Abstract Details

Title Pregnancy Outcomes in Patients Exposed to Intramuscular Interferon beta-1a (IM IFN?-1a)

Topic MS and Related Diseases

Presentation(s) S30 - (-)

Poster/Presentation
Number 006

Objective

Background Given the high prevalence of MS in women in their reproductive years, disease-modifying therapies are likely to be used by women of childbearing potential.

Design/Methods Worldwide pregnancy cases reported to Biogen Idec from May 1996 to 31 December 2012 will be reviewed for potential association between drug exposure and teratogenicity or maturation defects. Prospective cases involved IM IFN?-1a exposure during pregnancy, reported spontaneously or reported through clinical trials or registries, with the outcome unknown at the time of initial report.

Results From May 1996 to Jun 2012, there were over 1000 prospective pregnancies in IM IFN?-1a-exposed women from spontaneous reports only. Outcomes were known for about half of these cases with a birth defect rate of approximately 2%,including both major and minor congenital malformations. No pattern suggesting an unusual distribution of birth defects was observed. Birth defect rates in the general population are between 2.7% and 5.8%, depending on the methodology used for calculation (denominator being live birth cases or all outcomes). The reported rate of spontaneous loss was consistent with the expected rate of 15%-16% in the US general population. In the Avonex US pregnancy registry, birth defects reviewed according to MACDP standards were observed in 6.3% of 306 outcomes in 302 prospectively enrolled pregnant women; 5.6% if calculated with all outcomes in the denominator; the rate of spontaneous abortions was 10.5%.

Conclusions No pattern suggesting an unusual distribution of birth defects was observed among women with MS exposed to IM IFN?-1a during pregnancy. Reporting rates for spontaneous abortions were consistent with those in the general population.

Authors/Disclosures
Sylvie Tomczyk, MD (BiogenIdec) PRESENTER	No disclosure on file
Bjorn K. Sperling, MD	No disclosure on file
Wolfgang Walter Feneberg, MD (Marianne Strauss Klinik)	No disclosure on file

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