A clinical study now enrolling people with progressive or relapsing multiple sclerosis (MS) will examine the feasibility of older patients stopping use of disease-modifying therapies if they have had no relapses for a number of years.
John Corboy, with the University of Colorado School of Medicine, presented the study at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, along with an explanation of why he believes older MS patients could quit treatment.
The presentation, “Disease-modifying therapy in the aging multiple sclerosis patient,” reviewed data showing that relapses are more common in younger MS patients, and less frequent as patients age.
This data is supported by autopsies of MS patients’ brains, showing plenty of inflammatory lesions in young patients, while people over age 50 most often lack apparent signs of inflammation.
Degeneration of brain and spinal cord tissue starts early in the disease and continues throughout life. But current disease-modifying drugs have little impact on the accumulation of disability that likely is a result of this continual damage to tissue.
Analyses of age groups in clinical trials of disease-modifying drugs show better effects in the young, particularly in those younger than 40.
Corboy also underscored that the vast majority of clinical trials have not studied disease-modifying therapies in patients older than 55.
Studies examining the effects of halting therapy in older MS patients are few. Still, available data suggests it may be reasonable for older patients with an extended period of no disease activity to stop. Most patients at present continue taking disease-modifying drugs throughout their life.
The study, called DISCOMS (NCT03073603), will recruit up to 300 patients at 15 clinics across the U.S. to study if treatment discontinuation for these patients is a good option. Patients need to be at least 55 years old, and be free of relapses and magnetic resonance imaging (MRI) changes for at least five years while on any of the 14 approved disease-modifying therapies. (Enrollment information is available through this link.)
The team will randomly assign patients to a quitting or continuation group. Physicians examining patients will not know which have stopped disease-modifying treatment in order to minimize the risk of bias.
The trial will run until 2021, but Corboy expects the first data to be available about a year earlier.
While this study will help patients and neurologists in making treatment decisions, it also highlights the need for treatments that “diminish neurodegeneration and enhance central nervous system recovery and/or regeneration,” Corboy concluded.