Siponimod and cognition in secondary progressive multiple sclerosis: EXPAND secondary analyses
Journal: 2020/December - Neurology
Abstract:
Objective: To investigate the effects of siponimod on cognitive processing speed (CPS) in secondary progressive (SP) multiple sclerosis (MS) patients, by means of a pre-defined exploratory, and post-hoc analysis of the EXPAND study, a randomized controlled trial (RCT) comparing siponimod and placebo.
Methods: EXPAND was a double-blind, placebo-controlled, phase 3 trial involving 1651 SPMS patients randomized (2:1) to either siponimod 2 mg/day or placebo. Cognitive function was assessed using the Symbol Digit Modalities Test (SDMT), Paced Auditory Serial Addition Test (PASAT) and Brief Visuospatial Memory Test-Revised (BVMT-R), administered at baseline, 6-month intervals, and end of treatment.
Results: Between-group differences in mean change from baseline in SDMT scores were significantly better in siponimod- vs placebo-treated patients at Month 12 (difference 1.08 [95% CI 0.23, 1.94]; p=0.0132), Month 18 (1.23 [0.25, 2.21); p=0.0135), and Month 24 (2.30 [1.11, 3.50]; p=0.0002). Siponimod-treated patients were at significantly lower risk for having a 4-point sustained decrease in SDMT score (hazard ratio [HR] 0.79 [0.65, 0.96]; p=0.0157) while their chance for having a 4-point sustained increase in SDMT score was higher [HR 1.28 [1.05, 1.55]; p=0.0131). PASAT and BVMT-R scores did not differ significantly between the two treatment groups (all p>0.28).
Conclusion: Siponimod had a significant benefit on SDMT in SPMS patients. Siponimod-treated patients were at significantly lower risk for having a ≥4 point decrease in SDMT score and had a significantly higher chance for having a ≥4 point increase in SDMT score, a magnitude of change accepted as clinically meaningful.
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