Can elderly MS patients safely stop treatment? Study aims to find out.

A first-of-its-kind study is aiming to determine whether older adults with multiple sclerosis (MS) can safely stop taking disease-modifying therapies, also known as disease-modifying agents (DMAs).

The project is being led by scientists at the new P-HOPER Center, officially the Population Health Outcomes and Pharmacoepidemiology Education and Research Center, launched earlier this year at the University of Houston College of Pharmacy.

The work is supported by $1.6 million in funding from the Agency for Healthcare Research and Quality. That grant from the agency, one of 12 within the U.S. Department of Health and Human Services, is the first awarded to the new center.

“There is an urgent need to evaluate the benefits and safety of DMA discontinuation in older adults,” Rajender Aparasu, PhD, director of the P-HOPER Center and the study’s leader, said in a university press release. The release noted that “most patients with MS over age 65 have very limited disease activity and relapses.”

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Pharmacoepidemiology — the focus of this study — refers to how medications are used in the real world and how they affect patients’ health outcomes. The term deprescribing concerns the process of tapering, stopping, discontinuing, or withdrawing medications.

According to the researchers, neither has been effectively studied in elderly patients with MS.

“Although some studies with limited samples found preliminary evidence for DMA discontinuation, no large-scale pharmacoepidemiologic study evaluated both the safety and effectiveness of DMA deprescribing in older adults,” said Aparasu, also a professor at the University of Houston.

Disease-modifying agents are medications that have been proven to slow the progression of MS. There are about two dozen DMAs approved to treat relapsing types of MS in the U.S.

All of these medications work to reduce the activity of the immune system, which dampens the inflammatory autoimmune attack that drives MS symptoms.

While DMAs can be highly effective for slowing disease progression and preventing relapse activity, continuing to take these medications over the course of a lifetime can be burdensome for the patient.

In addition to costs and logistical issues with actually getting the medicines, DMAs, like any medication, carry risks of side effects. In particular, due to their immunosuppressive effects, most DMAs are known to increase the risk of infections.

Given that accumulating evidence suggests that inflammation, disease activity, and relapses are generally reduced in MS patients older than about age 65, some clinicians believe it may be reasonable to discontinue DMAs for these elderly patients.

The new project aims to test this idea.

We think we will find that there is no difference in relapse rates and frailty in older adults who are deprescribed and those who continue DMA, and that DMA deprescribing is associated with decreased infection rates and all-cause mortality in older adults with MS.

In this longitudinal study, scientists will be analyzing data from MS patients older than 65 who have a history of DMA use based on 10-year data from Medicare, the U.S. government program that provides health insurance to the elderly.

The scientists will compare outcomes for patients who continue on DMAs versus those who are deprescribed these medications. This will be the first national study to assess real-world outcomes for discontinuing DMAs in elderly adults with MS, according to the team.

“We think we will find that there is no difference in relapse rates and frailty in older adults who are deprescribed and those who continue DMA, and that DMA deprescribing is associated with decreased infection rates and all-cause mortality in older adults with MS,” Aparasu said.

Data are expected to help optimize prescribing practices, health outcomes, and quality of life for older MS patients.