Pregnancy and infant outcomes in women receiving ocrelizumab: analysis of over 3,000 pregnancies

<h3>Objectives</h3> Evaluate Roche safety database reported pregnancies/infant outcomes in women with multiple sclerosis (MS) receiving ocrelizumab (OCR). <h3>Methods</h3> Maternal exposure: receiving ≥1 OCR infusion; in utero fetal exposure: last infusion occurring within 3 months prior to LMP/during pregnancy. Fetal death termed spontaneous abortion (SA) &lt;22 gestational weeks (GW), or stillbirth (SB) if later. Live births (LB) were Preterm &lt;37 GW. Major congenital anomalies (MCA) classified via EUROCAT 1.5. <h3>Results</h3> 3,244 pregnancies reported by July 2023. 2,444 prospectively, 739 retrospectively, 7 unspecified. Of the 2,444 prospectively reported pregnancies, 855 (35.0%) had in utero exposure, 574 (23.5%) no in utero exposure, 1,015 (41.5%) unknown exposure. Outcomes for 1,144 prospectively reported pregnancies: 956 (83.6%) LB; 14 (1.2%) ectopic pregnancies (EP); 58 (6.2%) elective terminations (ET); 115 (10.2%) SA; 1 (&lt;0.1%) SB. Of 855 prospectively reported pregnancies exposed in utero, 512 known outcomes: 431 (84.2%) LB; 4 (0.8%) EP; 38 (7.4%) ET; 38 (7.4%) SA; 1 (0.2%) SB. Total of 16 (1.7%) MCAs in prospectively reported LB, 9 in utero exposure. <h3>Conclusions</h3> <i>In utero</i> OCR exposure did not increase the risk of adverse pregnancy or infant outcomes compared with previous reports as well as with epidemiologic background of both MS and general population.