Kesimpta Pregnancy and Infant Safety Study Using Real World Data

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) duringthe inclusion period

• Age 18-49 years at index date

• A diagnosis of MS before the index date. This inclusion criterion is based ondiagnosis codes, as recorded in the different data sources

• Availability of information on exposure to MSDMDs and maternal baselinecharacteristics 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 atleast one live birth

• For analyses of spontaneous abortion, elective termination of pregnancy, stillbirth,preeclampsia, eclampsia (secondary objectives): pregnancy ending in at least onelive birth, spontaneous abortion, elective termination, stillbirth, or ectopicpregnancy

• For analyses of preterm birth, SGA (secondary objectives): pregnancy ending in atleast one live birth

• For analyses of MCMs among live births, spontaneous abortions, stillbirths, andelective terminations (exploratory objective): pregnancy ending in at least one livebirth, 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 basedon the date of prescription, estimated supply duration, and the drug-specific windowof clearance

• Pregnancy exposed to a non-MSDMD that have a known moderate to high teratogeniceffect, determined based on the date of prescription, estimated supply duration, andthe 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 ofa chromosomal abnormality or a genetic syndrome

• For analyses of preterm birth, pre-eclampsia, eclampsia and SGA, pregnanciesinvolving multiples

• For Kesimpta and MSDMD-exposed cohorts: pregnancies not exposed during the outcomespecific risk period