How Well Does Disease-Modifying Therapy Work for Older Adults with MS?

Discontinuation of disease-modifying therapy leads to only minimally increased risk of disease progression in older adults with multiple sclerosis (MS), according to a recent study published in Lancet Neurology¹.

There is no known cure for MS, but numerous disease-modifying therapies (DMTs) are available that are proven to significantly reduce the risks of recurrent attacks and MRI changes associated with progressive disease. Onset and progression of MS occurs primarily in young and middle-aged adults. Accordingly, most DMTs have received approval based on studies conducted solely on patients aged 55 and younger.

While the potential risk and severity of side effects of DMTs typically increase with age, the benefits of DMTs in older MS patients is uncertain. It is an open question whether it is reasonable for older adults to discontinue DMTs. Will discontinuation lead to more frequent relapses or might it spare people side effects and not lead to a worsening of the disease?

In attempt to answer that and other questions, investigators from across the United States enrolled more than 250 MS patients aged 55 and older receiving DMTs in the DISCOMS clinical trial. Importantly, individuals having a relapse or those experiencing disease progression were excluded from the trial. Half of the eligible patients continued to take their medication, while the other half discontinued their treatment regimen. The research team followed up with each patient for two years, assessing new relapses into MS and MRI changes. The investigators also monitored adverse events, which included any sign, symptom, or condition considered undesirable by the patient.

Lead author John Corby, M.D., a University of Colorado MS expert, and his colleagues saw modest MS disease activity across both groups, as was expected for the patient population. Importantly, they found no significant difference between the groups with regards to the number of relapses or MRI changes associated with disease progression. About 5% of the patients in the continuation group experienced a relapse or MRI changes, while 12% of the patients who discontinued therapy experienced a relapse or MRI changes. This finding suggests that once disease progression has slowed or stopped in older MS patients, halting DMTs leads to small differences in overall outcomes.

Both groups experienced similar rates of adverse events. In the continued therapy group, 85% of individuals experienced adverse events, while 79% of those in the discontinuation group had adverse events. The discontinuation group experienced more overall adverse events (422 vs. 347), but the difference was not statistically significant.

Corboy and his colleagues noted some limitations on their findings, however. Due to the trial criteria excluding patients with recent progression or relapse of MS, the trial results cannot be extrapolated to those with a recent history of progression or relapse. Also, some newer treatment options for MS, such as fingolimod and natalizumab, were not used by patients in this study. The benefits of newer agents might surpass that of the DMTs considered in this study, thus may warrant continuation beyond age 55.

They concluded, “Discontinuation of disease-modifying therapy might be a reasonable option in patients older than 55 years who have stable multiple sclerosis but might be associated with a small increased risk of new MRI activity.”

Patients with MS should not stop taking any of their medications without first discussing the possible risks and benefits with their healthcare provider.

This article originally appeared in Managed Healthcare Executive.

Reference

Corboy JR, MD. Fox RJ, MD. Kister I, MD, et al. Risk of new disease activity in patients with multiple sclerosis who continue or discontinue disease-modifying therapies (DISCOMS): a multicentre, randomised, single-blind, phase 4, non-inferiority trial. The Lancent Neurology. Published July 2023. DOI: https://doi.org/10.1016/S1474-4422(23)00154-0