Abstract Details

Title Evaluation of Pregnancy Outcomes from the TYSABRI® (Natalizumab) Pregnancy Exposure Registry

Topic MS and Related Diseases

Presentation(s) P02 - (-)

Poster/Presentation
Number 127

Objective

Background BACKGROUND: Women of childbearing potential with multiple sclerosis (MS) are likely to be exposed to disease-modifying therapies around the time of conception and pregnancy. Biogen Idec and Elan Pharmaceuticals implemented the TYSABRI® (natalizumab) Pregnancy Exposure Registry (TPER) to prospectively assess whether natalizumab exposure has any effect on pregnancy outcomes. Patients who received natalizumab for the treatment of Crohn's disease (CD) are included.

Design/Methods DESIGN/METHODS: TPER is a global, observational, exposure-registration, follow-up study targeting a minimum of 300 prospectively-enrolled pregnant women with MS or CD exposed to natalizumab within 90 days prior to the first day of the LMP or during pregnancy. Information on natalizumab exposure and pregnancy outcomes is collected. Enrollment for the study has completed and registry follow-up is ongoing.

Results RESULTS: As of 23 May 2012, 375 patients (368 with MS; 7 with CD) were registered prospectively in TPER. There were 362 known pregnancy outcomes available, 11 pregnancies were ongoing and 10 were lost to follow-up. There were 314 live births, including 8 twin pregnancies, 13 elective terminations, 34 spontaneous abortions, and 1 stillbirth. Major and/or minor birth defects were observed in 28 pregnancy outcomes in 26 women.

Conclusions CONCLUSIONS: Present data do not suggest any effect of natalizumab exposure on pregnancy outcomes. The rate of spontaneous pregnancy losses is consistent with background rates in the US general population. Final registry data will be presented. Data from TPER provide an important source of information for patients regarding exposure to natalizumab during pregnancy. Additional data are required before definite conclusions can be made about the effect of natalizumab exposure on pregnancy outcomes.

Authors/Disclosures
Lynda M. Cristiano, MD PRESENTER	No disclosure on file
	No disclosure on file
Carmen Bozic, MD (Biogen Idec)	No disclosure on file
	No disclosure on file
Gary Bloomgren, MD, MBA (Biogen Idec)	No disclosure on file

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