At the recent Consortium of Multiple Sclerosis Centers (CMSC) meeting, Ellen Mowry, MD, of John Hopkins University in Baltimore, presented the Presidential Lecture via livestream. Mowry described two ongoing clinical trials, TREAT-MS and DELIVER-MS, that are addressing whether an escalation or early higher-efficacy therapeutic strategy will impact the longer-term prognosis of a person with newly diagnosed, relapsing multiple sclerosis (MS).
In this exclusive MedPage Today video, Mowry describes the design and implications of the studies presented at her lecture.
Following is a transcript of her remarks:
Hi, I’m Dr. Ellen Mowry. I’m a professor of neurology and epidemiology at the Johns Hopkins University. I recently had the opportunity to give the presidential lecture at the CMSC annual meeting. And I was really talking about escalation versus early aggressive therapy, which is the subject of our ongoing TREAT-MS trial, which means traditional versus early aggressive therapy for MS. We’re specifically talking about the rationale for the trial. Why, given the recent evidence from observational studies that suggest that perhaps using stronger medications in all people with MS might be warranted, do we still think that that evidence base is not strong enough to support that uniform recommendation and therefore why we’re doing this study.
TREAT-MS is sponsored by PCORI, the Patient-Centered Outcomes Research Institute, and it’s enrolling 900 individuals with relapsing-remitting multiple sclerosis. It’s a pragmatic trial, so it’s really meant to mimic a lot of the things that occur in the real world, rather than being a super regimented trial such as those that are sponsored by pharmaceutical companies and we’re really testing treatment strategies. So if I see a person in my office is newly diagnosed with MS and they say, ‘Doc, which medication should I choose? And should I use these stronger medications first, or should I use the more modest efficacy medications, which may have a better safety profile but may increase my risk of a relapse? What should I do?’
So in this study, we’re randomizing people 1:1 to receive the stronger medication choice right upfront, or to using the escalation approach beginning with a more moderate MS medication. And then we monitor people over time. And if, after the medication should have kicked in, there’s breakthrough or ongoing MS activity, we then of course kick it back to the clinician and the patient and say, ‘You might want to consider switching medication.’ And the clinician and the patient can make that shared decision together.
Some interesting parts about TREAT-MS are that we are stratifying the randomization based on disability projections at the beginning, so that hopefully we’ll be able to see if there is a difference in these strategies. Is that difference in improvements or lessening of disability the same if you started with some higher risk indicators for MS, or is it pretty equal across groups, or perhaps there is no difference at all.
The TREAT-MS trial is also following a number of traditional outcomes in addition to disability, which is the primary outcome. Things like the MS functional composite, patient-reported outcomes like quality of life metrics and MRIs. But we’re also trying to capture some unique outcomes, such as how many symptoms of MS does a person experience or accrue throughout time, how many medications or tingling numbness or depression, things that might not get captured at disabilities cohort, is there a difference how many of those medications a person has to be on over time based on what medication they initially received.
So we think that it’s a pretty unique study. We’ve harmonized a lot with the DELIVER-MS study, which is being run out of Cleveland and the UK. So ultimately we hope that we can explore some of the outcomes for their consistency across the studies. And we’re really looking forward to finalizing our recruitment and to getting these answers to people with multiple sclerosis.
Source: MedicalNewsToday.com
