Abstract Details

Title Pregnancy Outcomes in Patients with Multiple Sclerosis Following Exposure to Ofatumumab

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-007

Objective

Report pregnancy outcomes from the Novartis Safety Database (NSD) in women with RMS inadvertently exposed to ofatumumab during pregnancy.

Background

As per the ofatumumab label, females of childbearing potential should use effective contraception during and for ≥6 months after discontinuation of treatment. Data on the effect of ofatumumab on pregnancy outcomes are limited in humans.

Design/Methods

Pregnancy outcomes data from women with RMS exposed to ofatumumab during pregnancy or 6 months prior to last menstrual period were analyzed from clinical trials, and real-world setting in the NSD (cutoff: August 31, 2021). Maternal and infant outcomes including birth defects, congenital anomalies, infections, vaccination, and developmental delays were collected from the reporting of pregnancy up to 1 year of infant age.

Results

As of cutoff date, 32 pregnancies with ofatumumab (ASCLEPIOS I/II, n=4; ALITHIOS, n=14; MIRROR, n=7; post-marketing, n=7) were reported in women with MS; of which 5 were ongoing and in 4 pregnancies, information on the outcomes was not reported. The remaining 23 pregnancies had the following outcomes: therapeutic/induced abortions (n=6), spontaneous abortion (n=5), early intrauterine fetal demise at ~8.5 weeks gestation and patient underwent therapeutic abortion (n=1; not suspected to be related to ofatumumab by the treating physician), and 11 live births of normal babies. Based on followed-up data (up to 1 year of infant age), no B-cell depletion, immunoglobulin/hematological/fetal abnormalities, and serious infections were reported.

Conclusions

In this analysis, no birth defects or congenital anomalies were reported in 23 pregnant women exposed to ofatumumab with known outcomes. There were no reports of B-cell depletion, immunoglobulin/hematological abnormalities, or serious infections in live births to date. Sharing the up-to-date data on pregnancy and infant outcomes with ofatumumab is helpful in counseling women with MS of childbearing potential. A prospective observational registry on maternal and infant outcomes in women exposed to ofatumumab is currently being planned.

Authors/Disclosures
Kerstin Hellwig (St. Josef Hospital Bochum) PRESENTER	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 .
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.
Riley Bove, MD, FAAN (University of California, San Francisco)	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.
	No disclosure on file
Ulf Schulze Topphoff (Novartis Pharma)	Ulf Schulze Topphoff has received personal compensation for serving as an employee of Novartis Pharma GmbH.
Dee Stoneman (Novartis AG)	Dee Stoneman has received personal compensation for serving as an employee of Novartis.
Ronald Zielman (Novartis)	No disclosure on file
	No disclosure on file
Maria K. Houtchens, MD	Dr. Houtchens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche . Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Houtchens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Serono. Dr. Houtchens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Cravath. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Beasley . Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Biogen. The institution of Dr. Houtchens has received research support from Genzyme. The institution of Dr. Houtchens has received research support from Biogen. The institution of Dr. Houtchens has received research support from Genentech. The institution of Dr. Houtchens has received research support from Novartis.

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