Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data
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.
⁃ 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