Good News for Pregnant Women on Biologics

January 16, 2015

Pregnancy outcomes for women taking medications for rheumatic disease offer reassuring information. Also, details about forthcoming labeling changes for medications used during pregnancy, including biologics.

Østensen M, Andreoli L, Brucato A, et al., State of the Art: Reproduction and Pregnancy in Rheumatic Diseases. Autoimmun Rev. 2014;Dec 30.  doi: 10.1016/j.autrev.2014.12.011. [Epub ahead of print]

Tumor necrosis alpha (TNFα) blockers hold promise for maintaining remission in pregnant rheumatological patients, and treatment may continue through the first half of pregnancy, according to a new review.

Recent studies show adalimumab is not associated with an increased incidence of birth defects, preterm deliveries, or small birthweight babies, these authors report in their overview of research first presented at the 2014 International Conference on Reproduction and Pregnancy and the Rheumatic Diseases in Trondheim, Norway.

Four TNFα inhibitors – adalimumab, etanercept, infliximab, and certolizumab -- can cross the placenta. Etanercept and certolizumab appear to have lower levels of placental transport, the authors say.

Preliminary analysis of an ongoing study examining the outcomes of children exposed to anti-TNFα drugs in utero during the first 24 months after birth and indicates good birth outcomes and normal growth. According to the report, there are no significant differences between exposed and non-exposed children born to mothers with chronic arthritis.

“Pre-conceptional counseling and interdisciplinary management of pregnancies are essential for ensuring optimal pregnancy outcomes,” the authors conclude.

The multi-national review of pregnancy in rheumatic diseases comes as the US Food and Drug Administration (FDA) institutes clearer labeling of drugs for use during pregnancy and lactation to replace its A, B, C, D, and X categories.
The FDA announced in December that reproduction risks associated with biologics and other medications will be covered in three new subsections:

Pregnancy: dosing, potential fetal risks, clinical considerations, other information regarding prenatal  use, and registeries gathering data on adverse effects during pregnancy (in a section called Labor and Delivery).

Lactation (formerly “Nursing Mothers”: amounts of drugs that may reach breast milk and potential effects on the child.

Females and Males of Reproductive Potential: information on pregnancy testing, contraception, and infertility as they relate to specific medications.

These changes will go into effect on June 30, 2015, for all new prescription drug submissions, and will phase in gradually for already-approved prescription drugs. Labeling for over-the-counter medicines will not change.