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5PSQ-083 Ofatumumab exposure until early pregnancy in a woman with relapsing-remitting multiple sclerosis: a case report

ejhpharm · 2026-03-18 · canonical JSON source

16 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance Relapsing-remitting multiple sclerosis (RRMS) often affects women of childbearing age. Disease-modifying therapies (DMTs) have improved prognosis but pose challenges when pregnancy is planned. Anti-CD20 therapies such as ofatumumab are effective; however, their safety during pregnancy remains uncertain. Regulatory agencies recommend discontinuation once pregnancy is confirmed due to the risk of B-cell depletion in neonates. Published data are scarce, mainly limited to individual case reports and registry updates, making each new case valuable for clinical decision-making.Aim and Objectives To describe the maternal and neonatal outcomes in a patient with RRMS exposed to ofatumumab until conception and early pregnancy.Material and Methods The patient was a 33-year-old woman, diagnosed with RRMS in 2012. She had previously received several DMTs (interferon beta-1a, natalizumab, alemtuzumab). Given disease stability, ofatumumab was initiated in June 2023. Treatment was well tolerated, with no relapses or magnetic resonance imaging (MRI) activity. The last injection was administered on 18 November 2024. The patient herself notified the Neurology and Hospital Pharmacy departments of her pregnancy on 19 December 2024 (approximately 2–3 weeks after conception). Ofatumumab was discontinued immediately following pharmacist and neurologist counselling. The patient underwent regular neurological and obstetric follow-up.Results The pregnancy was uneventful, with no clinical relapses or MRI activity reported. At 39 weeks of gestation, an urgent caesarean section was performed due to fetal distress. A healthy male infant was born in August 2025 (Apgar scores 9/10, normal anthropometric measurements, and no congenital malformations detected). Breastfeeding was initiated but discontinued after the first week. The mother restarted ofatumumab therapy postpartum without adverse events. Neonatal laboratory tests, including lymphocyte counts, were within normal ranges; no infections were observed during the early follow-up period.Conclusion and Relevance This case contributes to the limited evidence on ofatumumab use in women with MS planning pregnancy. Exposure limited to the preconception period and very early gestation was not associated with maternal disease reactivation, obstetric complications, or neonatal abnormalities. Nevertheless, current guidelines recommend discontinuation of ofatumumab once pregnancy is confirmed, and neonatal monitoring (especially B-cell counts and vaccination schedule) is advised. Reporting such cases to registries is crucial to strengthen evidence and guide clinical recommendations.Conflict of Interest No conflict of interest