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196 Pregnancy and infant outcomes in women with MS receiving ocrelizumab: analysis of ~4,000 pregnancies

jnnp · 2025-11-26 · canonical JSON source

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

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The aim of this study is to report pregnancy and infant outcomes in women with MS exposed to ocrelizumab before or during pregnancy and/or breastfeeding.Pregnancies from the Roche safety database were analysed. Maternal ocrelizumab exposure was defined as ≥1 infusion; in utero exposure was defined as an infusion ≤3 months prior to the last menstrual period (LMP) or during pregnancy. Major congenital anomalies (MCA) were classified via EUROCAT 1.5.As of 28 March 2024, 3,989 cumulative MS pregnancies were reported; A total of 1,000 prospective pregnancies were considered in utero exposed. In utero exposed and non-exposed groups with known outcomes had similar proportions of live births (LB) (85.8% vs 89.2%), including preterm (8.5% vs 8.1%) LB, and spontaneous abortion (6.9% vs 8.4%). The proportion of LB with MCA was similar between the exposed and non-exposed group (1.8% vs 1.5%) and remained within epidemiological background.In utero exposure to ocrelizumab, primarily occurring ≤3M before the LMP and first trimester, did not increase the risk of adverse pregnancy or infant outcomes. Counselling remains important to ensure optimal outcomes for mothers and infants.ruth.dobson@qmul.ac.uk