ECTRIMS 2025 | Assessing treatment efficacy in MS and NMOSD: moving beyond relapse rates
Celia Oreja-Guevara, MD, PhD, University Hospital San Carlos, Madrid, Spain, discusses the challenges of assessing treatment efficacy in multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) due to the low relapse rates achieved with current high-efficacy treatments. Prof. Oreja-Guevara highlights the need to explore alternative outcomes beyond relapses, such as digital technologies, biomarkers like neurofilaments, and optical coherence tomography. This interview took place at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.
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Transcript
So nowadays, we have our patients with multiple sclerosis because of the new treatments, the high and very high efficacious treatments, our patients, they have very, very few relapses. So that is really a problem because before, the primary objective of the clinical studies, they were relapses. And now the patients, they don’t have relapses. So that in the last trials that we have seen with the BTKs, the last trial with relapsing-remitting MS with the BTK, we have seen that the relapse number was so low that there was no difference between the new treatment and the old treatment...
So nowadays, we have our patients with multiple sclerosis because of the new treatments, the high and very high efficacious treatments, our patients, they have very, very few relapses. So that is really a problem because before, the primary objective of the clinical studies, they were relapses. And now the patients, they don’t have relapses. So that in the last trials that we have seen with the BTKs, the last trial with relapsing-remitting MS with the BTK, we have seen that the relapse number was so low that there was no difference between the new treatment and the old treatment. So that we need to think, we need to look for other outcomes, for other objectives that they cannot be relapses and they cannot be only lesions. So that in the talks, it was very clear, the need to look for other outcomes, outcomes that they could be easier to achieve. And perhaps we can use some digital technologies or some smartwatch or smartphones that the patients can use every day and we can see differences. Or perhaps we can use things like body fluids to measure the neurofilaments in blood. That is very easy and we can do every three months. Or we can try to use, for example, other technologies like the OCT, the optical coherence tomography. So that the message was very clear. In MS patients, we need to look for other different outcomes. We cannot use more relapses for relapsing-remitting MS. So that we need to look at technologies or some digital tools or other biomarkers like neurofilaments and GFAP. And regarding the NMO, it was very similar because the problem is that now the patients with NMO, they are treated with the new treatments or with the rituximab. They have the same, very few relapses. And because they have very few relapses, it’s very difficult to see relapses in a short study of two years, so that they were the same plan for NMO patients with the difference that the patients with NMO don’t have progression, so that we cannot use things like the EDSS or things like a worsening of the walk with the 25-foot walking test, or we cannot use things like the PILs or the cells in MRI. So that is for both NMO and MS. The most important thing now is to look for new outcomes to really find the differences between the treatments. And for the NMO, it’s a little more difficult because the patients with NMO, they don’t have progression.
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