[P04.186] Pregnancy Outcomes from the AVONEX (Interferon beta-1a) Pregnancy Exposure Registry

Pamela Foulds, Wellesley, MA, Sandra R. Richman, Gabrielle Glick, Timna Onigman, Cambridge, MA

OBJECTIVE: To prospectively analyze pregnancy outcomes in women with MS who were exposed to intramuscular (IM) interferon beta-1a (IFNb -1a) during the first trimester of pregnancy or within one week of conception. BACKGROUND: Multiple sclerosis (MS) often affects women during their reproductive years, and disease-modifying therapies (DMTs) are likely to be widely used by women of childbearing potential. However, published information on the effects of DMTs on pregnancy outcomes in the literature is limited. DESIGN/METHODS: The AVONEX Pregnancy Exposure Registry is an observational, exposure-registration and follow-up study of pregnant women with MS who were exposed to IM IFNb -1a within approximately 1 week of conception or during the first trimester of pregnancy. Information on IM IFNb -1a exposure, potential confounding factors (eg, medical history, other medications, smoking), and pregnancy outcomes was collected at 4- 5 months of pregnancy and 8- 12 weeks after delivery. If a birth defect was reported, targeted follow-up was conducted. RESULTS: A total of 262 pregnancies have been enrolled as of October 2, 2009. Of these, there have been 193 live births, 28 spontaneous abortions, 4 induced abortions, 1 still birth, 30 pending outcome, and 6 lost to follow-up. Of the 193 live births, 15 have been associated with defects. The rate of major/serious birth defects was not increased with IM IFNb -1a exposure. No malformations or groups of malformations were over-represented compared with background rates in the general population. CONCLUSIONS/RELEVANCE: The rate of major/serious birth defects was not increased with IM IFNb -1a exposure and no malformations or groups of malformations were over-represented in this prospective registry when compared with the general population. Available information should be reassuring for cases where exposure to IM IFNb -1a has occurred during pregnancy. Supported by: Biogen Idec, Inc.
Category - MS and Related Diseases - Clinical Science

Wednesday, April 14, 2010 3:00 PM

Poster Session IV: Multiple Sclerosis and Related Diseases: Clinical Research and Pathology (3:00 PM-7:30 PM)