Multinational Gilenya™ (Fingolimod) Pregnancy Exposure Registry: Preliminary Results (P02.134)

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. Supported by: Novartis Pharma AG, Basel, Switzerland. Disclosure: Dr. Geissbuhler has received personal compensation for activities with Novartis as an employee. Dr. Butzkueven has received personal compensation for activities with Biogen Idec, Novartis for scientific advisory boards, from Novartis, CSL (Australia) as a speaker, conference travel support from Biogen Idec, Novartis. Dr. Butzkueven has received research support from Merck Serono, Biogen Idec, Novartis. Dr. Hernandez-Diaz provides consultations to Novartis and AstraZeneca Pharmaceuticals......Dr. Hernandez-Diaz recieved unrestricted training grants from Pfizer Inc and Novartis for pharmacoepidemiology program at Harvard Dr. Koren has received personal compensation for activities with Novartis. Dr. Koren has received personal compensation in an editorial capacity for Therapeutic Drug Monitoring. Dr. MacDonald has received personal compensation for activities with Pfizer, Novartis, Kaiser Permanante, Takeda, Recordati, Servier, Menarini, NiCox and AstraZeneca Pharmaceuticals. as a consultant and/or speaker. Dr. Tilson has received personal compensation for activities with global pregnancy and disease registries and Federal Drug Administration, Health Resources and Services Administration and the WHO Collaborating Centres on Drug Safety. Dr. Starzyk has received personal compensation for activities with Novartis. Dr. Plana has received personal compensation for activities with Novartis Pharmaceuticals S.A. as an employee. Dr. Cremer has received personal compensation for activities with Novartis. Dr. Von Rosenstiel has received personal compensation for activities with Novartis. Dr. Anand has received personal compensation for activities with Novartis as an employee. Dr. Schlosshauer has received personal compensation for activities with Novartis Pharma AG as an employee. Dr. Yuanyuan has received personal compensation for activities with Novartis. Dr. Hellwig has received personal compensation for activities with Bayer, Biogen Idec, Merck Serono, Teva, and Novartis. Dr. Hellwig has received research support from Bayer, Biogen Idec, Merck Serono, Novartis and Teva/Sanofi Aventis.