People living with multiple sclerosis (MS) currently can choose from 17 disease-modifying treatments (DMTs) approved by the U.S. Food and Drug Administration (FDA).
Recommendations for starting, switching, and stopping these DMTs were announced at the 2018 American Academy of Neurology (AAN) annual meeting this week in Los Angeles.
This is the first update in 16 years. Much has changed during that time.
“The previous guideline we had was in 2002, and at that time we only had a small array of medicine for people with MS,” explained Dr. Alex Rae-Grant, fellow of the American Academy of Neurology and lead author of the new guidelines. “We now have 17 FDA-approved medicines and it’s much more complicated, but much more exciting, in terms of what we can do for people with MS.”
The panel looked at DMT recommendations for all types of MS: clinically isolated syndromes (CIS), relapsing MS (RMS), and progressive MS (PMS).
Only one of these FDA-approved DMTs is for people with PMS. The rest are designed for RMS.
A multidisciplinary panel created the new guidelines.
Using findings from a systematic review and following an Institute of Medicine-compliant process, the panel developed modified recommendations for all phases of DMTs.
Sixteen years ago, there were only injectable forms of treatments.
Today, DMTs are available in oral form, and some more aggressive treatments are delivered via transfusion.
With this variety also comes a new level of side effects and risks.
“We need to be smarter about managing side effects and risks and all these problems. It’s exciting but complicated,” Rae-Grant told Healthline. “The new guidelines are going to help personalize the decision-making.”
He further explained that it’s important to work with patients to understand their readiness for treatment as well as their concerns, their risks, and other medical conditions.
Rae-Grant said this is part of the growing movement toward shared decision-making.
“MS medications are taken long-term, are expensive, and potentially come with side effects. We need to all be in this together to figure it out,” he said.
“Some patients will want more control over their treatment decisions,” Rae-Grant added. “Others want to be told what to do.”
These guidelines are designed to help both patient and doctor make a more informed decision.
Rae-Grant said the best result will be up to the patient’s personalized needs and “not a one size fits all” approach.
Dr. Barbara Giesser, professor of clinical neurology at the David Geffen School of Medicine at the University of California Los Angeles (UCLA) and clinical director of the UCLA MS program, told Healthline, “I think these are very thoughtful, comprehensive and practical guidelines that address many specifics of the nuances of prescribing DMTs for persons with MS. I especially am enthusiastic about the recommendations that promote shared responsibility for both patients and healthcare providers in terms of education, adherence, and decision making.”
Looking at the risks
The panel also studied the risks of many DMTs.
They took a close look at the JC virus and its resulting and often deadly brain disorder, progressive multifocal leukoencephalopathy (PML).
People with MS may carry a certain biomarker that makes them vulnerable to this brain disorder, so it’s imperative to test for it.
The panel looked specifically at consulting those who are vulnerable and defined who should take certain therapies and who should not.
The guidelines “strongly recommend early treatment in people where we know they have relapsing disease and more risk of spinal cord injury, even those with a single episode.” said Rae-Grant.
“Our new guideline pushes us to treat people earlier and to monitor them more carefully for change in their condition so that we can change medicines as they need them,” he said.
Damage to the central nervous system caused by MS can’t be undone. But by starting treatment early in disease detection, Rae-Grant said, some people may be able to slow the progression, helping maintain quality of life.
“MS is a smoldering fire. Flare-ups and relapses cause new fires, but the damage has been done,” explained Dr. Jaime Imitola, director of the Progressive Multiple Sclerosis Multidisciplinary Clinic at The Ohio State University, at the 2018 AAN annual meeting.
“There is a need to educate patients,” Imitola said. “These guidelines provide a general update, but no two patients are the same.”
Starting, switching, stopping
Overall, the panel made 17 recommendations for starting DMTs, 10 on switching DMTs, and 3 on stopping DMTs.
Using the Academy of Neurology development process, the guidelines include plans for future updates.
These recommendations were derived from a variety of earlier completed clinical studies.
“But what we need is to see them in action with a variety of patients,” explained Rae-Grant, “We need to compare the effects and use of these medicines actually in the clinic. Monitor the population and find important additional information.”
“There is lots of research and [the MS scene] looks very promising,” he added.