Center Researchers Find Adalimumab Exposure in Pregnancy Does Not Increase Birth Defects Risk

Adalimumab (sold under the trade name Humira®) is a medication used to treat a number of autoimmune diseases, including rheumatoid arthritis and Crohn’s Disease. But what effects might it have if it is taken during pregnancy? Our new study, which was published today in the journal Public Library of Science (PLOS) One, examined this very question.

What did we do? As part of our MotherToBaby Pregnancy Studies, we recruited 602 pregnant women across the United States and Canada between 2004-2016. This included women who had or had not taken adalimumab for their autoimmune disease, as well as generally healthy pregnant women for comparison. Women were followed until they delivered their babies, and their babies were followed up to 1 year of age. We collected information by interviewing moms, examining medical records, and conducting a specialized exam with the babies. Funding for the study was provided by AbbVie.

What did we find? We found that the use of adalimumab in pregnancy is not associated with an increased risk for adverse outcomes, such as major structural birth defects, spontaneous abortion, and preterm delivery. We also found that regardless of whether they took adalimumab, pregnant women with rheumatoid arthritis or Crohn’s Disease were at an increased risk of delivering their baby pre-term (before 37 weeks of pregnancy).

So what’s the take-away? The lead investigator on this study and our Center co-director Dr. Tina Chambers, PhD, MPH, said it best: “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. 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.”

She added that, “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.”

To learn more about our ongoing MotherToBaby Pregnancy Studies, visit, call (877) 311-8972, email

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