Long-Term Data Show Sustained Benefit of Siponimod for Secondary Progressive MS

Siponimod (Mayzent, Novartis) had a sustained effect on slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS), according to new long-term data from a phase 3 study.  

The FDA approved siponimod, a next-generation selective sphingosine-1 phosphate receptor modulator, in March 2019 for the treatment of SPMS, making it the first treatment to be approved for the condition in 15 years. Siponimod is indicated for the treatment of adults with various relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Newly-released 5-year data from the EXPAND open-label extension trial assessed the long-term efficacy and safety of siponimod in patients with SPMS who, on entering the extension trial, either continued on siponimod treatment or switched from a placebo to siponimod.

Related: What Pharmacists Should Know About Multiple Sclerosis 

The study, which is ongoing for up to a total of 7 years, is the largest randomized, controlled study in SPMS to date, and includes 1651 individuals with a diagnosis of SPMS, according to Novartis.

According to the data, patients in the siponimod treatment group were significantly less likely to experience both 3- and 6-month confirmed disability progression (CDP) (p=0.0064 and p=0.0048, respectively) compared with the placebo switch group.

Additionally, the results also demonstrated a 52% reduction in annualized relapse rate (ARR) observed in the siponimod group compared with the placebo switch group. According to the Symbol Digit Modalities Test, risk of confirmed worsening of cognitive impairment at 6 months was reduced by 23% for the siponimod group when compared with the placebo switch group. These benefits were sustained for up to 5 years.

A new, separate post-hoc analysis from the trial also showed that siponimod consistently reduced cortical grey matter and thalamic atrophy in patients with SPMS, including in those with less active and more advanced disease.

“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,” 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 in a statement. “It’s never too early to stay ahead of progression in multiple sclerosis, since the early identification of physical and cognitive changes–even subtle ones–can indicate MS disease progression and therefore allow for timely intervention.”

References:

1. Novartis announces new Mayzent (siponimod) data show sustained effect in delaying disability for up to five years in patients with secondary progressive multiple sclerosis. News Release. Novartis; April 21, 2020. Accessed April 22, 2020. https://www.novartis.com/news/media-releases/novartis-announces-new-mayzent-siponimod-data-show-sustained-effect-delaying-disability-five-years-patients-secondary-progressive-multiple-sclerosis-spms