AAN 2026 | Real-world outcomes of patients with multiple sclerosis treated with five years of cladribine

Let me start with a small background information. In the original CLARITY trial and its extension, there were only four-year follow-up in patients treated with cladribine. And we wanted to know what’s going on beyond this time point. And also we wanted to look at patients who are pre-treated who are older than in the trial so we wanted to look at real-world data. For this we used the Czech national MS patient registry which covers more than 80 or 85 percent of the Czech population so it’s quite a coherent cohort and we identified until the end of year 2025 around 2,000 patients who initiated cladribine and out of those 2,000 patients almost 500 had at least five years of follow-up. From those patients, more than 90% were pre-treated. They weren’t treatment-naive, so we need to think about it when trying to understand our outcomes. And out of these 500 patients, about half of them in the fifth year didn’t need switching therapy or additional retreatment or an additional cladribine course so half of them just remained okay after the first two courses. A quarter of those patients needed retreatment with another cladribine course and a quarter of them were switched to another treatment. When we look at outcomes after those five years only about 42 percent of patients were relapse-free but like most relapses occurred within the first and second year so that’s something we can expect and after that relapse rates were really low and about 72 percent of those patients were confirmed disease worsening free and about 89 perceny of patients were PIRA-free that’s quite a good number I think. When we look at specifically a retreatment subgroup at those at that quarter of patients who were treated after five years, or among those five years, we can see that retreatment can be a really beneficial strategy. Because in the year prior to retreatment, about 40 percent of patients are relapse-free. But in the year after cladribine retreatment, it’s 80 percent so it looks really nice. As a lot of people are thinking about cladribine as an exit disease-modifying treatment strategy in multiple sclerosis we looked at a sub-cohort of patients older than 50 years or 50 years old and older. And we saw that the numbers are even better about 65% I think where didn’t need to switch therapy or to have a retreatment so although numbers are quite low in this sub-cohort, we have about we have about 50 of those patients, it seems that cladribine can be a good exit strategy. So to conclude this poster, I would like to say that about half of the patients, despite being not treatment-naive, do not need to be switched or to be retreated but in the subgroup who got another treatment course who were retreated retreatment seems to be a good strategy to control the disease activity and also that in the older patients cladribine treatment can be a good exit strategy.

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