Updated recommendations aim to give you a bigger say in how you manage your disease.
by Aviva Patz
The American Academy of Neurology (AAN) has unveiled new disease-modifying treatment guidelines for people with multiple sclerosis, the first revisions in more than 16 years.
“So much has changed about the diagnosis of MS, how we monitor treatment, and the landscape of therapy—we needed a full evaluation of all the medicines,” says Cleveland Clinic neurologist Alexander Rae-Grant, MD, lead author of the new guidelines, published in the journal Neurology. The guidelines evaluate 23 different medications, including 23 FDA-approved disease-modifying therapies and medications that are used off-label for MS.
Off-label medications are not specifically labeled by the Food and Drug Administration for treatment of MS. The new guidelines also update advice on starting, switching and stopping treatment. They consider the best treatment protocols for the various phases of MS—relapsing remitting, secondary progressive, and primary progressive, as well as clinically isolated syndrome, a precursor in many cases to MS. Lastly, the guidelines seek to give people with MS a more active role in shaping and monitoring their own course of therapy.
The new guidelines are based on findings from a systematic review and were drafted according to protocol set by the Institute of Medicine. Whether you have lived with MS for years or are newly diagnosed, the new guidelines seek to give you a bigger say in the decisions surrounding starting, switching and stopping your therapy based on your preferences, lifestyle, other existing medical conditions and your experience of how it’s working (or not), plus any side effects. Ultimately, the new guidelines should improve your care and your ability to manage your disease. “We hope it will ensure a better ongoing dialogue about the reason for the medicines, what the medicines do and don’t do, better monitoring for side effects and adherence to treatments, and a more active stance in changing to a different and potentially better medicine during the course of the condition,” Dr. Rae-Grant says. Here’s what you need to know about how they might change the way you’re managing your MS.
What you should do now
You may be tempted to ask your doctor to switch or even stop your disease-modifying therapy (DMT). However, Ruth Ann Marrie, MD, PhD, director of the Multiple Sclerosis Clinic at the University of Manitoba, suggests asking instead, “Is my current treatment regimen still the most appropriate for me?” Because, she explains, “The older medications have a good safety track record and some people respond very well to them, so newer is not necessarily better.” That said, she emphasizes that for people with MS, “every visit with their neurologist is an opportunity to review how they are doing with respect to their MS and to review their treatment plan, including whether any changes in that treatment are needed.”
The guidelines add best practices for the management of DMTs around the time of pregnancy. “Women should stop their DMT before conception for planned pregnancies unless the risk of MS activity during pregnancy outweighs the risk associated with the specific DMT during pregnancy.” Again, women should discuss their options with their neurologist.
The guidelines also recommend that doctors consider off-label use of the medications azathioprine and cladribine for people with MS who have fewer financial resources, and to also think about ways they can help their patients secure financial assistance for those medications, according to Dr. Marrie. As part of the guidelines, doctors are advised to review the risks of treatment with certain medicines, as there’s some concern about the safety profile of mitoxantrone, and other medications (natalizumab, fingolimod, rituximab, ocrelizumab, and dimethyl fumarate) may raise the risk of a progressive brain disorder to which some people with MS are vulnerable.
Although the new guidelines represent a major update for the treatment of MS, doctors still have many questions. In future research, they’d like to see more head-to-head comparisons between DMTs as well as a comparison of medications in a population of people with MS who might have other conditions complicating care, just like in real life. “There’s so much more to do in the MS field,” Dr. Rae-Grant says.
Several such comparative effectiveness studies are underway with funding from the Patient-Centered Outcomes Research Institute (PCORI).