DMT35
Pregnancy Outcomes in Ofatumumab-Treated Patients with Multiple Sclerosis

Thursday, June 2, 2022
Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)
Kerstin Hellwig, MD , Department of Neurology, St Josef Hospital, Ruhr University, Bochum, Germany
Bassem Yamout, MD , Harley Street Medical Center, Abu Dhabi, United Arab Emirates
Riley Bove, MD , University of California San Francisco, San Francisco, CA
Krishna Swetha Gummuluri, MBBS, Dip. Pharm. Med , Novartis Healthcare Pvt. Ltd., Hyderabad, India
Ulf Schulze Topphoff, PhD , Novartis Pharma GmbH, Nuremberg, Germany
Simone Fantaccini, MD , Novartis Pharma A.G., Basel, Switzerland
Ronald Zielman, MD, PhD , Novartis Pharma B.V., Amsterdam, Netherlands
Roseanne Sullivan, PharmD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Maria Pia Amato, MD , Department NEUROFARBA, University of Florence, Florence, Italy, IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy
Ruth Dobson, PhD, FRCP , Department of Neurology, Royal London Hospital, BartsHealth NHS Trust, London, United Kingdom, Preventative Neurology Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom
Maria Houtchens, MD , Brigham Multiple Sclerosis Center, Brigham and Women's Hospital, Harvard Medical School, Boston, MA
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Background: Ofatumumab, a fully human anti-CD20 monoclonal antibody with a 20 mg subcutaneous monthly dosing regimen, is approved for treating relapsing multiple sclerosis (RMS) in adults. As per ofatumumab’s label, women of childbearing potential should use effective contraception during and for at least 6 months after discontinuation of ofatumumab treatment. Data on the effect of ofatumumab on pregnancy outcomes are currently limited in humans.

Objectives: To report the cumulative outcomes of pregnancy in women with RMS inadvertently exposed to ofatumumab during or prior to unplanned pregnancy from the Novartis Safety Database

Methods: Pregnancy outcomes in women with RMS exposed to ofatumumab during pregnancy or 6 months prior to last menstrual period will be analyzed from the Novartis Safety Database (includes cases from clinical trials and the post-marketing setting; data cut-off: Mar-25-2022). Maternal and infant outcomes including congenital anomalies, infections, vaccination, and developmental delay are being collected from the reporting of pregnancy up to 1 year of infant age.

Results: As presented previously with a cut-off date of Aug-31-2021, no congenital anomalies were reported in pregnant women exposed to ofatumumab during pregnancy or 6 months prior to last menstrual period and no reports of B-cell depletion, Immunoglobulin/hematological abnormalities, or serious infections in live births were reported. Updated pregnancy outcomes with a cutoff: Mar-25-2022 from clinical trials and post-marketing setting will be presented during the congress.

Conclusions: Reporting the latest data on pregnancy outcomes in women with exposure to ofatumumab will be helpful to healthcare professionals when treating MS in women of childbearing potential. A prospective observational registry on maternal and infant outcomes in women exposed to ofatumumab is also currently underway.

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