Women with chronic autoimmune diseases who take immunosuppressive medications during their first trimester of pregnancy are not putting their babies at significantly increased risk of adverse outcomes, according to a Vanderbilt study released online by the journal Arthritis and Rheumatism.

The paper is one of the first to describe risks for medications used to treat autoimmune diseases when taken during pregnancy, according to first author William Cooper, M.D., MPH, Cornelius Vanderbilt Professor of Pediatrics and professor of Health Policy at Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville, Tenn.

"This study is important because these conditions affect nearly 4.5 million persons in the U.S., including many women of childbearing age," Cooper said. "Currently, there are almost no data to guide women who are pregnant, or planning to become pregnant, who may need to continue their medications during pregnancy."

Study authors used health plan data from Tennessee Medicaid, Kaiser Permanente Northern California and Southern California, linked with vital records and medical records. The three geographically diverse health plans collectively provide coverage for more than 8 million persons each year.

The cohort included 608 infants, including 437 with exposure during pregnancy and 171 whose mothers filled prescriptions for immunosuppressives before, but not during, pregnancy.

Women with rheumatoid and psoriatic arthritis, ankylosing spondylitis, lupus, scleroderma, and inflammatory bowel disease who filled prescriptions for immunosuppressive treatments during pregnancy were included in the study.

The drugs studied included hydroxychloroquine, tumor necrosis factor (TNF) inhibitors and other immunosuppressives such as sulfasalazine and azathioprine.

When compared with the women who had medication treatment before, but not during, pregnancy the risk ratios for adverse fetal outcomes associated with immunosuppressive use during pregnancy were not statistically significant, the authors reported.

Cooper said some of the medications in the study are relatively new and therefore haven't been extensively used in pregnancy. As use continues to expand, follow-up studies will be important to ensure that new safety signals aren't detected.

"One of the things we find in studying drug exposures in pregnancy is that, because up to 50 percent of pregnancies are unplanned, women may be taking a medication and become pregnant while still taking a potentially harmful drug," Cooper said. "Therefore, it's very important for women who have conditions that require medical treatments to talk with their providers about potential risks of medications in pregnancy."

###

This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (P60AR056116); Agency for Healthcare Research and Quality and the Food and Drug Administration (HS17919 and HS10384) through the Centers for Education and Research on Therapeutics program and the Safety Assessment of Biologic Therapy (SABER) collaboration.