The main aim of the study was to describe the demographic and clinical characteristics of patients with secondary progressive multiple sclerosis (SPMS) who were receiving siponimod therapy in Russia. This study analyzed data from outpatient records/medical records collected across 11 Russian multiple sclerosis (MS) centers. Data collection was carried out from April 16, 2024 to September 26, 2024.
Study Type
OBSERVATIONAL
Enrollment
606
Novartis
East Hanover, New Jersey, United States
Demographics: Number of Patients by Age
Time frame: Baseline
Demographics: Number of Patients by Gender
Time frame: Baseline
Time Between MS Diagnosis and Treatment Initiation
Time frame: Baseline
Time Between SPMS Diagnosis and Treatment Initiation
Time frame: Baseline
Time Between First Symptoms and Treatment Initiation
Time frame: Baseline
Number of Patients by Clinical Characteristic Category
Clinical characteristics included: * MS symptoms * Magnetic resonance imaging (MRI) performed (yes/no) * Number of contrast-enhancing lesions on T1-weighted images (WI) (Gd+T1 lesions): absent, single, or multiple lesions * CYP2C9 isoenzyme genotype
Time frame: Baseline
Number of Patients Categorized by Type of Treatment Received Before Initiation of Siponimod
Treatment categories included glucocorticosteroids, cytostatics, and disease-modifying treatments (DMTs).
Time frame: Baseline
Number of Patients by DMT Received Before Initiation of Siponimod
Time frame: Baseline
Duration of the Washout Period After Other DMTs and Before Initiation of Siponimod
Time frame: Baseline
Number of Patients by Reason for Switching From Other DMTs to Siponimod
Time frame: Baseline
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Duration of Siponimod Therapy
Time frame: Up to 2 years
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
The EDSS is a tool used by doctors to measure disability in MS patients and monitor changes in the level of disability over time. It focuses on rating 7 functional systems: visual function, brainstem symptoms (speech, swallowing, rapid eye movement), pyramidal (muscle strength and movement), cerebellar (coordination and balance), sensory, bowel and bladder function, and higher cerebral functions (thinking and memory). These ratings are then used in conjunction with observations and information concerning gait and use of assistive devices to rate the EDSS. EDSS scores range from 0 (normal) up to 10 (death due to MS).
Time frame: Baseline and Months 6, 12, 18, 24
Percentage of Patients With Confirmed Disability Progression Over 6 Months (6m-CDP) Based on the EDSS Score
Confirmed disability progression is determined when a patient shows a sustained or increased EDSS score compared to the date of the first documented worsening of neurological function, assessed at least 6 months later, provided there are no relapses during the assessment period. A clinically meaningful worsening of neurological function is defined as an increase in EDSS score of 1.5 points for patients with a baseline EDSS of 0, 1.0 point for those with a baseline EDSS of 1.0 to 5.5, or 0.5 points for patients with a baseline EDSS of 6.0.
Time frame: Months 6, 12, 18, 24
Number of Patients With MS Relapses
Time frame: Baseline
Annualized Relapse Rate (ARR)
Time frame: 1 and 2 years before siponimod initiation and 6, 12, 18, and 24 months after siponimod treatment
Change in ARR From 1 Year Before Siponimod Initiation to 6, 12, 18, and 24 Months After Siponimod Treatment
Time frame: 1 year before siponimod initiation and 6, 12, 18, and 24 months after siponimod treatment
Number of Patients With MRI Signs of MS After Siponimod Treatment
MRI signs included: * Contrast-enhancing lesions on T1-WI (Gd+T1 lesions): absent, single, or multiple lesions * New/enlarged lesions on T2-WI or contrast-enhancing lesions on T1-WI (Gd+T1 lesions)
Time frame: Months 6, 12, 18, 24
Number of Patients by Reason for Stopping Siponimod Treatment
Time frame: Months 6, 12, 18, 24
Number of Patients With Siponimod-related Adverse Events
Time frame: Months 6, 12, 18, through study follow-up, up to approximately 24 months
Number of Patients With Siponimod-related Serious Adverse Events
Time frame: Months 6, 12, 18, through study follow-up, up to approximately 24 months