Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

INTERFERON BETA-1A
INTERFERON BETA-1B

Anatomical Therapeutic Chemical (ATC) code

(L03AB07) interferon beta-1a
interferon beta-1a
(L03AB08) interferon beta-1b
interferon beta-1b
(L03AB13) peginterferon beta-1a
peginterferon beta-1a

Medical condition to be studied

Multiple sclerosis
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)

Special population of interest

Pregnant women

Estimated number of subjects

100
Study design details

Main study objective

To determine the number of pregnancies exposed to IFNB during late pregnancy, the 2nd and 3rd trimesters, in Finland and Sweden.
This informs whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.

Outcomes

1. The number of pregnancies of women with MS exposed to IFNB before and during pregnancy, not allowing exposure to other MS Disease Modifying Drugs (MSDMDs)
2. The level of precision for the risk of pre-defined adverse pregnancy outcomes in late pregnancy that can be obtained with the available number of pregnancies
3. The annual number of pregnancies of women with MS in the exposure groups:
a) The number of pregnancies of women with MS in Finland and Sweden allowing exposure to other MSDMDs
b) The annual number of women with MS of childbearing age, and with dispensed IFNB in 2015-2022

Data analysis plan

Analyses will be descriptive and exclusively categorical variables are included. The categorical variables will be summarised as numbers of women and pregnancies and as proportions of the relevant denominator.
The following will be reported:
1. The number of pregnancies by exposure status, without allowing exposure to other MS Disease Modifying Drugs (MSDMDs) than IFNB, by calendar year of last menstrual period (LMP) and during the study period.
2. The number of pregnancies in the late pregnancy only exposed group with and without the composite adverse pregnancy outcome consisting of stillbirths, spontaneous abortions, and elective terminations.
3. The number of pregnancies by exposure status, regardless of exposure to other MSDMDs, by calendar year of LMP and during the study period.
4. The number of women dispensed IFNB who have been diagnosed with MS and are of childbearing age during the full study period (reference population).