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Abstract Details

Multinational GilenyaTM (Fingolimod) Pregnancy Exposure Registry: Preliminary Results
MS and Related Diseases
P02 - (-)
134
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.
Authors/Disclosures

PRESENTER 		No disclosure on file
Helmut Butzkueven, MD, MBBS Dr. Butzkueven has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Oxford Health Policy Forum. The institution of Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. The institution of Dr. Butzkueven has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. The institution of Dr. Butzkueven has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for MSBase . The institution of Dr. Butzkueven has received research support from NHMRC. The institution of Dr. Butzkueven has received research support from Biogen. The institution of Dr. Butzkueven has received research support from Roche. The institution of Dr. Butzkueven has received research support from Novartis.
Jeffrey A. Cohen, MD (Cleveland Clinic) Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Cohen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viatris. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSI. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celltrion.
No disclosure on file
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No disclosure on file
Dina Anand No disclosure on file
No disclosure on file
No disclosure on file
Kerstin Hellwig (St. Josef Hospital Bochum) Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mylan . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche . The institution of Kerstin Hellwig has received research support from Roche . The institution of Kerstin Hellwig has received research support from Merck . The institution of Kerstin Hellwig has received research support from Biogen. The institution of Kerstin Hellwig has received research support from Genzyme . The institution of Kerstin Hellwig has received research support from Novartis . The institution of Kerstin Hellwig has received research support from BMS .