Ofatumumab Use in Women With Relapsing MS: What Are the Pregnancy Outcomes?

Maternal and neonatal outcomes were assessed among women with relapsing multiple sclerosis (RMS) receiving ofatumumab. These data were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024, held from February 29 to March 2, in West Palm Beach, Florida.

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) state that women of childbearing potential wait at least 6 months to get pregnant after discontinuation of ofatumumab treatment. However, pregnancy outcomes data in women with RMS receiving ofatumumab are limited.

Using a pharmacovigilance system (Novartis Safety Database) that includes clinical trial and postmarketing data from the Pregnancy Outcomes Intensive Monitoring (PRIM) study, researchers of the current analysis reported on pregnancy outcomes in women with RMS receiving ofatumumab. Outcomes included congenital anomalies, infections, vaccinations, and developmental delays.

The researchers collected data from women with RMS receiving treatment with ofatumumab during pregnancy or 6 months prior to their last menstrual period for up to 12 months postpartum.

A total of 279 pregnancies identified from the database had exposure to ofatumumab, of which 55 cases with 57 neonatal outcomes (2 twin pregnancies) were known:

• 29 livebirths, with 1 minor malformation (congenital hydronephrosis) and 1 set of twins
• 12 pregnancy terminations due to Edwards syndrome/trisomy 18 (n=1) and other reasons (n=11)
• 4 ectopic pregnancies
• 11 spontaneous abortions
• 1 abortion for undisclosed reason

One of the study limitations was the lack of generalizability.

“Reporting the latest data on pregnancy outcomes following treatment with ofatumumab will provide updated information to healthcare profession,” the researchers concluded.