ACTRIMS 2026 | The future of using brain atrophy by MRI as a primary outcome measure in MS clinical trials
Gary Cutter, MS, PhD, UAB School of Public Health, Birmingham, AL, discusses the future of using brain atrophy measured by MRI as a primary outcome measure in multiple sclerosis (MS) clinical trials. Prof. Cutter suggests that more research is needed to investigate the linkage between progression and brain volume loss at the individual level. He also highlights the need for more targeted measurements on MRIs. This interview is part of our coverage of the 11th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held in San Diego, CA.
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Transcript
So where is it going? I think we have to do more to investigate whether there is a better linkage between progression. All of these data that are shown in these clinical trials with brain atrophy are shown in the aggregate. It’s the mean of this population versus the mean of that. And what we need to potentially do and start with, and I brought this up at the conference, let’s look at the people who actually had disability progression...
So where is it going? I think we have to do more to investigate whether there is a better linkage between progression. All of these data that are shown in these clinical trials with brain atrophy are shown in the aggregate. It’s the mean of this population versus the mean of that. And what we need to potentially do and start with, and I brought this up at the conference, let’s look at the people who actually had disability progression. Did those individuals have significantly more brain volume loss than everybody else? Can we show that at the individual level, looking at, you know, individuals who lost some, you know, had more disability, did they lose more brain volume, giving a little more to the face validity that it’s measuring something at the individual level. And then the second is, I think we need to do more with maybe more targeted measurement on the MRIs. Maybe we should be looking at actual levels of certain types of tissues that are changing or disappearing or remyelinating or whatever. And people are working on those, but I don’t think we’re there yet. I don’t think we’re going to abandon the MRI, but we need to make sure that, it is an expensive tool. So it should indeed be meaningful in relapsing-remitting. And it’s used quite frequently to see if there’s remaining activity or new activity occurring in someone’s brain. And they may use that to change therapy. And I’m not competent or trained enough to say whether that’s a good or bad thing. But as for brain volume, I think it needs to be shelved as a primary outcome measure, at least until we can show that it has clinical meaning at the individual level.
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Disclosures
Data and Safety Monitoring Boards: Applied Therapeutics, AI therapeutics, Amgen-NMO peds, AMO Pharma, Argenx, Astra-Zeneca, Bristol Meyers Squibb, CSL Behring, , DiamedicaTherapeutics, Horizon Pharmaceuticals, Immunic, Inhrbx-sanfofi, Karuna Therapeutics, Kezar Life Sciences, Medtronic, Merck, Meiji Seika Pharma, Mitsubishi Tanabe Pharma Holdings, Prothena Biosciences, Novartis, Pipeline Therapeutics (Contineum), Regeneron, Sanofi-Aventis, Teva Pharmaceuticals, United BioSource LLC, University of Texas Southwestern, Zenas Biopharmaceuticals.
Consulting or Advisory Boards: Alexion, Antisense Therapeutics/Percheron, Avotres, Biogen, Clene Nanomedicine, Clinical Trial Solutions LLC, Endra Life Sciences, Genzyme, Genentech, Immunic, Klein-Buendel Incorporated, Kyverna Therapeutics, Inc. , Linical, Merck/Serono, Noema, Neurogenesis, Perception Neurosciences, Protalix Biotherapeutics, Regeneron, Revelstone Consulting, Roche, Sapience Therapeutics, Tenmile.
Dr Cutter is employed by the University of Alabama at Birmingham and President of Pythagoras, Inc. a private consulting company located in Birmingham AL.
