Drs Scott Newsome and Ellen Mowry share their process for choosing disease-modifying therapies for newly diagnosed patients with multiple sclerosis.
Professor, Department of Neurology, Division of Neuroimmunology and Neurological Infections, Johns Hopkins School of Medicine; Director of Johns Hopkins Neurosciences Consultation and Infusion Center, Stiff Person Syndrome Center and Johns Hopkins Neuroimmunology and Neurological Infectious Disease Fellowship Program, Co-Director on Multiple Sclerosis Experimental Therapeutics Program, Academic hospital setting, Baltimore, MarylandServe as a director, officer, partner, employee, employee, advisor, consultant, or trustee for: Biogen, Genentech Inc; Bristol Myers Squibb; Novartis; TG Therapeutics Received research grant for institution from: Biogen; Lundbeck; Roche; Genentech Inc; Sanofi; National MS Society; The Stiff Person Syndrome Research Foundation; Department of Defense; Patient-Centered Outcomes Research Institute Professor, Department of Neurology & Epidemiology, Chief Medical Officer on inHealth, Co-Director of Johns Hopkins Multiple Sclerosis Precision Medicine Center of Excellence, and Associate Director of Johns Hopkins Neuroimmunology and Neurological Infectious Disease FellowshipJohns Hopkins University, Baltimore, MarylandScott Newsome, DO, MSCS:Thank you, Dr Newsome.
I am a neurologist and we have the pleasure of working together on many MS-related clinical trials, including trials that are looking at the best treatment strategies in individuals who are newly diagnosed with MS. It's definitely been an evolving landscape over time. I’m grateful to have the opportunity to work with you and the folks we serve to try to answer some of the big, unknown questions. , in fact, with different routes of administration and different efficacy and safety profiles based on clinical trials. It's good and bad, right? I think when you're seeing someone in the clinic and you're trying to decide which direction to go in with all these therapies, it is a bit of a conundrum. Ellen, what is your approach in clinic? You're seeing someone who's newly diagnosed with whatever type of MS — mild or highly active disease. What are the first steps in terms of selecting treatment? I think one of the main things to know early on is that it's not usually a conversation these days that can occur in a very short period of time. The first thing I think about when I'm talking to someone to whom I've newly given an MS diagnosis is that this takes time to process — just the diagnosis, never mind thinking about and then The first thing I often teach our fellows is to say, give it some time and anticipate two to three visits in order to discuss an appropriate treatment strategy. I think you and I probably have a pretty similar approach in that regard. Many of the people we see have seen other physicians, and they might even be coming for a second opinion about treatment. It's really interesting to hear the different ways in which treatments have been presented in terms of options by other clinicians. Definitely there's heterogeneity among neurologists in terms of how we're talking to our patients about treatment options. Even among MS specialists, right? It's really fascinating, the pros and cons, in how you present information. What is a bit troublesome to me in this day and age is there's a swing of a pendulum toward treating everyone with Hence, why we decided to do a study looking at these treatment strategies, whether to go full steam ahead with the “big hammer” to the immune system, for instance, with an infusion therapy, vs choosing a modestly effective drug that has a safety profile that may be more favorable, longer term. We need to know this information for our patients, because I think you and I and some of our other colleagues feel that, in the long term, some of our patients are going to have long-term side effects from using select high-efficacy drugs. We need to, I think, do more for our patients. With respect to other factors that you consider into the equation about which treatment strategy you may go toward, like non-efficacy factors, I'd love to hear your thoughts. I think that the time of choosing the first disease-modifying therapy for patients’ is a classic example of the importance ofI like to explain that we're fortunate to be in a time where we have so many medications available and to really acknowledge that choosing such a medication is overwhelming. We often then start talking about the broad strategy of either starting with a higher-efficacy medicine or a more moderate-efficacy medication, and in all cases, of course working to make sure we're monitoring correctly. At that stage, I sometimes discuss “in broad strokes” what some of the pros and cons of the medications within each strategy might be, and I also try to understand a little bit more about the individual patient in terms of how they feel with respect to the slightly higher risks associated with using moderate-efficacy medicine, such as having a new lesion or relapse, vs the risks of infections or other potential adverse events that might be a little bit more overrepresented in the higher-efficacy therapies. I think about, for many of our patients who may be of childbearing potential, when they're thinking about having children. I think about comorbidities because some of the medications have side effects that might exacerbate some of those comorbidities. In my mind, I'm formulating and reducing the list of medication classes and considering all of these things. For instance, many people haven't had safety screening labs when we first meet them. Rather than discuss every single option as if it's equally suitable, I try to narrow down that list. Maybe by the end of the first visit, if it seems appropriate, I’ll say, these are the kinds of things that I'm thinking about, but we'll need to do some safety labs before starting therapy. I'd like you to go home and think about your options a little bit more. Write down every question you have, and we'll bring you back in in quick succession to discuss it a little bit further. I like that approach. I do a very similar approach. I really like the approach of trying to know your patient.and OPTI-TREAT-MS, which is going to be an extension of that. What are you excited about? We don't have any results yet. What most excites you about these studies?is a large, multicenter, pragmatic, randomized controlled trial that you and I are running, Dr Newsome, in which people who are newly diagnosed and haven't started an MS therapy yet are randomized by flip of a coin to one of two treatment strategies. People will either be starting with a higher-efficacy medication or with a moderate-efficacy medication, and in both cases, they are going to be followed, just like they would be in the real world, with clinic visits every 6 months, routine MRI scans, etc. In instances where the medication isn't working, for example if there's breakthrough disease shown on MRI or a relapse occurs, people are allowed to switch medications. We're pretty hopeful that this trial will provide some evidence for clinicians to use in guiding their patients, who are in the same situation, over time. This trial came about because we see many people who are newly diagnosed with MS and they ask, well, what medicine would you choose? As a clinician, you're trying to run through the options in your head and the literature that's available. that people have often claimed show that one treatment strategy is preferential to the other, those data sets aren't actually evaluating treatment strategy and are subject to so much bias that it's really uncomfortable as a clinician to pretend that the data are strong enough to provide an exact answer to each person. I'm excited because, whatever the answers are from the TREAT-MS trial, I think that it will give us confidence as clinicians that the evidence base is there for whatever we're discussing with the next person we see who is newly diagnosed with MS. I think the trial is exciting, too, because of the way it was designed. Stratifying the randomization, depending on whether people looked like they had pretty active MS at the beginning or less so, might tell us if the results are the same for both groups, in which case there is more of a one-size-fits-all type of answer, or if there is some sort of strategy that's most appropriate for people with different risk profiles.Even if we find that there’s a subgroup of people that have to start on aggressive immune treatments, whether it's an infusion therapy or an oral therapy that has stronger efficacy, that's going to be huge, because I think we'll be able to look at patients and say, we know your MS is going to, without a doubt “get you into big trouble” in the future from a progression and disability perspective. We have the data here to support going for an early, aggressive treatment approach vs another group that maybe doesn't have that same risk profile. I'll say the other thing I'm really excited about is the biomarker component of this trial. We're doing a biobanking sub-study at different time periods throughout the trial. Maybe we'll find that the evidence that helps determine the risk profile, and whether a treatment is working for an individual over time, is in the blood. We have so many other things that are built into the protocol, but like you said, whatever we learn is going to be evidence-based. This is a prospective, randomized trial, not a retrospective study looking back. We're really excited about that. The other thing that I'm really excited about is the extension to the TREAT-MS trial, OPTI-TREAT-MS. We need to continue to collect data so we have trial data for longer periods. If we're going to look at progression specifically, we know progression doesn't happen overnight. It's really a long-term outcome that occurs. With OPTI-TREAT-MS, our goal is to continue collecting data, especially the primary outcome data of disability progression measured by the Expanded Disability Status Scale Plus. Just to say a couple of final comments about TREAT-MS: We started in 2018, and here we are in 2025. We're finally coming to an end where we'll have our primary analysis data. The end of the study is August 2026 for the core trial. Shortly thereafter, we're going to have an answer, at least from the primary endpoint perspective. I'm really excited to be able to share that. Fast Five Quiz: How Do You Manage Multiple Sclerosis Symptoms? Skill Checkup: A 32-Year-Old Woman With Clinically Isolated Syndrome, Coldness in Her Legs, and Facial Twitching Skill Checkup: A 60-Year-Old Man With Depression and Anxiety Presents With Leg Weakness, Fatigue, and Cognitive IssuesAll material on this website is protected by copyright, Copyright © 1994-2025 by WebMD LLC. This website also contains material copyrighted by 3rd parties.
Multiple Sclerosis Center Of Excellence Multiple Sclerosis Multiple Sclerosis (MS) Disease-Modifying Therapy Disease-Modifying Therapy (DMT) Patient Safety Disability Healthcare And Medical Technology Health And Medical Tech Health And Med Tech Health And Medical Technology Healthcare Technology Medical Technology Adverse Effects Side Effects Clinical Research
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Gretchen Whitmer’s unexpected Oval Office invite highlights balancing act with TrumpDemocratic Michigan Gov. Gretchen Whitmer visited the White House on Wednesday with a bipartisan delegation to discuss a laundry list of issues affecting her state, including a recent ice storm, funding for an Air National Guard Base and tariffs.
Read more »
From public school reject to cafeteria Catholic: Balancing tradition, faith and kids in Our Best LifeRoman Catholics are holding steady at 20% of the U.S. population. I'm definitely a cafeteria Catholic.
Read more »
Jenna Ortega: Balancing Blockbusters and Original StoriesJenna Ortega, known for her roles in 'Wednesday' and the 'Scream' franchise, talks about balancing her success with her desire to choose projects that challenge her creatively.
Read more »
Viral video shows man biking in NYC while balancing refrigerator on headToday's Video Headlines: April 19, 2025
Read more »
Balancing Hollywood and home, Dave Maldonado shines in 2025With a dynamic career spanning over 15 years, actor Dave Maldonado continues to carve out an impressive path in Hollywood while staying true to his Gulf Coast roots.
Read more »
How Gavin Newsom is balancing the fight against Trump with Los Angeles fire reliefCalifornia's governor shifts from détente to resistance as he sues Trump over tariffs while still seeking $40B in federal aid.
Read more »