Study Description
The study is an observational retrospective cohort study using longitudinal secondary
data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease
modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes. Outcomes among Kesimpta exposed pregnancies are compared primarily to MSDMD-exposed
pregnancies and secondarily to MSDMD-unexposed pregnancies.
The main research question is to determine whether the exposure during pregnancy to
Kesimpta increases the risk of adverse pregnancy and infant outcomes in women with MS.
The risk period is defined as the 1st trimester of pregnancy for analyses of Major
congenital malformations and the entire duration of pregnancy for all other outcomes.
The data for this study is retrieved from data sources from Denmark, Sweden, and the US,
based on an assessment of feasibility.
Interventions
Multiple sclerosis disease modifying drug
Eligibility Criteria
Inclusion Criteria:
The following overall criteria for study inclusion are applied:
- Pregnancy with a recorded start and end of pregnancy outcome (live birth,
spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy) during
the inclusion period
- Age 18-49 years at index date
- A diagnosis of MS before the index date. This inclusion criterion is based on
diagnosis codes, as recorded in the different data sources
- Availability of information on exposure to MSDMDs and maternal baseline
characteristics for a minimum of 12 months before the index date
In addition, the following outcome and objective specific inclusion criteria are applied:
- For analyses of MCMs in live births (primary objective): pregnancy ending in at
least one live birth
- For analyses of spontaneous abortion, elective termination of pregnancy, stillbirth,
preeclampsia, eclampsia (secondary objectives): pregnancy ending in at least one
live birth, spontaneous abortion, elective termination, stillbirth, or ectopic
pregnancy
- For analyses of preterm birth, SGA (secondary objectives): pregnancy ending in at
least one live birth
- For analyses of MCMs among live births, spontaneous abortions, stillbirths, and
elective terminations (exploratory objective): pregnancy ending in at least one live
birth, spontaneous abortion, still birth, or elective termination
- For analyses of neonatal infection: live newborn
- For analyses of SII: newborn alive at 29 days after birth
Exclusion Criteria:
The following overall criteria for exclusion are applied:
- Pregnancy exposed to a MSDMD that have a known teratogenic effect, determined based
on the date of prescription, estimated supply duration, and the drug-specific window
of clearance
- Pregnancy exposed to a non-MSDMD that have a known moderate to high teratogenic
effect, determined based on the date of prescription, estimated supply duration, and
the drug-specific window of clearance
The following outcome specific exclusion criteria are applied:
- For analyses of MCMs and exploratory analyses of MCMs: pregnancies with a record of
a chromosomal abnormality or a genetic syndrome
- For analyses of preterm birth, pre-eclampsia, eclampsia and SGA, pregnancies
involving multiples
- For Kesimpta and MSDMD-exposed cohorts: pregnancies not exposed during the outcome
specific risk period
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