好色先生

好色先生

Explore the latest content from across our publications
Join The AAN

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Pregnancy and Infant Outcomes in Women With Relapsing Multiple Sclerosis Following Exposure to Ofatumumab: Latest Evidence From the PRIM Study
Multiple Sclerosis
P11 - Poster Session 11 (11:45 AM-12:45 PM)
18-002
To report cumulative pregnancy and infant outcomes in women with multiple sclerosis (MS) treated with ofatumumab before or during pregnancy.
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.

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.
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). 

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.

Authors/Disclosures
Riley Bove, MD, FAAN (University of California, San Francisco)
PRESENTER 		Dr. Bove has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Bove has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Bove has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme-Sanofi. Dr. Bove has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Bove has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD-Serono. Dr. Bove has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cadenza. The institution of Dr. Bove has received research support from Biogen. The institution of Dr. Bove has received research support from Eli Lilly. The institution of Dr. Bove has received research support from Novartis. The institution of Dr. Bove has received research support from Roche Genentech.
Sharon Stoll, DO (Stoll Medical Group) Dr. Stoll has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for roche Genentech. Dr. Stoll has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech . Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for biogen. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for novartis. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for sanofi/genzyme. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Stoll has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Dr. Stoll has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics . Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono . Dr. Stoll has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Stoll has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for alexion. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono . Dr. Stoll has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Horizon. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for BMS. Dr. Stoll has stock in BeCare Link LLC. Dr. Stoll has stock in Global Consult MS .
Ruth Dobson (Queen Mary University London) The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. The institution of Ruth Dobson has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis . Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sandoz. Ruth Dobson has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Epionex. The institution of Ruth Dobson has received research support from NMSS. The institution of Ruth Dobson has received research support from MS Society UK . The institution of Ruth Dobson has received research support from BMA Foundation . The institution of Ruth Dobson has received research support from Biogen . The institution of Ruth Dobson has received research support from Merck . The institution of Ruth Dobson has received research support from Horne Family Charitable Trust . The institution of Ruth Dobson has received research support from MRC. The institution of Ruth Dobson has received research support from NIHR. Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Medscape . Ruth Dobson has received personal compensation in the range of $0-$499 for serving as a Speaker with Limbus. Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Neurology Academy .
Maria P. Amato, PhD (Ospedale Di Careggi) Dr. Amato has received personal compensation for serving as an employee of AOUCareggi. Dr. Amato has received personal compensation for serving as an employee of AOUCareggi. Dr. Amato has received personal compensation for serving as an employee of AOUCareggi. Dr. Amato has received personal compensation for serving as an employee of AOU Careggi. Dr. Amato has received personal compensation for serving as an employee of AOUCareggi. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi genzyme. The institution of Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene BMS. The institution of Dr. Amato has received research support from Merck. The institution of Dr. Amato has received research support from Biogen. The institution of Dr. Amato has received research support from Roche.
Vineetkumar Kharat, PhD Mr. Kharat has received personal compensation for serving as an employee of Novartis Pharmaceuticals. Mr. Kharat has stock in Novartis Pharmaceuticals.
Anil Abeyewickreme, MD, PhD Dr. Abeyewickreme has received personal compensation for serving as an employee of Novartis Pharmaceuticals.
Valentine Jehl (Novartis) Valentine Jehl has received personal compensation for serving as an employee of Novartis Pharma AG. Valentine Jehl has stock in Novartis. Pharma AG.
Ivana Kramarikova, PhD Mrs. Kramarikova has nothing to disclose.
Bassem I. Yamout, MD, FAAN (Harley Street Medical Center) Dr. Yamout has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Yamout has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Yamout has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Yamout has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Yamout has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi.
Kristen M. Krysko, MD (St. Michael's Hospital) Dr. Krysko has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Krysko has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Krysko has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Krysko has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Krysko has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Krysko has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. The institution of Dr. Krysko has received research support from MS Society of Canda. The institution of Dr. Krysko has received research support from Roche.
Sandra Vukusic, MD (Hopital Neurologique Pierre Wertheimer) The institution of Dr. Vukusic has received research support from Biogen. The institution of Dr. Vukusic has received research support from Janssen. The institution of Dr. Vukusic has received research support from Merck. The institution of Dr. Vukusic has received research support from Novartis. The institution of Dr. Vukusic has received research support from Roche.
Kerstin Hellwig (St. Josef Hospital Bochum) Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mylan . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche . The institution of Kerstin Hellwig has received research support from Roche . The institution of Kerstin Hellwig has received research support from Merck . The institution of Kerstin Hellwig has received research support from Biogen. The institution of Kerstin Hellwig has received research support from Genzyme . The institution of Kerstin Hellwig has received research support from Novartis . The institution of Kerstin Hellwig has received research support from BMS .