Miracle Pregnancy

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.

To Receive CME Credit

In order to receive your certificate of participation, you should read the information about this activity, including the disclosure statements, review the entire activity, correctly answer all the questions in the post-test, and complete the evaluation form. You may then follow the directions to print your certificate of participation.

Program Overview

Among the many issues clinicians face today, staying current with advances in medicine is becoming a major challenge. Teaching Brief® articles will allow clinicians to stay up-to-date and assimilate new information into their daily practice. The content of these Teaching Brief® articles has been validated through an independent expert peer review process.

Learning Objectives

Upon successful completion of this educational program, the reader should be able to:

1. Discuss the results of this study

2. Review the relevance and significance of the study in the broader context of clinical care

Disclosures

Robert Jasmer, MD, and Ed Susman, have disclosed that they have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity.

The staff of the Perelman School of Medicine at the University of Pennsylvania and the staff of MedPage Today have disclosed that they have no relevant financial relationships with commercial interests related directly or indirectly to this educational activity.

Accreditation

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Perelman School of Medicine at the University of Pennsylvania and MedPage Today. The Perelman School of Medicine at the University of Pennsylvania is accredited by the ACCME to provide continuing medical education for physicians.

Designation of Credit

The Perelman School Medicine at the University of Pennsylvania designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Credit for Family Physicians

MedPage Today “News-Based CME” has been reviewed and is acceptable for up to 2098 Elective credits by the American Academy of Family Physicians. AAFP accreditation begins January 1, 2012. Term of approval is for one year from this date. Each article is approved for 0.25 Elective credits. Credit may be claimed for one year from the date of each article.

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

Source reference:
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

Source reference:
Hellwig K, et al. “Natalizumab and Pregnancy – Results from the German MS and Pregnancy Registry” AAN 2012;abstract P06.187.

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