Study Design of a Multinational Gilenya™ (Fingolimod) Pregnancy Exposure Registry

Background: Gilenya™ (fingolimod) is a once-daily, oral therapy approved for relapsing forms of multiple sclerosis (MS). The safety profile of fingolimod has been well-characterized in a large clinical trial program in MS and postmarketing surveillance, however, the safety profile of fingolimod in pregnancy and fetal outcomes has not yet been well established.

Objectives: To collect and evaluate the safety data on maternal, fetal, and infant outcomes associated with exposure to fingolimod, immediately before and during pregnancy. 

Methods: The Gilenya Pregnancy Registry is a multinational, observational, prospective registry study with a minimum duration of 6 years, and plans to include up to 500 pregnant women exposed to at least 1 dose of fingolimod before (no more than 8 weeks before last menstruation) or anytime during pregnancy. Pregnancy and maternal outcome measures, which will be collected during and at the end of pregnancy, include the frequency of major and minor congenital malformations and any other pregnancy or fetal outcomes that may arise. Infants will be followed for 1 year postpartum. 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: The Gilenya Pregnancy Registry was launched and activated worldwide in February 2012.  7 patients have been enrolled as of August 2012. The most recent data on maternal/fetal exposure to fingolimod and associated outcomes reported in the registry will be presented.

Conclusions: The Gilenya Pregnancy Registry is designed to investigate and generate a reliable safety profile regarding pregnancy outcomes and fetal effects resulting from fingolimod exposure. Study findings will be useful to physicians treating and counseling pregnant women with MS who have been or may be exposed to fingolimod during pregnancy.