A new study evaluates the risk of recurrence of active disease in older patients with multiple sclerosis after discontinuing disease-modifying therapies. The researchers said the findings will aid decision-making when healthcare providers and people with MS discuss potential DMT discontinuation as patients age.

Multiple sclerosis is a chronic illness, often with symptoms appearing in young adulthood. Most commonly, at onset, individuals have acute attacks, or relapses, of intermittent new neurological symptoms such as vision changes, numbness, and weakness. These may come and go, seemingly randomly, and then remit completely or incompletely. These are linked to MRI changes in the brain or spine. As people age, new attacks and MRI changes become less common, and patients either stabilize, or they may go into a phase of slow progressive neurological disability with minimal MRI changes.

There is no cure for MS, but there are now more than 20 DMTs that may substantially diminish the risks of new attacks and MRI changes. Most of the DMTs have been approved after studying only patients 55 and under. These medications appear to have greatest effect on younger patients with recent relapses, and modest effects on slowing progressive disability, especially in older patients. Thus, benefits in older patients remain unclear, while risks related to the DMTs may increase with age. Whether it is reasonable to stop using the DMTs as people age remains an important, unanswered question. 

University of Colorado School of Medicine researchers report the results of the first randomized, controlled, observer-blinded clinical trial of discontinuation of MS DMTs. Between May 2017 and February 2020, researchers recruited 259 participants 55 and older who had not had an acute MS relapse for at least five years and no new MRI lesions for at least three years from 19 MS centers in the United States. 

Using any new relapse or MRI scan change in more than two years as the main outcome, researchers wanted to know how discontinuation compared to staying on DMT. Only 22 of the 259 (six of the 128 in the continue group and 16 of the 131 in the discontinue group) total individuals had a new event (relapse or MRI scan change). By this measure, it could be worse to stop DMT, noting that 15 of the 22 of the new events were one to two new MRI lesions unaccompanied by any relapse or change in disability, and only four participants had an acute relapse. There was no increase in disability, symptom scores, cognitive tests, or adverse events in those discontinuing DMT. 

The researchers said the study addresses important concerns about the risks and benefits of DMTs as people age. The primary objective of the study was to identify whether discontinuation is safe to consider for older patients with MS and no recent relapse or new MRI activity. The goal was to provide an estimate of disease recurrence in this context.

The study’s authors concluded that while they were unable to show that discontinuation is better by their primary outcome, many patients 55 and older who have not had a relapse for five or more years might feel that the low risk of new clinical activity makes a personal discontinuation trial a reasonable option for them.

The findings were published in the journal Lancet Neurology.