Treatment with Mayzent (siponimod) led to significant improvement in cognitive processing speed in patients with secondary progressive multiple sclerosis (SPMS), according to updated results of a Phase 3 trial.
Novartis’ findings, presented at the European Academy of Neurology (EAN) congress that ran June 29–July 2 in Oslo, also showed that baseline blood neurofilament light chain (NfL) levels may be a biomarker for SPMS, as they can predict cognitive impairment and disability worsening in this patient population.
The research into Mayzent’s cognitive benefits was disclosed at EAN in a presentation titled “Siponimod Improves Cognitive Processing Speed in Patients with SPMS: Results from Phase 3 EXPAND Study.” It was conducted in participants of the Novartis-funded EXPAND trial (NCT01665144).
Cognitive processing speed was assessed using the Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT). Of note, a four-point change in the SDMT score is considered clinically meaningful. The Brief Visuospatial Memory Test-Revised (BVMTR) was used to evaluate visual/spatial memory.
A total of 1,645 patients — 1,099 on Mayzent, and 546 on a placebo — underwent the three assessments at six-month intervals.
As assessed with the SDMT, SPMS patients on Mayzent in comparison with placebo experienced a 28.6% reduction in the risk of three-point confirmed cognitive worsening and 21.3% lower risk of four-point confirmed worsening.
Results at 24 months showed better scores in up to 40.8% of patients on Mayzent (considering a four-point improvement), compared to up to 30.2% of those on placebo. Change from baseline (study’s start) levels also favored Mayzent.
Results of the PASAT and BVMTR were similar between the two groups.
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