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“We saw that cognitive deficits at baseline were predictive of further deterioration during follow-up. Cognitive assessment appears to be an important clinical sign of clinical disease severity, not only cross-sectionally, but also if one look at the following years.”
Despite the expansion of disease-modifying therapies for patients with multiple sclerosis (MS), there are still complications related to treatment selection, as different clinical and demographic profiles may respond differently depending on their underlying pathophysiology. underlying. To estimate the profile of responders to treatment, the investigators conducted a post hoc analysis of the phase 3 EXPAND study (NCT01665144), which evaluated the effect of siponimod (Mayzent; Novartis) in patients with secondary progressive MS.
Presented at the 2022 Annual Meeting of the American Academy of Neurology (AAN), April 2-7, in Seattle, Washington, the researchers took an innovative statistical approach combining the concept of defining responders with therapy based on their basic profile. The analysis generated a response score derived from baseline characteristics describing the effect of patient treatment on 4 clinical criteria: Extended Disability Status Scale, 25-foot timed walk, 9-hole ankle test, and test modalities of symbols and numbers.
Four different responder profiles were obtained and validated, all showing a significant interaction with the treatment, thus defining the responders to each of the 4 results. Overall, 78% (1290 of 1645) of patients were marked responders to siponimod treatment in at least 1 of 4 clinical outcomes. Ludwig Kappos, MD, FEAN, FAAN, study investigator, believes that cognitive assessment is important as an aspect of prognosis, but also as a measure of treatment effect. Kappos, professor of neurology at the University of Basel, spoke with NeurologyLive® to discuss the analysis, some of the takeaways, and whether this is something that can and should be replicated in the future.