Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L03AB07) interferon beta-1a
interferon beta-1a
(L03AB08) interferon beta-1b
interferon beta-1b
(L03AX13) glatiramer acetate
glatiramer acetate
(L04AA31) teriflunomide
teriflunomide
(L04AX07) dimethyl fumarate
dimethyl fumarate
(L04AA27) fingolimod
fingolimod
(L04AA23) natalizumab
natalizumab
(L04AA36) ocrelizumab
ocrelizumab
(L04AA34) alemtuzumab
alemtuzumab
(L01BB04) cladribine
cladribine

Medical condition to be studied

Multiple sclerosis
Population studied

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)

Estimated number of subjects

3000
Study design details

Main study objective

- To estimate the population-based yearly prevalence, incidence, and consumption of disease modifying therapies (DMTs), - To describe the treatment patterns of DMTs in Multiple sclerosis patients, - To estimate the impact of demographic and clinical characteristics on the relationship between DMTs specific exposure and treatment patterns (i.e. switches, interruptions, and drug discontinuations)

Outcomes

- Prevalence, incidence, and consumption of disease modifying therapies (DMTs) in the study period, - Treatment patterns during follow-up: continuers, discontinuers, interrupters, switchers and mixed users.

Data analysis plan

- Incidence, prevalence, and consumption of DMTs use will be estimated yearly during the study period. - Subjects will be grouped according to the first DMT dispensed in the study period. Then, each subject will be defined according to their treatment patterns observed during the follow-up. Finally, demographic, and clinical characteristics at the index date, as well as treatment patterns observed during the follow-up, will be summarized through standard descriptive statistic for each drug group. - For each DMT new user, treatment patterns during the entire follow-up will be plotted by using the Sankey diagram. - Recurrent events models and time-varying variables will be used to estimate the impact of the demographic and clinical covariates on the relationship between DMTs specific exposure and study outcomes (discontinuation and switch/interruption). Results will be expressed as Hazard Ratio (HR) with 95% CI.