Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Retrospective, multicenter, observational study
Study drug and medical condition

Name of medicine

MAYZENT

Medical condition to be studied

Multiple sclerosis
Population studied

Short description of the study population

Adult patients with multiple sclerosis initiated treatment with Siponimod.
Inclusion criteria:
- Adult patients with active secondary progressive multiple sclerosis who have started treatment with Siponimod.
- At least three months of follow-up from the start of treatment.
- At least one analytical determination after the start of treatment with Siponimod.`

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Patients with multiple sclerosis

Estimated number of subjects

150
Study design details

Main study objective

To assess the incidence of haematological abnormalities, particularly lymphopenia related to siponimod treatment in patients with secondary progressive multiple sclerosis in the context of clinical practice.

Outcomes

Analytical data available in the clinical history: Leukocytes, Lymphocytes, ALT, AST, GGT, Alkaline Phosphatase (ALP) and Total Bilirubin. All serious adverse reactions (SAEs) related to the study drugs will be collected and recorded by the physicians responsible for, - Determine the clinical significance of lymphopenia produced by siponmod - Identify possible demographic, clinical or therapeutic factors related to the development of lymphopenia in the context of the use of siponimod. - Describe the safety of siponimod in the context of clinical practice

Data analysis plan

A descriptive analysis will be carried out for all the variables of the study, with the appropriate analyzes depending on the nature of each of the variables. Logistic regression models will be used to identify predictors of lymphopenia and serious adverse events. The adjusted OR will be estimated for comorbidities and other treatments that the patient had taken. A multivariate logistic regression analysis by stages will be used to identify any independent baseline factors that predicted the absence of response or the development of adverse events.