Study Suggests Adalimumab Exposure in Pregnancy Does Not Increase Birth Defects Risk

602 Pregnancies Examined by the Non-Profit Organization of Teratology Information Specialists

A new study conducted by birth defects experts from the Organization of Teratology Information Specialists (OTIS) suggests adalimumab use in pregnancy was not associated with an increased risk for adverse outcomes examined, such as major structural birth defects, spontaneous abortion and preterm delivery. The findingswere published today in the Public Library of Science (PLOS) One Journal.

The prospective research study conducted by OTIS examined 602 pregnancies that occurred between 2004 – 2016 in women across the U.S. and Canada. Researchers enrolled pregnant women into the observational cohort study who had or had not taken adalimumab for their autoimmune disease, as well as generally healthy pregnant women for comparison. OTIS is the scientific non-profit society that provides the no-cost MotherToBaby information service and enrolls women through the MotherToBaby Pregnancy Studies Research Center at the University of California San Diego. Financial support for the adalimumab study was provided by AbbVie.

“Many women hoping to start a family rely on adalimumab to control symptoms related to crippling autoimmune diseases such as rheumatoid arthritis or Crohn’s Disease,” said lead study author Christina Chambers, PhD, MPH, OTIS/MotherToBaby president and professor of pediatrics at the University of California, San Diego. “The fact that this study showed no increased risk in adverse birth outcomes with the use of adalimumab in pregnancy is important since not a lot of research was previously available on this particular medication.”

The study also found that regardless of whether they took adalimumab or not, pregnant women with rheumatoid arthritis or Crohn’s Disease were at an increased risk of preterm birth (delivery before 37 weeks of pregnancy).

“Studies on medication use in general are lacking when it comes to understanding their effects on pregnancy, making it difficult for pregnant women and their healthcare providers to make informed decisions,” said Dr. Chambers. “We are proud to add valuable information to the literature and encourage more pregnant women to consider volunteering for critical observational studies.”

For more information on all of the current MotherToBaby Pregnancy Studies, please visit https://mothertobaby.org/pregnancy-studies/.

More about OTIS and MotherToBaby

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The Organization of Teratology Information Specialists (OTIS) is a professional scientific society made up of individuals engaged in assessing and evaluating risks to pregnancy and breastfeeding from environmental exposures. Members include, but are not limited to, specialists in the fields of: obstetrics and gynecology, pediatrics, genetics, dysmorphology, perinatal epidemiology, teratology, behavioral teratology, pharmacy, genetic counseling, nursing, midwifery, maternal and child health, public health, and includes experts that provide MotherToBaby services and researchers that conduct MotherToBaby Pregnancy Studies. MotherToBaby is a suggested resource by many federal agencies including the Centers for Disease Control and Prevention (CDC). To learn more about ongoing MotherToBaby Pregnancy Studies, call (877) 311-8972, email [email protected] or visit http://www.MotherToBaby.org.

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Media Contact: Nicole Chavez, 619-368-3259, [email protected].

OTIS provides the MotherToBaby service

The fact that this study showed no increased risk in adverse birth outcomes with the use of adalimumab in pregnancy is important since not a lot of research was previously available on this particular medication.