Abstract Details

Title Pregnancy Outcomes in Patients With MS Following Exposure to Ofatumumab: Updated Results From the Novartis Safety Database

Topic Multiple Sclerosis

Presentation(s) P9 - Poster Session 9 (5:30 PM-6:30 PM)

Poster/Presentation
Number 3-014

Objective To report the latest cumulative outcomes in women with multiple sclerosis (MS) exposed to ofatumumab during or prior to pregnancy.

Background Ofatumumab, a fully human anti-CD20 monoclonal antibody with a monthly dosing s.c. regimen, is approved for treating relapsing MS (RMS) in adults. As per ofatumumab’s label, women of childbearing potential should use effective contraception during treatment and for at least 6 months after discontinuation of ofatumumab. Clinical data on the effect of ofatumumab treatment on pregnancy outcomes are currently limited.

Design/Methods The Novartis Safety Database collected cases from clinical trials as well as through a postmarketing pharmacovigilance non-interventional PRegnancy outcomes Intensive Monitoring (PRIM) study, where data from spontaneously reported pregnancies were collected using a set of targeted structured checklists. Pregnancy outcomes in women with MS exposed to ofatumumab during pregnancy or 6 months prior to last menstrual period (LMP) were analyzed and will be reported from the Novartis Safety Database (data cutoff date: September-25-2022). Pregnancy and infant outcomes including congenital anomalies, infections, vaccinations, and developmental delays were collected from the reporting of pregnancy up to 1 year of infant age.

Results

At prior cutoff date of March-25-2022, there were 61 exposed pregnancies with 30 known outcomes and 17 live births after maternal exposure to ofatumumab during pregnancy or 6 months prior to LMP. No congenital anomalies, reports of B-cell depletion, immunoglobulin/hematological abnormalities, or serious infections were reported. Updated pregnancy outcomes with a cutoff date of Sep-25-2022 from the Novartis Safety Database will be presented during the congress.

Conclusions Reporting the latest data on pregnancy outcomes after exposure to ofatumumab will provide updated information to healthcare professionals who treat people with MS of childbearing potential. In addition to the Novartis sponsored PRIM initiative, a prospective observational exposure registry on maternal and infant outcomes in patients exposed to ofatumumab is also currently underway.

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.
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.
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 .
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.
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 .
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.
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.
Ronald Zielman (Novartis)	No disclosure on file
	No disclosure on file
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.
Ulf Schulze Topphoff (Novartis Pharma)	Ulf Schulze Topphoff has received personal compensation for serving as an employee of Novartis Pharma GmbH.
Roseanne Sullivan (novartis)	Roseanne Sullivan has received personal compensation for serving as an employee of Novartis Pharmaceuticals. Roseanne Sullivan has stock in Novartis Pharmaceuticals.
	No disclosure on file
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 .

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