Patients with secondary progressive multiple sclerosis (MS) receiving treatment with siponimod  (Mayzent®) appear to have sustained clinical stability after a 1-year follow-up period, according to a recently published study in Neurological Research and Practice.   

Although immune-modulating therapies have shown promising results in relapsing-remitting multiple sclerosis, progressive forms of multiple sclerosis (MS) seem to benefit significantly less from these alternatives and remain a therapeutic challenge, reported Liesa Regner-Nelke, of the University Hospital Düsseldorf in Germany, and colleagues.

Siponimod, a new-generation sphingosine-1-phosphate receptor modulator, was effective in reducing the risk of 3-month confirmed disability progression in the EXPAND trial. However, the cohort included in the trial is not representative of real-world populations, the researchers added.


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“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 authors wrote. 

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Therefore, the study team aimed to investigate the safety and efficacy of siponimod in a real-world cohort of patients with secondary progressive MS through a retrospective, noninterventional, multicenter study. The study included over 220 patients with secondary progressive MS receiving siponimod treatment in Germany.

The Expanded Disability Status Scale (EDSS), magnetic resonance imaging findings, and relapse were used to measure disease progression. To assess safety, the authors recorded all adverse effects and reasons for treatment discontinuation. Data was collected in 6-month intervals until 18 months.  

The median EDSS at the beginning of the trial was 6 and the mean number of relapses prior to siponimod treatment ranged between 1 and 3. After a 1-year follow-up period, over 60% of patients had no significant disease progression. Of those, approximately 20% showed improvement. About 30% of patients experienced disease progression. 

“Surprisingly, when considering less severely affected patients with an EDSS of 4 or lower in our cohort, we observed a slight but significant EDSS worsening after 12 months of treatment compared to baseline,” the authors wrote. 

Only 20% of patients had evidence of radiological progression after 6 months of treatment, and after 12 months, the percentage rose to 29%. Of this group, no patients presented with significant disease progression after an 18-month follow-up period. Motor function and cognitive abilities were intact as well.

Adverse effects were reported in over half of the patients. The most common adverse effect was lymphopenia in nearly 40% of patients, followed by elevated liver enzymes (20%) and arterial hypertension (16%). Approximately 30% of patients discontinued therapy, with the main reason being the presence of neurological adverse effects such as vertigo.

“Future long-term real-world studies will provide more clarity as to exactly which patients will benefit from the siponimod treatment,” the authors wrote. 

Reference

Regner-Nelke L, Pawlitzki M, Willison A, et al. Real-world evidence on siponimod treatment in patients with secondary progressive multiple sclerosis. Neurol Res Pract. Published online November 7, 2022. doi:10.1186/s42466-022-00219-3