The most recent data continue to support Mayzent‘s (siponimod) benefits and provide more insights on how this therapy can make a difference for those with relapsing forms of multiple sclerosis (MS) — in particular, data showing the therapy lowers the risk of becoming wheelchair-dependent.
New results from the pivotal Phase 3 EXPAND trial were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held Sept. 11–13 in Stockholm.
Approved by the U.S. Food and Drug Administration (FDA) in March this year, Novartis‘ Mayzent is a new sphingosine-1-phosphate (S1P) receptor modulator, indicated for the treatment of people with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).
Data from the EXPAND study (NCT01665144) was one of the key pieces of evidence for Mayzent’s approval. Involving 1,651 patients with SPMS (both active and non-active), the study showed that taking 2 mg tablets of Mayzent once per day reduced the risk of disability progression at three months by 33% in those with active, relapsing disease, and by 13% in those with non-active SPMS.
The therapy also decreased the annualized relapse rate by 55%, reduced the progression of brain lesions, and lessened whole-brain volume loss (brain atrophy), measured in the overall population (active and non-active SPMS); a further analysis demonstrated an additional benefit for improving cognitive processing speed.
“Patients with active SPMS benefit from Mayzent to a greater extent; however, this benefit is not restricted to active SPMS patients,” Douglas Arnold, MD, from McGill University in Canada, said at a Novartis media briefing held during ECTRIMS.
He believes that this increased benefit in these patients is a general phenomenon possibly related to the fact that they have more lesion formation and more inflammation, which worsens the degenerative process. So this could explain why they respond better and have a slower disease progression with anti-inflammatory therapies like Mayzent.
On that note, a post-hoc analysis presented by Arnold at ECTRIMS showed that Mayzent significantly slows the loss of both cortical grey matter and thalamic volume — two measures of brain atrophy — at two years, compared with placebo, in SPMS patients.
Overall, the data suggest that Mayzent offers a benefit in terms of physical and cognitive ability. But from a patient perspective, what does this mean? Are SPMS patients receiving Mayzent more “functional?”
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