Final Results from the AVONEX(R) (Intramuscular Interferon Beta-1a) Pregnancy Exposure Registry (P06.191)

Abstract

Objective: To prospectively record and analyze pregnancy outcomes in women with multiple sclerosis (MS) who were exposed to intramuscular interferon beta-1a (IM IFNβ-1a) within approximately 1 week of conception or during the first trimester of pregnancy. Background The onset of MS typically occurs between the ages of 20 and 40 years, affecting women during their reproductive years. Many MS patients are treated with disease-modifying therapy (DMT), but published information on the effects of DMT on pregnancy is limited. In addition to routine surveillance of spontaneous reports, a formal pregnancy registry was created in January 2003 to prospectively evaluate the effect of IM IFNβ-1a on pregnancy outcomes. Design/Methods: The AVONEX Pregnancy Exposure Registry is an observational prospective study conducted in the United States. Information on IM IFNβ-1a use during pregnancy, potential confounding factors, and pregnancy outcomes is collected at months 4–5 of pregnancy and weeks 8–12 post-delivery in order to detect any evidence of teratogenic effects or increased risk of spontaneous loss in pregnancies exposed to IM IFNβ-1a. Birth defect cases include targeted follow-up and adjudication by a birth defect evaluator. An advisory committee of external experts monitors and reviews all pregnancy outcome data. Results: As of May 16, 2011, 307 patients had been enrolled in the registry, and recruitment was completed; 298 cases with outcomes were available, including 261 live births and 30 spontaneous abortions. Twenty-seven outcomes resulted in defects. Final results, including the advisory committee9s interpretation of the data, will be presented. Conclusions: The most recent advisory committee review took place in October 2009, when approximately 75% of the pregnancy outcomes were available. At that time it was concluded that the registry data did not suggest any effect of IM IFNβ-1a exposure on pregnancy outcomes. Now that the registry is fully accrued, we will present results from the complete data set. Supported by: Biogen Idec Inc. Disclosure: Dr. Richman has received personal compensation for activities with Biogen Idec as employees.Dr. Richman holds stock and/or options in Biogen Idec, which sponsored research in which Dr. Richman was involved as an investigator. Ms. Wallace has received personal compensation for activities with Biogen Idec as an employee. Dr. Liu has received personal compensation for activities with Biogen Idec as an employee.Dr. Liu holds stock and/or stock options in Biogen Idec Inc. Dr. Sperling has received personal compensation for activities with Biogen Idec as an employee. Dr. Sperling holds stock and/or stock options in Biogen Idec.