Cleveland Clinic wins funds to compare RRMS treatment strategies
PCORI funds will support extension of clinical trial
The Patient-Centered Outcomes Research Institute (PCORI) has awarded the Cleveland Clinic $6.7 million to identify optimal treatment strategies for people with relapsing-remitting multiple sclerosis (RRMS).
The funds will support the extension study of the multicenter DELIVER-MS (NCT03535298) clinical trial. The study is comparing two MS treatment approaches head to head: starting patients on high-efficacy therapies that can reduce MS activity but carry greater safety risks, or beginning with safer, but potentially less effective, treatments and then escalating to high-efficacy therapies as needed.
The project, dubbed “Determining the Long-term Effectiveness of Early Intensive Versus Escalation Approaches for Prevention of Disability in Relapsing-remitting Multiple Sclerosis,” will be led by Daniel Ontaneda, MD, PhD, a neurologist at the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic.
“Having more than two dozen approved MS treatment options is a huge advantage for doctors and patients, but there are currently no definitive data from randomized controlled trials to guide the choice between early intensive and escalation approaches,” Ontaneda said in a Cleveland Clinic news story. “The funding provided by PCORI to support DELIVER-MS, and the forthcoming extension study, will address this knowledge gap and help inform clinical decision-making moving forward.”
Disease-modifying therapies (DMTs) approved for people with relapsing forms of MS are broadly categorized into two groups: high-efficacy and low-efficacy treatments. Newer, high-efficacy DMTs potently reduce MS activity and slow disease progression but are associated with more severe side effects and are more costly. Older, low-efficacy DMTs are less effective at slowing the disease but are generally safer.
RRMS treatment often starts with low-efficacy treatment
Clinicians often start treatment with low-efficacy agents, and if patients show signs of disease activity, they will escalate to high-efficacy DMTs. However, growing evidence suggests that starting patients on high-efficacy DMTs results in slower disability progression than those on escalation treatment.
The Cleveland Clinic launched the DELIVER-MS study in 2019 to answer the question: Does early treatment with highly effective DMT improve the outcomes for people with RRMS? For three years, the study followed 800 RRMS patients who started treatment with one of the two regimens and assessed the impact of each approach on brain volume loss using MRI scans.
The new project, co-led by Emma Tallantyre, PhD, a clinical reader at the University of Cardiff, will continue to follow DELIVER-MS enrollees to assess disability outcomes over a nine-year period. The long-term follow-up aims to generate a more comprehensive understanding of treatment approaches for MS.
Johns Hopkins University in Baltimore is conducting a similar study, TREAT-MS (NCT03500328), involving 900 adults with RRMS. Researchers are comparing the impact of an early, aggressive treatment approach with high-efficacy versus low-efficacy DMTs on the intermediate term risk of disability. They will also assess disability risk among those who begin on a low-efficacy DMT but switch after signs of disease activity to either a second low-efficacy or a high-efficacy therapy.
PCORI also awarded the Cleveland Clinic nearly $1 million to implement a program for managing high blood pressure, also known as hypertension, across internal medicine and family medicine practice sites in northeast Ohio.
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