SPMS Patients on Mayzent Show Stable Disease in Real-world Study

EDSS scores over 1 year stable in most of 108 people, but side effects noted

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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Almost two-thirds of a group of 108 secondary progressive multiple sclerosis (SPMS) patients being treated with Mayzent (siponimod) remained stable for at least one year, and about 1 in 5 of them showed improvements, a real-world study from Germany found.

Nearly one-third of the total 227 SPMS patients evaluated also stopped the treatment within 1.5 years, with most (62.6%) discontinuations due to side effects.

“Treatment with siponimod had an overall stabilizing effect,” the researchers wrote. “However, there is a need for more intensive treatment management and monitoring to identify disease progression and [adverse events].”

The study, “Real-world evidence on siponimod treatment in patients with secondary progressive multiple sclerosis,” was published in Neurological Research and Practice.

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Oral Mayzent given to 227 SPMS patients with a median EDSS score of 6

People with multiple sclerosis (MS) typically are first diagnosed with relapsing-remitting MS, a form of the disease characterized by relapses, or episodes of new or worsening disease symptoms, interspersed with periods of remission in which symptoms ease.

Many with this type of MS go on to develop SPMS, marked by a gradual worsening of symptoms with or without occasional relapses.

Novartis’ Mayzent is an oral medication, approved in the U.S. for adults with relapsing forms of MS. In Europe, it is used to treat adults with SPMS and active disease, defined by the presence of relapses or brain lesions with active inflammation.

These approvals were based on findings from the EXPAND Phase 3 trial (NCT01665144), which enrolled 1,651 SPMS patients and showed that up to three years of Mayzent treatment significantly reduced the risk of disability progression, lowered relapse rates, and reduced the number of new or enlarging brain lesions.

However, “given that patients in the EXPAND study differ from real-world populations regarding both individual and disease-specific characteristics, this may lead to limited generalizability of results in standard clinical practice,” the researchers wrote.

In an attempt to better understand the treatment’s safety and efficacy, a research team led by scientists at University Hospital Düsseldorf examined the medical records of 227 SPMS patients using Mayzent.

Mostly women (56%), these patients had a mean age of 53.4 and they had been diagnosed an average of 16 years prior to starting the treatment. Most had been on other disease-modifying therapies, commonly Gilenya (fingolimod); Mayzent was a first treatment for eight people. Their median Expanded Disability Status Scale, or EDSS, score at the observational study’s start was 6, meaning they could walk with an aid.

A total of 108 patients (47.6%) had complete disability data covering from treatment initiation to after one year of Mayzent’s use. During that period, 64.8% or 70 people maintained a stable EDSS score, 31.4% experienced disability progression (34 people), and 3.7% or four people saw their EDSS scores worsen without meeting the criteria for progression.

Notably, among stable patients, 21.4% had an easing in disability, and 30% showed no new lesions on brain scans

“Overall, at 12 months … no significant changes in the EDSS score were observed” among these 108 patients, the researchers wrote.

People with lower EDSS scores at the study’s start (baseline EDSS of 4 or less) remained stable, while those with higher baseline scores showed “a significant increase” over the year, they added.

A group of 41 patients, followed more in-depth for one year, also experienced no changes in cognitive abilities and motor function.

Side effects were reported in almost half of the patients (47.9%), with low levels of immune cells being the most common, followed by elevated liver enzymes, and high blood pressure.

“Interestingly, 26.8% of all patients reporting [an adverse event] continued therapy,” the researchers wrote.

Over the course of 18 months, almost one-third (31.2%) of all patients evaluated stopped taking Mayzent, mostly due to side effects, followed by disease progression. Vertigo was the most common side effect leading to treatment discontinuation.

“Treatment with siponimod had an overall stabilizing effect regarding clinical and radiological outcome measures,” the researchers concluded. However, “in light of our real-world efficacy and safety data, clinicians should be aware that patients must be closely monitored.”

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