DX50
Ocrelizumab Pregnancy Registry to Assess Maternal, Fetal and Infant Outcomes in Women with Multiple Sclerosis Exposed to Ocrelizumab during Pregnancy
Ocrelizumab (OCR) is a recombinant, humanized, monoclonal immunoglobulin G1 antibody that selectively targets CD20+ B cells. Immunoglobulins are known to cross the placental barrier. The safety profile of OCR has been characterized in multiple clinical trials. While pregnancy outcomes have been reported, the safety profile of OCR in pregnancy and fetal outcomes has yet to be completely established. Women of childbearing age should use contraception while receiving OCR and for 6 months after the last infusion of OCR.
Objectives:
To assess maternal, fetal and infant outcomes in women with multiple sclerosis (MS) exposed to OCR during the 6 months prior to their last menstrual period or any time during pregnancy.
Methods:
The Ocrelizumab Pregnancy Registry is a multicenter, prospective, observational study conducted in the United States and Germany. Data will be collected through questionnaires completed by patients and their healthcare providers. The design of this registry is consistent with relevant FDA guidelines and recommendations. Frequencies of adverse pregnancy outcomes (including spontaneous/elective abortions, stillbirths and preterm births) and adverse infant outcomes (including congenital malformations, and postnatal growth and development) through at least the first year of life will be estimated and compared with data from unexposed control populations, including the Metropolitan Atlanta Congenital Defects Program (MACDP), the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) and the German MS Pregnancy Registry.
Results:
The study is planned to start in early 2018 and will last approximately 10 years. Follow-up will be at approximately 14, 21 and 34 weeks’ gestation, 4 weeks after delivery date and up to 52 weeks after birth.
Conclusions:
This study will provide insights on the safety profile of ocrelizumab during pregnancy in a real-world setting and will support discussions with pregnant women with MS who may have been exposed to ocrelizumab before or during pregnancy.