Jointly Sponsered by: CREDITS Physicians 0.25 AMA PRA Category 1 Credit(s) ™ Family Physicians 0.25 Elective credits Release Date: Apr. 29, 2012 Expiration Date: Apr. 29, 2013 Estimated time for completion 15.00 minutes There is no fee for this activity.
Jointly Sponsered by:
0.25 AMA PRA Category 1 Credit(s) ™
0.25 Elective credits
Apr. 29, 2012
Apr. 29, 2013
Estimated time for completion 15.00 minutes
There is no fee for this activity.
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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.Take Posttest
NEW ORLEANS — 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.
They reported that compared to unexposed pregnancies, fair to good quality prospective cohort studies reported that interferon-beta exposure was associated with lower mean birth weight, shorter mean birth length, and preterm birth, but not low birth weight, cesarean delivery, congenital anomaly, or spontaneous abortion.
While there were fewer studies of fair quality available for glatiramer acetate and natalizumab, neither drug was was associated with lower mean birth weight, congenital anomaly, preterm birth or spontaneous abortion.
However, they cautioned that the quality of all the studies ranged from poor to good and most studies were limited by small sample sizes. Also, few studies examined long-term developmental outcomes in children who were exposed in utero.
Lu said the jury is still out on recommendations for newer agents such as fingolimod (Gilenya). “There is no clear signal of harm with these newer drugs,” she said. “If women are exposed to these drugs, we don’t think we should recommend that they terminate their pregnancy, but they should try to come off the drug.”
Hellwig stressed the importance of counseling female MS patients about the possible consequences of MS drugs. In her study, 40% of the women experienced MS relapse while off natalizumab during pregnancy. “There does appear to be a protective effect of pregnancy on MS patients, but that protective effect is not complete,” she explained.
She pointed out that if severe MS activity occurs during the pregnancy, and the mother takes natalizumab during the last trimester, the babies require close watch after birth. “I would continually monitor the mother, and would closely follow the children for 2 years,” she said.
She said that additional safety data of natalizumab exposure during pregnancy are needed to exclude any major teratogenic or pro-abortive risks.
Hellwig disclosed commercial interests with Bayer Pharamceuticals, Schering AG, Biogen Idec, Merck Serono, Teva Neuroscience, Aventis Phramceuticals Corporation, Novartis, and Serono.
The German MS and pregnancy registry was partly supported by Bayer Healthcare, Biogen Idec Germany, Merck Serono, Teva Sanofi Aventis, and Novartis.
Primary source: American Academy of Neurology
Lu E, et al. “Disease-Modifying Drugs for Multiple Sclerosis in Pregnancy: A Systematic Review” AAN 2012;abstract P06.188.
Additional source: American Academy of Neurology
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Article source: http://www.medpagetoday.com/MeetingCoverage/AANMeeting/32411