The year 2025 was not an easy year. It was characterized by intense political, economic and social developments. The war in Ukraine, the Gaza crisis, geopolitical tensions, but also domestic political disputes kept us on our toes. – The world is changing.
As for MS, in contrast to the general situation, it was not a year of major upheavals. At present, there is rather a consolidation of the current concepts. It is now widely agreed that MS is not a sequence of different disease phases, but a continuum in which different pathological processes are present from the very beginning. The traditional division of MS into relapsing, secondary chronic-progressive and primary chronic-progressive is therefore becoming increasingly less important.
2026: Continuum, BTKi, CAR-T cells and sNFL
This development is also reflected in the current revision of the McDonald criteria from 2024, which was published in September 2025. Here, no distinction is made anymore between diagnosis criteria of relapsing and progressive MS. Furthermore, the current revision of the McDonald criteria aims to make the criteria even more sensitive, so as to enable an even earlier and more efficient therapy of the disease with an even earlier diagnosis.
There were no news about new therapeutics in 2025 – the data on Tolebrutinib were already communicated last year. And give hope that the substance class of BTKi has added value in the treatment of progressive MS. However, there is still no approval, so one will certainly have to wait until the first quarter of 2026 before application of Tolebrutinib will be possible in practice. Furthermore, CAR-T cells as a new and very exciting therapy option have attracted interest, but so far only a few individual case reports are available. – Too few to make statements about this therapy option outside of clinical trials.
Another development in 2025 is that sNFL (serum neurofilament light chains) are being used more and more in routine care. This is also necessary to gather nationwide experience with this biomarker. However, it is already apparent that there is still a need for discussion regarding the “right” assay, i.e., the test system. And the question of whether to work with Z-scores (standard values) or absolute values needs to be answered. It is foreseeable that it will therefore take a little longer until this marker has fully arrived in the routine care of MS patients.
In contrast to the turbulent political times, in the field of MS, 2025 was rather a year to catch one’s breath and sort out concepts – which is not a bad thing after all. Ultimately, one would wish for such a year politically and socially as well. Just take a deep breath and get things back on track.
New Approval(s) 2026?
In the MS therapy landscape, 2026 can happily be more exciting again – and it probably will be. As already mentioned, we will most likely have Tolebrutinib, a new drug for the treatment of progressive MS, available. In addition, the press release from Roche in November 2025 (MS Docblog had reported) gives hope that we will soon have new insights into another BTKi. These innovations will very likely also have an impact on the current therapy algorithm – it will definitely be exciting.
In this sense, I wish all my readers a merry and contemplative Christmas, restful holidays and a good start into a happy New Year.
This post was translated from German to English with the help of AI.
