Tysabri Seems OK for Expectant Mothers with MS

By Ed Susman, Contributing Writer, MedPage Today

Published: April 29, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

Accidental fetal exposure to natalizumab did not appear associated with shorter mean birth length, lower mean birth weight, or lower mean gestational age in pregnant multiple sclerosis patients, according to small studies presented here.

Based on data from an MS and pregnancy registry in Germany, seven babies born to MS patients were exposed to natalizumab (Tysabri) during the third trimester and two were found to have profound anemia at birth, but both recovered and all the infants in the group are now healthy, said Kerstin Hellwig, MD, from St. Josef Hospital/Ruhr University in Bochum, at the annual meeting of the American Academy of Neurology.

Women with MS are often advised to discontinue disease-modifying drugs prior to conceiving — Hellwig noted that current recommendations call for suspension of natalizumab therapy 3 months prior to a planned pregnancy — but accidental exposure still occurs.

In the national registry, Hellwig said 62 pregnancies were recorded in which exposure to natalizumab occurred at some time point during gestation. Of those babies, 48 babies were born healthy. One boy was born with an extra digit that successfully amputated at age 1. There were 11 spontaneous miscarriages occurred, there was one tubal pregnancy, and one women electively terminated the pregnancy.

“From our study it appears that accidental exposure to natalizumab in the first trimester does not appear to cause major risk to the children,” she said. “There might be some minor risks but we cannot observe them at the present because we have small numbers of patients.”

In a second study, Ellen Lu, a PhD candidate at the University of British Columbia in Vancouver, and colleagues conducted a literature review through August 2011 and found 15 studies that identified 761 interferon-beta, 97 glatiramer acetate (Copaxone), and 35 natalizumab exposed pregnancies.

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