Drug that treats infections and inflammation now recommended for delaying onset of multiple sclerosis.
About 100,000 Canadians suffer from multiple sclerosis (MS), a disease of the central nervous system. As described by the MS Society of Canada, the disease can cause symptoms such as extreme fatigue, lack of coordination, weakness, tingling, impaired sensation, vision problems, bladder problems, cognitive impairment and mood changes. Disability typically increases with the number of attacks on the nervous system.
A patient has to have two or more attacks to be diagnosed with multiple sclerosis. If they’ve just had one attack, it’s called “clinically isolated syndrome”. From 2008 through 2013, researchers with the Fraser Health MS Clinic at Burnaby Hospital helped conduct a national study of a drug, minocycline, first approved in 1969 and traditionally used to treat bacterial infections and inflammation. They tested whether it could delay the onset of MS if taken twice daily following a diagnosis of clinically isolated syndrome.
“If you delay multiple sclerosis development even by a year or two, you delay disability, and the savings for patients and the health care system can be huge,” says Dr. Galina Vorobeychik, director, Fraser Health MS Clinic and lead researcher of the clinic’s part of the study. “The lifelong cost per patient on average has been estimated at about $1.7 million with the cost per year ranging from $15,000 to well over $100,000 depending on symptoms.”
Dr. Luanne Metz, MS Program Director with the University of Calgary was the principal investigator for the national study that included patients visiting clinics in 12 cities across Canada from Burnaby to Halifax. One hundred and forty-six patients, including 19 with the Fraser Health MS Clinic, were each studied for up to two years in a double blind, randomized, placebo-controlled clinical trial funded by the Canadian Institutes of Health Research (CIHR). The trial passed a Health Canada audit “with flying colours,” says Dr. Vorobeychik, adding to the legitimacy of the results.
The study results showed the risk of having a second attack and therefore being diagnosed with MS by six months was 61.4 per cent in the placebo group and 34 per cent in the minocycline group but not over 24 months, likely due to the small number of patients. “The study showed excellent results,” says Dr. Vorobeychik “We didn’t have any significant side effects and the patients who avoided a second attack were very satisfied, very happy.
Anna Kazimirchik, nurse clinician with the Fraser Health MS Clinic, says it’s very important to have this clinical data. “We can give assurance to the patient and can use the clinical data to support why the medication is being prescribed.”
In addition to its effectiveness, minocycline offers other advantages: It’s readily available and has a decades-long safety track record. Also, it’s provided in pill form, which is much more comfortable than other drugs for patients with clinically isolated syndrome, which are only provided by injection. It’s also dramatically cheaper. “The cost of other medications is around $15,000 to $40,000 per year and the cost of this medication is less than $500 per year,” says Dr. Vorobeychik “It all has a huge impact.”
Because the drug was already approved by Health Canada, physicians in the know have been able to go ahead and prescribe it following the national wrap-up of the study in 2015. Typically, a patient who has had symptoms of clinically isolated syndrome is referred to one of the MS clinics across the country where a neurologist there can prescribe it. However, any physician who’s aware of the study results can become involved in prescribing and monitoring the use of minocycline. “I would recommend this as an option after a patient has received an initial assessment and prescription from an MS clinic,” says Dr. Vorobeychik.
To help move the research to practice, Dr. Vorobeychik has presented the study findings locally to patients in the Lower Mainland through the MS Society, and results were also presented at international conferences such as The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) with as many as 10,000 attendees. The results also were shared with Fraser Health neurologists on the Fraser Health Neurology group meeting.
The researchers have been working with the MS Society of Canada to help raise awareness among doctors and patients. They’ve also submitted a paper on the study to the peer-reviewed New England Journal of Medicine where they hope it was published in June 2017 to reach additional neurologists, family doctors and patients.
As for patients with clinically isolated syndrome who are referred to the Fraser Health MS Clinic, “We have the experience of the clinical trial, so our patients are getting first opportunities,” says Dr. Vorobeychik. “We prescribe it all the time now.”
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