In:
Multiple Sclerosis Journal, SAGE Publications, Vol. 21, No. 2 ( 2015-02), p. 198-205
Abstract:
Safety data on first-trimester natalizumab exposure are scarce, as natalizumab is usually withdrawn three months before pregnancy. Objective: The objective of this paper is to investigate the fetal safety of exposure to natalizumab (Tysabri ® ) during the first trimester of pregnancy using disease-matched (DM) and healthy control (HC) comparison groups. Methods: A total of 101 German women with RRMS exposed to natalizumab during the first trimester of pregnancy were identified. Birth outcomes in the exposed group were compared to a DM group ( N = 78) with or without exposure to other disease-modifying drugs, and an HC group ( N = 97). Results: A total of 77, 69 and 92 live births occurred in the Exposed, DM and HC groups, respectively. The rates of major malformations ( p = 0.67), low birth weight ( 〈 2500 grams) ( p = 1.0) and premature birth ( p = 0.37) did not differ among groups. Higher miscarriage rates ( p = 0.002) and lower birth weights ( p = 0.001) occurred among the Exposed and DM groups, as compared to the HC; however, there was no significant difference between the Exposed and DM groups. Conclusion: Exposure to natalizumab in early pregnancy does not appear to increase the risk of adverse pregnancy outcomes in comparison to a DM group not exposed to natalizumab.
Type of Medium:
Online Resource
ISSN:
1352-4585
,
1477-0970
DOI:
10.1177/1352458514546790
Language:
English
Publisher:
SAGE Publications
Publication Date:
2015
detail.hit.zdb_id:
2008225-3
