Real-world siponimod use in secondary progressive multiple sclerosis: the RESYZE study.
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Oreja-Guevara Celia, Gómez-Estévez Irene, Agüado García Laura, Martín Martínez Jesus, Gómez Gutiérrez Montserrat, Gascón Giménez Francisco, Agüera Morales Eduardo, Meca-Lallana Virginia, Barrero Hernández Francisco Javier, González Quintanilla Vicente, Romero Pinel Lucía, Delgado Gil Virginia, Durán Ferreras Eduardo, Blasco Quílez Rosario, Meca-Lallana Jose, Landete Pascual Lamberto, Aladro-Benito Yolanda, Boyero Durán Sabas, Gracia Gil Julia, Caminero Rodríguez Ana Belén, Cano Orgaz Antonio Tomás, Eichau Madueño Sara, Querol Pascual María Rosa, Otano Martínez María, Alonso Torres Ana María, Calles Hernández Carmen, López Real Ana, Ares Luque Adrián, Lorenzo González Jose Ramón, Gómez Vicente Lidia, Díaz Sánchez María
Аннотация
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.