Pharmacists Can Reassure Expectant Mothers About Anti-TNF Effects

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Pharmacists Can Reassure Expectant Mothers About Anti-TNF Effects

Pregnant patients often are advised to discontinue certain medications for chronic inflammatory diseases. That might not be necessary, however, according to a new study finding that anti-TNFs aren't linked to any negative effects on pregnant outcomes. Here are more details.

DURHAM, NC – Pharmacists now have some good news to share with expectant mothers who have chronic inflammatory diseases. A new study finds that anti-tumor necrosis factor medications (anti-TNFs) appear to have no negative effect on pregnancy outcomes.

Physicians often recommend that pregnant patients discontinue anti-TNFs, especially with rheumatoid issues, according to background information in the article in Arthritis & Rheumatology.

A Duke University Medical Center-led analysis of 528 pregnancies of women exposed to certolizumab pegol (CZP), an anti-TNF approved for treatment of rheumatic diseases and/or Crohn's disease, found, however, that 85% of pregnancies resulted in live births. In addition, researchers confirmed that the rate of major congenital malformations (2%) was similar to those reported for the general population in the United States and Europe.

"In this large study of pregnancies, it appears that taking CZP during pregnancy did not increase the chances for pregnancy loss, preterm birth, or birth defects," said lead author Megan Clowse, MD, of Duke University Medical Center. "Continuing anti-TNFs in pregnancy has been recommended for many years for women with Crohn's Disease, and these data suggest that it is also safe for women with other inflammatory conditions, such as rheumatoid arthritis."

Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF approved for treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer, researchers point out.

For their study, the investigators extracted prospective and retrospective data on maternal CZP exposure from the UCB Pharma safety database through March 6, 2017.
Results indicate that, of 1,137 maternal CZP-exposed prospective pregnancies, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%). Major congenital malformations occurred in eight cases, representing 1.7% of the live births.

Most of the women, 81.2, had first trimester exposure, with 44.5% taking the drug during the duration of their pregnancy.

"This analysis represents the largest cohort of pregnant women exposed to an anti-TNF for management of chronic inflammatory diseases," study authors conclude. "Analysis of pregnancy outcomes does not indicate a teratogenic effect of CZP, compared to the general population, nor an increased risk of fetal death. The data are reassuring for women of childbearing age considering treatment with CZP."

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