first of its kind, which will assess the uptake of these new oral DMDs, and the incidence of adverse events and adherence to the recommended safety monitoring (blood and urine tests) among the individuals with MS who are taking these drugs. The study is funded by the Multiple Sclerosis Society of Canada.
Professor Tremlett believes that the study is timely and will significantly contribute to an understanding of the use and safety of these new oral drugs for MS as they gain popularity in Canada, and ultimately, will help to pave the way towards improved health outcomes for those with MS.
For this project, PopData will link data from the BC Ministry of Health, BC Vital Statistics, PharmaNet, the BC health authorities and LifeLabs Medical Laboratory Services.
Collaborators on the study include investigators from: the University of British Columbia (Drs Elaine Kingwell, Robert Carruthers, Tingting Zhang, Feng Zhu); the University of Manitoba (Dr Ruth Ann Marrie); the University of Saskatchewan (Dr Charity Evans).