Kesimpta Pregnancy and Infant Safety Study Using Real World Data

Novartis

Status

Enrolling

Conditions

Multiple Sclerosis

Treatments

Other: Multiple sclerosis disease modifying drug

Study type

Observational

Funder types

Industry

Identifiers

NCT06156683

COMB157G2405

EUPAS106133 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,500 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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