New data from the 5-year EXPAND open-label extension trial evaluating siponimod in patients with secondary progressive multiple sclerosis (SPMS) showed that the treatment slowed physical disability progression and provided cognitive benefits .
The open-label extension portion of the trial evaluated the long-term efficacy and safety of siponimod in patients with SPMS who either continued on siponimod in the extension part of the study or switched from placebo to siponimod (placebo switch group). Results showed patients in the siponimod group were significantly less likely to experience both 3- and 6-month confirmed disability progression (P =.0064 and P =.0048, respectively) compared with the placebo switch group.
In addition, patients in the siponimod group demonstrated a 52% reduction in the annualized relapse rate compared with the placebo switch group (P <.0001). At 6-months, the risk of confirmed worsening of cognitive impairment was significantly reduced by 23% in the siponimod group compared with the placebo switch group, according to the Symbol Digit Modalities Test (P =.0014). The siponimod group demonstrated sustained benefits for up to 5 years indicating the advantages of early treatment initiation.
Additional post-hoc analysis from EXPAND showed that in patients with SPMS, siponimod consistently reduced cortical grey matter atrophy by 48-116% (P <.01 at both 12 and 24 months) and thalamic atrophy by 30– 68% (P <.05 at both 12 and 24 months; except in those with disease duration >15 years [P =.1029 at 12 months]). Moreover, magnetization transfer ratio (MTR) results showed that siponimod significantly reduced demyelination and substantiated previous preclinical findings on remyelination.
With regard to safety, the incidence of adverse events was consistent with that observed in the controlled treatment period. The open-label extension trial is ongoing for up to a total of 7 years.
Siponimod, a sphingosine-1-phosphate (S1P) receptor modulator, is marketed under the brand name Mayzent and is indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Commenting on the studies, Bruce Cree, MD, PhD, MAS, Clinical Research Director and George A. Zimmermann Endowed Professor in Multiple Sclerosis, University of California, San Francisco, School of Medicine, said: “These data highlight the critical importance of early treatment intervention with a disease-modifying treatment, such as Mayzent, to ensure the best possible long-term outcomes for patients with MS who are experiencing progression.”
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