In patients with multiple sclerosis (MS), initiation of treatment with disease modifying therapies (DMTs) should be started early, rather than letting MS run its course, according to a new guideline for the treatment of MS developed by an expert panel from the American Academy of Neurology (AAN).
The guideline was presented at the 70th AAN Annual Meeting in Los Angeles, CA, in mid-April 2018, and is endorsed by the Multiple Sclerosis Association of America and the National Multiple Sclerosis Society. It was also published online in Neurology.
“The treatment landscape for people with MS has changed dramatically over the last decade,” said lead author Alexander D. Rae-Grant, MD, professor of medicine, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, and AAN fellow. “We now have a number of disease-modifying therapies to choose from that may help treat MS by changing how the disease affects people over time by slowing the disease process.”
About 400,000 people in the United States are affected by MS, which is the leading cause of disability in young adults. Symptoms of MS can include problems with vision, muscle weakness, bladder and bowel dysfunction, tremors, coordination problems, and cognitive and emotional problems.
For the guidelines, an AAN expert multidisciplinary panel reviewed available scientific studies on the use of DMTs. The panel developed 17 recommendations on DMT initiation, 10 on switching DMT agents in patients with breakthrough disease, and 3 on stopping DMTs. The guidelines reflect the complexities of initiating, switching, or stopping DMT treatment in MS patients. In addition, DMT risks are outlined, including counseling about the risk of progressive multifocal leukoencephalopathy in patients treated with natalizumab, fingolimod, rituximab, ocrelizumab, and dimethyl fumarate.
The panel’s first recommendation (Level B, or the level at which patient counseling is encouraged) states that clinicians should counsel patients with newly diagnosed MS about DMT treatment options at a dedicated treatment visit. The panel found strong or moderate evidence to support the use of these agents for slowing certain disease processes. However, it recommended (Level B) specifically informing patients that DMTs will not improve symptoms, but rather reduce relapse and new lesion activity, which can be detected by a magnetic resonance imaging (MRI) scan.
Agents found to have strong evidence for lowering MS relapse rates included alemtuzumab, cladribine, dimethyl fumarate, fingolimod, glatiramer acetate, interferon beta-1a, mitoxantrone, natalizumab, ocrelizumab, pegylated interferon, and teriflunomide. All of these agents have serious side effects that must be discussed.
The guidelines recommend (Level B) that clinicians monitor disease activity with an MRI scan to ascertain the formation of new lesions. Relapse and/or new lesions may develop in patients even after treatment initiation. In patients in whom disease activity resumes after taking these agents, switching to another drug may reduce their risk for continued disease activity. The recommendation (Level B) is for clinicians to evaluate the degree of disease activity, patient adherence to treatment, adverse event profile, and mechanism of action of DMTs.
The expert panel recommended caution when considering treatment discontinuation in patients with stable MS. Few studies have documented the effects of treatment discontinuation. The guideline’s Level B recommendations for these patients state that clinicians should encourage continuation of the current DMT. If a decision to stop therapy is reached, clinicians should stress the need for continued follow-up and re-evaluations of the patient.
The risks of DMTs should also be discussed, including possible effects on the reproductive health of men and women. Clinicians must carefully weigh the risk/benefit ratio with their patients when making any decision to initiate, switch, or stop DMTs.
For a copy of the guideline, “Practice Guideline Recommendations Summary: Disease-modifying Therapies for Adults with Multiple Sclerosis,” go to https://www.aan.com/Guidelines/home/GuidelineDetail/898