A Real-world Study About the Impact of Siponimod Treatment on Secondary Progressive Multiple Sclerosis Patients in Russia (EMBOSSES)

Retrospective, Multicenter, Non-interventional (Observational) Study With the Aim to Describe the Impact of Siponimod Treatment in a Real-world SPMS Population in Russia

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 Overview

• Status: Completed
• Conditions: Secondary Progressive Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 606

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, non-interventional cohort study.

Description

Inclusion criteria:

• Documented diagnosis of SPMS, with or without relapses.
• Treatment with siponimod for at least 6 months.

Exclusion criteria:

None.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Siponimod Cohort; Adult patients with SPMS who were treated with siponimod.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics: Number of Patients by Age		Baseline
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	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	Baseline
Number of Patients Categorized by Type of Treatment Received Before Initiation of Siponimod	Treatment categories included glucocorticosteroids, cytostatics, and disease-modifying treatments (DMTs).	Baseline
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
Duration of Siponimod Therapy		Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Months 6, 12, 18, 24
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	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)	Months 6, 12, 18, 24
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Actual): September 26, 2024
• Study Completion (Actual): September 26, 2024

Study Registration Dates

• First Submitted: September 4, 2025
• First Submitted That Met QC Criteria: September 4, 2025
• First Posted (Estimated): September 11, 2025

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Siponimod; Treatment of multiple sclerosis; Real-world clinical data
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pathological Conditions, Signs and Symptoms; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive
• Other Study ID Numbers: CBAF312ARU02