Dr Daniel Ontaneda Outlines 2 Approaches to Treating MS and the Trial to Identify the Best One

There are 2 approaches for treating multiple sclerosis (MS) and the DELIVER-MS study is the first to see which approach works better, said Daniel Ontaneda, MD, a neurologist at the Cleveland Clinic.

Transcript

What is the focus of the DELIVER-MS study and what are you and your team trying to determine?

The DELIVER-MS study is a randomized clinical trial that I am leading along with a professor in the United Kingdom, Nikos Evangelou, MD, DPhil. And this is a randomized control trial that, instead of comparing medication A versus medication B, we’re comparing 2 different radically opposite treatment approaches or treatment philosophies. On the one hand, we have escalation therapy, which is what we use most commonly. Which is you use modestly effective medications that are relatively safe early on in the disease, and as you see disease activity occur, or as disease activity occurs in the setting of the use of those medications you escalate to something more powerful.

The alternative to that is something we call early highly effective, which is using the very most powerful medications from the beginning of the disease. We think that probably makes sense from how the disease behaves. Typically, inflammation is most intense at the very beginning, when a person is newly diagnosed. And over time, inflammation tends to go away, and the number of relapses a person has tends to decrease over time. So, by using escalation approach, you’re essentially undertreating the disease early on and you might be overtreating later on. So, it’s kind of inverse of what you would want. The advantage of highly effective treatment used early on is that you’re kind of treating with powerful medications probably when the patient needs it the most.

We all have our thoughts on which we think works better, but there really is no studies to inform if one approach is better than the other. So, the Patient-Centered Outcomes Research Institute funded this study across 24 sites: 12 are in the United States and 12 are in the United Kingdom. And essentially, what we’re doing is we’re randomizing patients to 1 of the 2 treatment arms. Once they’re randomized, then the patient can decide which medication within that group they want to be on, and that’s a decision that’s up to the patient and up to the clinician. In that sense it’s something we call a pragmatic clinical trial.

We’ve just started enrolling into that study. Our primary outcome is going to be brain volume loss. Our ideal study would have looked at outcomes 10 years after we randomized people, but because funding is typically shorter term, it’s only a 5-year window for funding. We basically selected an outcome measure that we thought would be highly predictive of subsequent disability, and that’s brain volume loss.

So, we’re excited that the study has already started, we’ve been enrolling very quickly, especially in Cleveland and some of our other sites. There’s a companion study to ours, which was funded at the same time, which is called TREAT-MS. We’ve homogenized the 2 studies. So, I think these 2 studies together over the next, you know, 5 to 6 years, will provide really compelling evidence to demonstrate if taking the approach of using highly effective medications early on really improves outcomes for patients. And I think that’s the first step in trying to decide what medication is best for patients. The problem we have now is that we have 14 medications, but we don’t know how to choose which one to start, so this is kind of the first step to try to help us answer that question.