Abstract Details

Title Pregnancy Outcomes from the Teriflunomide Clinical Development Program: Retrospective Analysis of the Teriflunomide Clinical Trial Database

Topic MS and Related Diseases

Presentation(s) S30 - (-)

Poster/Presentation
Number 005

Objective

Background Teriflunomide is a once-daily, oral disease-modifying therapy recently approved in the US for relapsing forms of multiple sclerosis. Animal studies of teriflunomide have demonstrated embryotoxicity and teratogenicity. Despite the requirement that women participating in teriflunomide clinical studies use effective contraception, a number of pregnancies have been reported across the program.

Design/Methods Pregnancies in female study patients were reported in the teriflunomide pharmacovigilance database (data cut-off: August 21, 2012). Information on pregnancy outcomes was collected from patient files using a Drug Exposure Via Parent form.

Results Seventy one pregnancies were reported in females across nine Phase II/III clinical studies. Upon learning of their pregnancies, patients were instructed to discontinue their study treatment and undergo an accelerated elimination procedure (cholestyramine or activated charcoal). Outcomes of the pregnancies were: induced abortion, n=34; spontaneous abortion, n=15; live births, n=17; ongoing pregnancy, n=5. Forty four of the 71 pregnancies were reported in patients exposed to teriflunomide; the remaining pregnancies occurred in patients treated with placebo, interferon beta, or blinded therapy. In the 17 live births, including 12 exposed to teriflunomide, no structural defects or functional deficits have been reported to date. In newborns for whom data are available (n=12), birth weights ranged from 2780g to 4150g, and the duration of fetal exposure was up to 11 weeks. The majority of patients (89%) reported missing their contraceptive method, while 11% pro-actively chose to become pregnant.

Conclusions There continues to be no signal for teratogenicity in newborns with prenatal teriflunomide exposure following accelerated elimination. More prospective data are needed with respect to pregnancy outcomes. A pregnancy registry is planned to collect all related data.

Authors/Disclosures
Lily J. Henson, MD, MMM, FAAN (Piedmont Augusta Hub) PRESENTER	Dr. Henson has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for various law firms. An immediate family member of Dr. Henson has received publishing royalties from a publication relating to health care.
Olaf Stuve, MD, PhD, FAAN (UT Southwestern Medical Center)	Dr. Stuve has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Stuve has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Stuve has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Therapeutic Advances in Neurological Diseases. Dr. Stuve has received research support from US Department of Veterans Affairs. Dr. Stuve has received research support from National Multiple Sclerosis Society (US). Dr. Stuve has received research support from Merck KGaA.
Michaela Starck, MD (Schering)	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

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