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Case Report/Case Series |

Natalizumab Use During the Third Trimester of Pregnancy

Aiden Haghikia, MD1; Annette Langer-Gould, MD, PhD2; Georg Rellensmann, MD3; Henriette Schneider, MD4; Tobias Tenenbaum, MD4; Birte Elias-Hamp, MD5; Sylvia Menck, MD6; Julian Zimmermann, MD7; Sandra Herbstritt, PharmD8; Martin Marziniak, MD9; Tania Kümpfel, MD10; Ingrid Meinl, MD10; Tatiana Plavina, PhD11; Ralf Gold, MD1; Kerstin Hellwig, MD1,2
[+] Author Affiliations
1Department of Neurology, St Josef-Hospital, Ruhr University Bochum, Bochum, Germany
2Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena
3Department of General Pediatrics, University Children’s Hospital Münster, Münster, Germany
4University Children’s Hospital Mannheim, Heidelberg University, Heidelberg, Germany
5Neurologic Practice Hamburg, Hamburg, Germany
6Neurologic Practice Barsinghausen, Barsinghausen, Germany
7Department of Neurology, University of Bonn, Bonn, Germany
8Faculty of Pharmacy, University of Dusseldorf, Dusseldorf, Germany
9Department of Neurology, kbo-Isar-Amper-Klinikum München-Ost, Munich, Germany
10Institute for Clinical Neuroimmunology, Ludwig-Maximilians-University, Munich, Germany
11Biogen Idec, Cambridge, Massachusetts
JAMA Neurol. 2014;71(7):891-895. doi:10.1001/jamaneurol.2014.209.
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Importance  Natalizumab reduces multiple sclerosis relapses very effectively; however, severe disease activity may return once natalizumab treatment is withdrawn, as recommended during pregnancy. Sometimes restarting natalizumab treatment may be the best option for the mother, but the consequences for the infant are unknown. Except for a few single case reports, to our knowledge, comprehensive data about third-trimester natalizumab exposure are scant.

Observations  In a case series of 12 women with 13 pregnancies and highly active multiple sclerosis who were treated with natalizumab during their third trimester of pregnancy, we assessed the clinical and laboratory effects on the newborns. We observed mild to moderate hematologic alterations in 10 of 13 infants including thrombocytopenia and anemia. In a subsample of 5 mother-child pairs, we analyzed natalizumab levels in the umbilical cord blood. Natalizumab was detectable in all 5 newborns.

Conclusion and Relevance  Natalizumab can be a therapeutic option in patients with highly active multiple sclerosis during pregnancy. We recommend that a pediatrician be available at the time of delivery to evaluate for potential complications of anemia and thrombocytopenia in newborns exposed to natalizumab during the third trimester.

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Natalizumab Concentrations in Mothers and Newborns After Birth

Natalizumab concentrations in newborns and mothers after birth (B) dependent on the number of natalizumab infusions (N) during pregnancy and interval from last infusion to delivery.

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