Study: No New Safety Concerns With Biosimilar Infliximab in Pregnant Patients

Anti-tumor necrosis factor (anti-TNF) therapy used to treat pregnant patients with inflammatory bowel disease (IBD) has been linked with lower birth weight, shorter gestational term, and in some studies, more frequent birth defects or spontaneous abortion.

Although the benefits of originator infliximab have been deemed to outweigh the potential harm during pregnancy, in a recent observational study, researchers looked to evaluate whether biosimilar infliximab therapy was associated with any new safety risks in the same population.

The observational study was conducted among 20 pregnant women who were treated with biosimilar infliximab. Researchers compiled data on disease activity, prior treatment, and newborn outcome, as well as blood levels of the anti-TNF agent.

Of the 20 women studied, 16 had Crohn disease, and 4 had ulcerative colitis. Patients’ mean age was 28.7 (±4.1), and 55% (n = 11) were pregnant for the first time.

At the time they conceived, 30% (6) of the patients had active disease, and 65% (n = 13) were in remission. One patient was newly diagnosed with acute severe colitis after having conceived. Other than the last patient, all women had already received infliximab treatment prior to pregnancy.

Researchers recorded 19 live births, with a mean weight 3305 g (±493 g), 18 of which were at term. One was both preterm and had a low birth weight. One pregnancy was spontaneously aborted.

In addition, researchers found that disease activity at conception was associated with both lower birth weight; mean birthweight was 3549 g (±392 g) in the remission group versus 2921 g (±390 g) in the active disease group, respectively (P =.0043).

Although researchers note that findings were limited by the small study size, no new safety concerns were found in pregnant women treated with biosimilar infliximab. In addition, according to the study authors, this was the first report of pregnancy outcomes in women treated with biosimilar infliximab.

Reference

Kolar M, Duricova D, Bortlik M, et al. Pregnancy outcomes in women with IBD treatment with biosimilar infliximab. Presented at the European Crohn's and Colitis Organisation Congress 2018 meeting, February 14-17, 2018; Vienna, Austria. Abstract P614.

ecco-ibd.eu/publications/congress-abstract-s/abstracts-2018/item/p614-pregnancy-outcomes-in-women-with-ibd-treated-with-biosimilar-infliximab.html