Siponimod Reduces Risk of Disability Progression Regardless of Prior Relapses in MS

Data from the phase 3 EXPAND clinical trial (NCT01665144) of siponimod (Mayzent; Novartis) demonstrated the treatment’s ability to reduce the risk of confirmed disability progression (CDP) in patients with secondary progressive multiple sclerosis (SPMS) with or without relapses.The risk reductions in non-relapsing patients in the 1 and 2 years before the study were 18% (hazard ratio [HR], 0.82; 95% CI, 0.66–1.02) and 13% (HR, 0.87; 95% CI, 0.68–1.11), respectively. For 3-and 6-month CDP, the risk reductions were 25% (HR, 0.75; 95% CI, 0.59–0.96) and 18% (HR, 0.82; 95% CI, 0.62–1.08), respectively.

Click HERE to Subscribe for the MS Beacon NewsletterData presented at the 2020 Consortium of Multiple Sclerosis Centers (CMSC) Virtual Annual Meeting, May 26-29, 2020 revealed risk reductions of 33% and 33% for 3-month CDP in years 1 and 2, and 30% and 37% for 6-month CDP in years 1 and 2, respectively, in relapsing patients.Bruce Cree, MD, PhD, MAS, lead author, and neurologist, UCSF Multiple Sclerosis Center, and colleagues found that siponimod reduced 3-month CDP by 14% to 20% and 6-month CDP by 29% to 33% in non-relapsing patients across the Month 12, Month 18, and Month 24 timepoints.Cox model censoring at relapse confirmed these beneficial effects, reaching nominal statistical significance for 6-month CDP (HR, 0.77; 95% CI, 0.62–0.96).

The goal of the EXPAND trial was to assess the impact of siponimod on CDP in patients with and without relapses to uncouple treatment effects of CDP from those on relapses. EXPAND contained patients aged 18 to 60 years with SPMS and EDSS scores ranging from 3.0 to 6.5, and administered once-daily oral siponimod 2 mg or placebo for up to 3 years.

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