OBJECTIVE: To prospectively collect and evaluate the safety data on maternal, fetal, and infant outcomes associated with exposure to fingolimod, immediately before and during pregnancy.
BACKGROUND: Fingolimod 0.5 mg once daily, the first sphingosine 1-phosphate receptor modulator, approved for the treatment of relapsing multiple sclerosis (MS) has a well characterized safety profile based on a large clinical trial program in MS and post-marketing experience. However, current data on pregnancy outcomes and effects on the fetus are limited.
DESIGN/METHODS: Gilenya Pregnancy Registry is an at least 6-year, multinational, observational registry study. Information on pregnant women exposed to fingolimod is provided to the registry prospectively through healthcare providers. Retrospective cases can be enrolled but will be analyzed separately. Pregnancy and maternal outcomes will be collected during and at the end of pregnancy and infants will be followed up to first year of their life. Reference data for comparison will be retrieved from US Centers for Disease Control, European Surveillance of Congenital Anomalies, published medical literature and other MS registries.
RESULTS: As of August 2012, 7 patients have been enrolled in the registry. 6 patients were exposed to fingolimod during their 1st trimester and 2 of them up to 2nd trimester. Information is pending for the remaining patient. 2 of the 7 cases were enrolled prospectively. Known outcome are so far 1 healthy baby and 1 elective termination. The most recent data on maternal exposure to fingolimod and pregnancy outcomes from the registry will be presented.
CONCLUSIONS: Reliable safety data from the registry will be useful for treating and counseling women with MS who have been or may be exposed to fingolimod during pregnancy.
