Q: If I take a biologic, will it be more difficult to become pregnant?
A: Information is very limited, but to date neither preclinical data nor clinical data indicate that becoming pregnant is more difficult.
Q. If I do become pregnant while on a biologic drug, do I have a chance of having a baby with a birth defect?
A. One of the principles of teratology is that known teratogens tend to cause specific patterns of malformations. To date with the limited information available, neither animal nor human data suggest that the risk for a specific pattern of defects is increased over baseline if you take a biologic agent while pregnant. While preliminary results from the OTIS project have noted that more malformations occurred in the offspring of women taking etanercept, the defects were varied and isolated.
Q. If I do become pregnant while taking this drug, will my child's immune system be compromised?
A. There are limited human data available for rituximab. To date, the results of the OTIS study do not indicate an increase in opportunistic infections, hospitalizations, or malignancies in the infants of women who have taken etanercept or adalimumab.
Q. If I do become pregnant while taking a biologic agent, do I have to discontinue the drug or can I safely continue to take the drug throughout pregnancy?
A. We really don't know the answer. In the OTIS project, approximately half of women on etanercept or adalimumab remain on the medication into the second or third trimester.
Disclosures: Dr. Chambers has received research grants from Sandoz, Kali Labs, Apotex, Barr Labs, Teva Pharmaceuticals, Amgen, Bristol Myers Squibb, Abbott Laboratories, Sanofi-Aventis Pharmaceutical, and Sanofi-Pasteur.
BY CHRISTINA CHAMBERS, Ph.D.