Secondary Progressive Multiple Sclerosis
Conditions
Brief summary
RESYZE was a non-interventional/observational, retrospective, multi-center study conducted in 28 public and private hospitals in Spain, assessing secondary progressive multiple sclerosis (SPMS) patients in a real-world setting. Patients underwent clinical assessments and received their standard routine medical care, as determined by their treating physicians. The study used secondary data i.e., electronic medical records (EMR) from hospitals. Patients who met the eligibility criteria were selected from the EMR of each of the sites, to include adult SPMS diagnosed patients who received at least one dose of siponimod during the start of treatment period between April 2021 and 01 September 2022, with a 12-month observation period, regardless of whether or not they continued the treatment. The study compiled data that was available in the hospital EMR from each patient up to 24 months before the first siponimod dose, and 12 months after the first siponimod dose. Data were collected for each patient at regular intervals of 6/12 months and within a window period of ±45 days, as available.
Interventions
None listed
Sponsors
Novartis
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with SPMS, as diagnosed by a physician, who started siponimod treatment at least 12 months before (during the start of the treatment period: from April 2021 to September 2022), regardless of whether they continued treatment or they did not. * Patients who received at least 1 dose of siponimod treatment for SPMS with a 12-month observation period. * Availability of the data for at least 12 months after siponimod initiation.
Exclusion criteria
* Patients with any contraindication to siponimod, according to applicable Summary of Product Characteristics (SmPC). * Patients included in any clinical trial at any moment of the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients by Number of Relapses in the 24 Months Before Starting Siponimod Treatment | Baseline | — |
| Number of Patients by Education Status | Baseline | Education status included: * No studies * Primary education * Secondary education * Superior education * Unknown or missing |
| Number of Patients by Working Status | Baseline | Working status included: * Full-time * Part-time * Retired * Incapacity for work * Medical leave * Unemployed * Student * Unknown or missing |
| Body Mass Index (BMI) | Baseline | — |
| Number of Patients by Smoking Habit | Baseline | Smoking habits included: * Non-smoker * Smoker * Ex-smoker * Unknown or missing |
| Number of Patients by Alcohol Consumption | Baseline | Alcohol consumption categories included: * High risk consumer * Low risk consumer * Teetotaler * Unknown or missing |
| Number of Patients by Cytochrome P450 Family 2 Subfamily C Member 9 (CYP2C9) Genotype | Baseline | Genotype variants included: * CYP2C9\*1\*1 * CYP2C9\*1\*2 * CYP2C9\*1\*3 * CYP2C9\*2\*2 * CYP2C9\*2\*3 * Other |
| Time Since Multiple Sclerosis (MS) Diagnosis | Baseline | — |
| Time Since Secondary Progressive Multiple Sclerosis (SPMS) Diagnosis | Baseline | — |
| Number of Patients by Number of Relapses in the 12 Months Before Starting Siponimod Treatment | Baseline | — |
| Number of Patients by Number of Gadolinium T1 (Gd-T1) Lesions 24 Months Before Starting Siponimod Treatment | Baseline | — |
| Baseline Expanded Disability Status Scale (EDSS) Score at the Start of Siponimod Treatment | Baseline | The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS score. The scale ranges from 0 to 10, with 0 being normal neurological exam and 10 being death due to MS. |
| Number of Patients With Cognitive Decline Diagnosis | Baseline | — |
| EDSS Cognitive Subscale Score in Patients With Cognitive Decline | Baseline | The EDSS cognitive subscale is used to grade the decrease in mentation inside the Cerebral Functional System of the EDSS scale. The scale ranges from 0 to 5, with 0 being normal (no decrease in mentation) and 5 being dementia, confusion and/or complete disorientation. |
| Number of Patients by Comorbidity | Baseline | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients who Reported a Serious Adverse Event During Treatment With Siponimod | Up to 12 months | — |
| Number of Patients With Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment | Up to 12 months | — |
| Number of Patients With Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment | Up to 12 months | — |
| Number of Patients With Serious Adverse Events Which Led to Permanent Discontinuation of Siponimod Treatment | Up to 12 months | — |
| Number of Patients With Serious Adverse Events Which Led to Temporary Discontinuation or Dose Adjustment of Siponimod Treatment | Up to 12 months | — |
| Number of Patients Who Died During Treatment With Siponimod | Up to 12 Months | — |
| Number of Patients by Lymphopenia Grade During Treatment With Siponimod | Baseline, Month 6, Month 12 | Lymphopenia grades: * Grade 1: less than lower limit of normal to 800 cells per cubic millimeters (cells/mm\^3) * Grade 2: less than 800 to 500 cells/mm\^3 * Grade 3: less than 500 to 200 cells/mm\^3 * Grade 4: less than 200 cells/mm\^3 |
| Number of Patients With Confirmed Disability Progression During Treatment With Siponimod | Up to 12 months | Confirmed Disability Progression was determined by an increase of at least 1 point in the Expanded Disability Status (EDSS) score if the baseline EDSS was 5.5 or less, or an increase of 0.5 points in the EDSS score if the baseline EDSS score was greater than 5.5 confirmed in a second visit performed at least 3 months apart. The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS scores, ranging from 0 (normal) to 10 (death due to MS). |
| Time to First Relapse | Up to 12 months | — |
| Number of Patients Free From Relapses During the 12 Months of Treatment With Siponimod | 12 months | — |
| Number of Patients With Radiologically Detected MS Disease Activity During Treatment With Siponimod | Up to 12 months | — |
| Number of Patients With New Gd-T1 Lesions Detected After Treatment With Siponimod | Up to 12 months | — |
| Number of Patients With New or Enhanced T2 Lesions Detected After Treatment With Siponimod | Up to 12 months | — |
| Number of Patients who Discontinued Siponimod Treatment | Up to 12 months | — |
| Number of Patients by COVID-19 Vaccination Status at the Moment of COVID-19 Infection | Up to 12 months | Vaccination status included vaccinated and not vaccinated. |
| Number of Patients who Required Hospitalization due to COVID-19 Infection During the Study | Up to 12 months | — |
| Number of Patients With COVID-19 During the Study | Up to 12 months | — |
| Number of Patients by Type of Siponimod Treatment Discontinuation | Up to 12 months | Treatment discontinuation categories included temporal and permanent discontinuation. |
| Number of Patients by Reason for Temporal Discontinuation of Siponimod Treatment | Up to 12 months | — |
| Number of Patients by Reason for Permanent Discontinuation of Siponimod Treatment | Up to 12 months | — |
| Number of Patients Who Started a New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment | Up to 12 months | — |
| Number of Patients by New Disease Modifying Treatment After Permanent Discontinuation of Siponimod Treatment | Up to 12 months | — |
| Number of Patients Who Received Concomitant Treatment for Symptomatic Treatment of MS | Up to 12 months | — |
| Number of Patients by Type of Concomitant Treatment Received for Symptomatic Treatment of MS | Up to 12 months | — |
| Number of Patients by Maintenance Siponimod Dose | Up to 12 months | Maintenance siponimod doses included 1 milligram (mg) and 2 mg. |
| Number of Patients who Needed a Siponimod Dose Modification | Up to 12 months | — |
| Number of Patients by Reason for Siponimod Dose Modification | Up to 12 months | — |
| Number of Patients who Needed First Dose Observation | Day 1 of the 12-month observation period | — |
| Number of Patients who Reported an Adverse Event During First Dose Observation | Day 1 of the 12-month observation period | — |
| Number of Patients who Reported an Adverse Event During Treatment With Siponimod | Up to 12 months | — |
| Number of Patients who Reported an Adverse Event of Special Interest During Treatment With Siponimod | Up to 12 months | Adverse events of special interest included: * Lymphopenia * Macular edema * Bradyarrhythmia * Atrioventricular blockage * Hypertension * Hepatic enzymes elevation * Epileptic crisis * Infections * Cutaneous neoplasia * COVID-19 * Death * Other |
Countries
United States
Outcome results
None listed