Pregnancy Outcomes in Patients With MS Following Exposure to Ofatumumab: Updated Results From the Novartis Safety Database
Riley Bove1, Maria Pia Amato2, Ruth Dobson3, Kristen M. Krysko4, Sharon Stoll5, Sandra Vukusic6, Bassem Yamout7, Ronald Zielman8, Swetha Krishna Gummuluri9, Valentine Jehl10, Ulf Schulze Topphoff11, Roseanne Sullivan12, Simone Fantaccini10, Kerstin Hellwig13
1UCSF Weill Institute for Neuroscience, University of California San Francisco, San Francisco, California, USA, 2Department NEUROFARBA, University of Florence, Florence, Italy; IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy, 3Preventive Neurology Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, United Kingdom; Department of Neurology, Royal London Hospital, Barts Health NHS Trust, London, United Kingdom, 4Division of Neurology, Department of Medicine, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, Ontario, Canada, 5Department of Neurology, Yale University, New Haven, Connecticut, USA, 6Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation, Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon, France; Centre des Neurosciences de Lyon, INSERM 1028 et CNRS UMR5292, Observatoire Français de la Sclérose en Plaques, Lyon, France; Université Claude Bernard Lyon 1, Villeurbanne, France, 7American University of Beirut Medical Center, Beirut, Lebanon; Harley Street Medical Centre, Abu Dhabi, UAE, 8Novartis Pharma B.V., Amsterdam, The Netherlands, 9Novartis Healthcare Pvt Ltd, Hyderabad, India, 10Novartis Pharma A.G. Basel, Switzerland, 11Novartis Pharma GmbH, Germany, 12Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA, 13St. Josef-Hospital/Ruhr-University Bochum, Bochum, Germany
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.