Secondary Progressive Multiple Sclerosis
Conditions
Keywords
Siponimod, Treatment of multiple sclerosis, Real-world clinical data
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of SPMS, with or without relapses. * Treatment with siponimod for at least 6 months.
Exclusion criteria
None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Siponimod Therapy | Up to 2 years | — |
| Demographics: Number of Patients by Gender | Baseline | — |
| Time Between MS Diagnosis and Treatment Initiation | Baseline | — |
| Time Between SPMS Diagnosis and Treatment Initiation | Baseline | — |
| Time Between First Symptoms and Treatment Initiation | Baseline | — |
| Number of Patients by Clinical Characteristic Category | Baseline | 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 |
| Number of Patients Categorized by Type of Treatment Received Before Initiation of Siponimod | Baseline | Treatment categories included glucocorticosteroids, cytostatics, and disease-modifying treatments (DMTs). |
| Number of Patients by DMT Received Before Initiation of Siponimod | Baseline | — |
| Duration of the Washout Period After Other DMTs and Before Initiation of Siponimod | Baseline | — |
| Number of Patients by Reason for Switching From Other DMTs to Siponimod | Baseline | — |
| Demographics: Number of Patients by Age | Baseline | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Confirmed Disability Progression Over 6 Months (6m-CDP) Based on the EDSS Score | Months 6, 12, 18, 24 | 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. |
| Number of Patients With MS Relapses | Baseline | — |
| Annualized Relapse Rate (ARR) | 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 | 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 | Months 6, 12, 18, 24 | 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) |
| Number of Patients by Reason for Stopping Siponimod Treatment | Months 6, 12, 18, 24 | — |
| Number of Patients With Siponimod-related Adverse Events | Months 6, 12, 18, through study follow-up, up to approximately 24 months | — |
| Number of Patients With Siponimod-related Serious Adverse Events | Months 6, 12, 18, through study follow-up, up to approximately 24 months | — |
| Change From Baseline in Expanded Disability Status Scale (EDSS) Score | Baseline and Months 6, 12, 18, 24 | 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). |
Countries
United States
Outcome results
None listed