Reported pregnancies among women with MS treated with OCR rose from n=2,020 (March 2022), to n=3,253 (July 2023), marking an increase of approximately 62%1,2
Proportions and types of MCAs are consistent with epidemiological background.3–8 It is estimated that around 2–4% of all children born every year will have an MCA3–7
Enrolment of ~44 women at ≤GWk 30, whose last OCR dose occurred at any time from 6 months before the LMP until the end of the first trimester
Primary endpoint: Proportion of infants with B-cell levels below LLN at Week 6 of life
Enrolment of at least 20 women who delivered a term infant and made the decision to breastfeed whilst receiving OCR (inclusion from 2–24 weeks postpartum)
Co-primary endpoints: Proportion of infants with B-cell levels below LLN, measured 30 days after the mother’s first postpartum OCR infusion; estimated ADID over 60 days after the mother’s first postpartum OCR infusion
Please report any occurrence of pregnancy in women receiving OCR via our MedInfo portal here
The dash indicates that no cases were reported.
*Exposure classification is based on OCR t1⁄2=26 days (full elimination from the body is expected by approximately 4.5 months) and assuming no relevant placental transfer of IgG1 antibodies occurs prior to 12 weeks of gestation;13,14
†In utero exposure based on timing of last OCR dose relative to the LMP;
‡Percentages represent fractions of the total known outcomes of the respective exposure categories (not exposed in utero, exposed in utero, unknown exposure, total);
§Percentages represent fractions of the total live births for the respective exposure categories (not exposed in utero, exposed in utero, unknown exposure, total).
*Percentages represent fractions of total live births for the respective exposure category;
†The dash indicates that no cases were reported;
‡Percentages represent fractions of the total stillbirths/live births for the respective exposure category.
*The number of major congenital anomalies prospectively reported is 14, as one live birth reported two MCAs.
ADID, average daily oral infant dose; CIS, clinically isolated syndrome; EUROCAT, European Surveillance of Congenital Anomalies; GWk, gestation week; LLN, lower limit of normal; LMP, last menstrual period; MCA, major congenital anomalies; OCR, ocrelizumab.
M-XX-00015939 (Date of preparation: January 2024)