Abstract
Background: In pregnant women with inflammatory bowel disease (IBD), exposure to biologic therapy, especially anti-TNF antibodies, has not been associated with adverse events. However, data on the efficacy and safety of biosimilar infliximab (IFX) in this particular population of IBD patients are lacking.
Methods: This retrospective study included 20 women treated with biosimilar IFX (CT-P13) during pregnancy for whom information about pregnancy outcome was available. Data on disease activity, treatment, and pregnancy and newborn outcome were recorded.
Cord blood levels of anti-TNF were measured by ELISA. Results: Twenty pregnant women (16 with Crohn's disease and 4 with ulcerative colitis) with a mean age of 28.7 +- 4.1 years were included, 55% of whom were primigravidae.
The mean disease duration at the time of pregnancy was 6.0 +- 5.3 years, and 70% of the women had a history of perianal disease. At the time of conception, 30% had active disease and 65% were in remission; one of the women was newly diagnosed with acute severe colitis after conception.
Besides this patient, to whom IFX rescue therapy was administered during the first trimester, all women had already been treated with IFX before becoming pregnant, with a mean treatment duration of 2.3 +- 2.7 years. There were 19 live births (mean weight, 3,305 +- 493 g), 18 at term and 1 pre-term (with a low birth weight).
One pregnancy ended in spontaneous abortion. Disease activity at conception was associated with lower birth weight (3,549 +- 392 g for those in remission vs. 2,921 +- 390 g for those with active disease; p = 0.0043).
Cesarean section was performed in 70% of the women, 79% of whom had a history of perianal disease. No perinatal complications and birth defects were reported, except for a single case of cleft palate.
Conclusion: To our knowledge, this is the first report of pregnancy outcomes in women exposed to biosimilar IFX. Under the constraints inherent in the limited sample size, no new safety concerns have so far arisen.