Pregnancy and Infant Outcomes in Women With Relapsing Multiple Sclerosis Following Exposure to Ofatumumab: Latest Evidence From the PRIM Study
Riley Bove1, Sharon Stoll2, Ruth Dobson3, Maria Amato4, Vineetkumar Kharat5, Anil Abeyewickreme6, Valentine Jehl7, Ivana Kramarikova7, Bassem Yamout8, Kristen Krysko9, Sandra Vukusic10, Kerstin Hellwig11
1UCSF Weill Institute for Neurosciences, San Francisco, 2Advocare, Stoll Medical Group, Philadelphia, 3Wolfson Institute of Population Health, 4University of Florence, 5Novartis Pharmaceuticals Corporation, 6Novartis Pharmaceuticals UK Ltd., 7Novartis Pharma AG, 8Harley Street Medical Center, 9St. Michael's Hospital, 10Lyon University Hospital, 11St. Josef Hospital/Ruhr University Bochum
Objective:
To report cumulative pregnancy and infant outcomes in women with multiple sclerosis (MS) treated with ofatumumab before or during pregnancy.
Background:
Current labeling indicates that women of childbearing potential use effective contraception during ofatumumab treatment and for at least 6 months after treatment discontinuation. However, pregnancies may occur during this interval.
Design/Methods:
Pregnancy and infant outcomes were analyzed from the Novartis non-interventional PRegnancy outcomes Intensive Monitoring (PRIM) program in women with MS administered ofatumumab during pregnancy or up to 180 days prior to their last menstrual period (LMP) (data cutoff: 03/25/2025). Prevalences (%) were estimated in cases reported prior to 03/25/2024, providing ≥1 year post initial reporting to allow any pregnancy outcomes to occur.
Results:
Cumulatively, until 03/25/2025, 906 prospective pregnancy cases were identified. There were 415 cases with ≥1 year since initial reporting; 88% of cases with available administration timing were during the first trimester, and outcome was known for 232 cases. These included 180 (78%) live births, 16 (7%) induced terminations (including 1 termination due to fetal anomaly [TOPFA] [cerebral malformation/acrania]), 33 (14%) spontaneous abortions, 0 (0%) abortion not otherwise specified, 1 (0.4%) stillbirth, and 2 (1%) ectopic pregnancies. Cumulatively, congenital anomalies were reported in 8 infants: major for 5 infants (1.7%, 95%CI: 0.5–3.8) and minor for 3 infants (1%, 95%CI: 0.2–2.9) among the known fetal outcomes cohort (denominator: live births, stillbirths and TOPFA). Major malformations included urinary (3 infants), heart defect (2 infants), and nervous system (1 infant where the pregnancy was terminated). Additionally, 3 cases of chromosomal anomaly/genetic disorder were reported (1 in a live birth and 2 in induced terminations, excluded from major congenital anomalies).
Conclusions:
Pregnancy outcomes following maternal ofatumumab administration during pregnancy or up to 180 days prior to LMP are in line with expected background rates in the general population.
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