A Canadian clinical trial shows that minocycline, a common acne medication, can help slow the progress of relapse-remitting of multiple sclerosis.
A clinical trial led by researchers at the University of Calgary and supported by several other Canadian institutions, including the University of Alberta, shows that minocycline, a common acne medication, can slow the progress of relapsing-remitting multiple sclerosis (MS) in people who have recently experienced their first symptoms.
In addition to being an unexpected discovery-an acne drug benefitting a neurological disorder-the finding is significant as it offers a safe and affordable treatment option for those with early onset MS. This discovery could impact thousands of newly diagnosed MS patients around the world.
The results of the Phase III clinical trial were published today in the New England Journal of Medicine. The trial included 142 participants between the ages of 18 and 60, across 12 Canadian sites including Vancouver, Burnaby, Calgary, Edmonton, Winnipeg, Ottawa, Toronto, London, Montreal, Quebec City and Halifax.
MS is thought to be an autoimmune disease of the central nervous system (brain, spinal cord). The disease attacks myelin, the protective covering of the nerves, often causing inflammation and damage. The drug works by reducing the inflammation.
In Canada, the cost of current therapies for relapsing-remitting MS typically falls in the range of $20,000 to $40,000 per year; the minocycline treatment would cost a fraction of that at about $600 per year. In the United States, MS treatment often costs about three times as much as in Canada. Researchers say the potential cost savings will be tremendous and will improve access to treatment for people with MS.
Researchers and doctors are excited about the discovery, as there are no oral therapies approved in Canada for use at this very early stage of the disease.
The drug itself has been around for 50 years, and it doesn't need further Health Canada approval to be used as an off-label prescription for MS.
"The clinical results are compelling," says Hotchkiss Brain Institute (HBI) member Luanne Metz, the study's lead author, who is also a professor in the Department of Clinical Neurosciences at the University of Calgary and an Alberta Health Services neurologist. "Based on these findings, neurologists will be able to prescribe minocycline for people experiencing their first symptoms of demyelination if an MRI suggests the cause will likely prove to be MS."
"Patients will now have yet another treatment option, one that does not require injections, monitoring lab work, or special authorization by their insurance company provided they have adequate coverage to begin with. These processes can delay treatment initiation for three to four months whereas minocycline can be started immediately."
Current care for many individuals experiencing a first clinical attack suggestive of relapsing-remitting MS involves a brain MRI at about six months to determine if MS can be confirmed, or treatment with injectable medications to reduce the chance that their condition will evolve to confirm MS.
"We have not cured MS, but this trial makes future treatment easy and affordable. It has global impact because there are countries where people with MS cannot be treated because of the very high cost," says V. Wee Yong, PhD, a study author from the HBI and professor in the U of C's Department of Clinical Neurosciences.
"Minocycline is an old medication, so its long-term use and safety is well known," adds Gregg Blevins, study co-author and associate professor of medicine at the University of Alberta. "The study shows the effectiveness of the drug and that it can be part of the discussion between patients and doctors who treat people affected by Multiple Sclerosis."
Jill, 34, experienced her first sign that she could be developing MS at 27. She woke up with tingling in her hand, and the numbness spread to 50 per cent of her body before she received confirmation that lesions had formed on her brain and spine. She volunteered for the two-year clinical trial and kept taking the drug after the trial ended. "Joining the trial was an easy decision and the support I received throughout the process was excellent. I believe in research. How else are we going to learn?"
Jill is now symptom-free and not been diagnosed with MS. After being on the drug for six years, Jill consulted with her physician and decided to stop taking the medication. "It is an antibiotic, and I wanted to give my body a break from all medication. I may go back on minocycline at some point. It's great to have this option."
The trial was funded by the Multiple Sclerosis Society of Canada and its affiliated Multiple Sclerosis Scientific Research Foundation (MSSRF). Participants in the trial who were experiencing their first demyelinating symptoms were randomized to receive 100 mg twice daily of the oral minocycline or placebo. Over six months of treatment, there was a 27.6 per cent reduction of becoming full-blown MS (The risk was 61 per cent in the placebo group and 33.4 per cent in the minocycline group). This is similar to the effects of current therapies.
"This is truly a Canadian success story in research that the MS Society of Canada and MSSRF are proud to be a part of," says Karen Lee, vice president of research at the MS Society of Canada. "These are some of the world's most experienced researchers and neurologists, who have taken an idea and brought it from bench to bedside. We are very encouraged by the results of the clinical trial and pleased that people living with MS will be provided a safe and beneficial treatment option as early in the disease as possible."
This remarkable outcome for individuals experiencing demyelinating symptoms worldwide has been over 18 years in the making. Yong, a neuroscientist, initially had the idea to test the acne medicine in an animal model since minocycline has many anti-inflammatory properties that he thought could be useful in treating MS. Soon after obtaining successful research results in studies also supported by the MS Society of Canada and MSSRF, Yong teamed up with Metz who led the transition into a pilot clinical trial, then a Phase II, and finally the definitive Phase III trial.
"This study highlights the benefits of evaluating existing therapies for other indications. Minocycline is an existing acne medication which is safe, and well-tolerated and it is available for immediate clinical use," says Manitoba neurologist Ruth Ann Marrie.
The early stages of this work were supported by the Canadian Institutes of Health Research (CIHR) and community support. The clinical trial was supported by Multiple Sclerosis Society of Canada and the Multiple Sclerosis Scientific Research Foundation (MSSRF).