[S40.005] Subcutaneous Interferon beta-1a Treatment and Pregnancy Outcomes in Patients with Multiple Sclerosis

Magnhild Sandberg-Wollheim, Lund, Sweden, Enrica Alteri, Margaretha Stam Moraga, Gabrielle Kornmann, Geneva, Switzerland

OBJECTIVE: To determine pregnancy outcomes for women with multiple sclerosis (MS) receiving subcutaneous (sc) interferon (IFN) beta-1a. BACKGROUND: It is currently recommended that women of child-bearing potential take appropriate contraceptive measures while on IFN treatment to avoid becoming pregnant, and doctors usually suggest patients discontinue IFN therapy when trying to conceive. However, the risks related to IFN exposure during pregnancy remain unclear. A previous review of data from eight published clinical trials suggested that 91% of pregnancies exposed to sc or intramuscular IFN beta-1a resulted in healthy, full-term infants (Sandberg-Wollheim M, et al. Neurology 2005;65:8026). DESIGN/METHODS: The Merck Serono Global Safety Database was used to identify pregnancies in women exposed to sc IFN beta-1a reported between 01 February 1998 and 31 December 2008. Prospective and retrospective data of pregnancy exposure and outcome were acquired and analyzed. RESULTS: In total, 839 pregnancy reports were retrieved. Of these, 546 pregnancies had a documented outcome and 293 pregnancies had no reported outcome. To avoid reporting bias, only prospective pregnancy exposure data (where data were acquired prior to the knowledge of the pregnancy outcome; n=322) were included in this analysis. The majority of these pregnancies exposed to sc IFN beta-1a were associated with normal live births (251/322, 78.0%). The frequency of spontaneous abortion (32/322, 9.9%) was similar to that in the general population. The frequency of live births with a major congenital anomaly was 0.3% (1/322), also in line with population data. CONCLUSIONS/RELEVANCE: These data should be taken into consideration by patients and physicians when confronted with a decision to terminate pregnancy following inadvertent exposure to sc IFN beta-1a during early stages of pregnancy. Supported by: Sponsored by Merck Serono S.A. Geneva, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany.
Category - MS and Related Diseases - Clinical Science

Wednesday, April 14, 2010 5:15 PM

Scientific Sessions: Multiple Sclerosis: Epidemiology (4:15 PM-5:30 PM)