Real-world siponimod use in secondary progressive multiple sclerosis: the RESYZE study.

BACKGROUND

Siponimod is approved in Europe for active secondary progressive multiple sclerosis (SPMS), but real-world data on its treatment patterns and outcomes in people with SPMS (pwSPMS) is limited.

OBJECTIVE

To assess the demographic and clinical characteristics, effectiveness, and safety of siponimod in pwSPMS in a real-world setting.

DESIGN

Non-interventional/observational, retrospective, multicenter study (28 centers).

METHODS

Patients (⩾18 years) with active SPMS treated with siponimod in routine care were included. Retrospective clinical, radiological, and laboratory data were collected for patients up to 24 months before and 12 months after siponimod treatment.

RESULTS

In total, 210 participants were included (mean age: 52.5 ± 8.6 years; females: 71.0%). At treatment initiation, the mean Expanded Disability Status Scale (EDSS) score was 5.7 ± 1.2. The mean time since multiple sclerosis diagnosis and the median time since active SPMS diagnosis were 16.7 ± 8.9 years and 1.3 (0.3; 4.4) years, respectively. Common comorbidities included psychiatric disorders and dyslipidemia (20.6%, each). Regarding working status, 55.9% with available information showed incapacity for work. Prior to siponimod, 44.3% received highly effective therapies: fingolimod (20.5%), rituximab (9.5%), ocrelizumab (5.2%), natalizumab (4.8%), and alemtuzumab (2.4%). After 1 year, 82.8% of the patients remained stable in terms of disability progression, 94.3% were free of relapses, and 85.7% did not present radiological disease activity; 46.2% experienced adverse events, 8.6% experienced serious adverse events, and 26 (12.4%) patients discontinued permanently.

CONCLUSION

In the study cohort, pwSPMS had high disability scores and comorbidities; more than half were unable to work, and over 40% had previously received high-efficacy therapies. After 1 year of siponimod treatment, most pwSPMS showed no signs of disease activity, with stabilized EDSS scores and relapses and new T2 or gadolinium-T1 lesions, as well as a favorable safety profile.