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• W2313302533 abstract "Objective: To present safety data of natalizumab exposure during pregnancy. Secondly, to assess the natalizumab serum concentration in the newborns to evaluate the transplacentar transport of natatlizumab. Thirdly, to assess relapses during pregnancy in exposed women who stopped the treatment after becoming aware of pregnancy. Background Natalizumab is recommended to be withdrawn 3 months prior to pregnancy. Few data are available about exposure during pregnancy. Reports of rebound of disease activity have been published, if patients stopped natalizumab. Design/Methods: We enrolled pregnant women with MS nationwide being exposed at some timepoint of pregnancy to natalizumab. Results: We identified 74 pregnancies with natalizumab exposure during pregnancy; most of them stopped treatment in the first trimester. 11 of these pregnancies (14,8%) resulted in early spontaneous abortions. One was a tubal pregnancy; one terminated electively. One resulted in a miscarriage in the 15th gestational week; the fetus suffered form a complex cardiac malformation. All newborns, except one, who was born with hexadactyly, were healthy. Of 51 terminated pregnancies 22 women had (4/12/9/trimester) relapses during pregnancy; and 4 were again with natalizumab during pregnancy. 3 of these 4 treated newborns showed haematological noticeable problems after delivery, resolving during the first weeks. Natalizumab could be detected in one of the newborns analysing the concentration in the umbilical cord, indicating that there is a transport to the fetus. The finalized dataset will be presented at the time of the meeting. Conclusions: If treatment with natalizumab is necessary during the second or third trimester, the newborns should be monitored closely after birth. Additional safety data of natalizumab exposure during pregnancy are needed to exclude any major teratogenic and/or pro-abortive risk. Supported by: The German MS and pregnancy registry was partly supported by Bayer Healthcare, Biogen Idec Germany, Merck Serono, Teva Sanofi Aventis and Novartis. Disclosure: Dr. Hellwig has received personal compensation for activities with Bayer Phramceuticals Corporation, Schering AG, Biogen Idec, Merck Serono, Teva Neuroscience, Aventis Phramceuticals Corporation and Novartis as a speaker.Dr. Hellwig has received research support from Bayer Phramceuticals Corporation, Schering AG, Biogen Idec, Serono, Novartis and Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc. Dr. Haghikia has nothing to disclose. Dr. Gold has received personal compensation for activities with Bayer Pharmaceuticals Corporation, Biogen Idec, Merck Serono, Teva Neuroscience. Dr. Gold has received personal compensation in an editorial capacity for Therapeutic Advances in Neurological Disorders. Dr. Gold has received (royalty or license fee or contractual rights) payments from Biogen Idec. Dr. Gold has received research support from Bayer Pharmaceuticals Corporation, Biogen Idec, Merck Serono, Novartis and Teva Neuroscience." @default.
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• W2313302533 date "2012-04-22" @default.
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• W2313302533 title "Natalizumab and Pregnancy - Results from the German MS and Pregnancy Registry (P06.187)" @default.
• W2313302533 doi "https://doi.org/10.1212/wnl.78.1_meetingabstracts.p06.187" @default.
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