Outcome of Pregnancy in Women Receiving Infliximab for the Treatment of Crohn's Disease and Rheumatoid Arthritis

Abstract

Data from the infliximab safety database suggest that infliximab exposure during pregnancy results in outcomes that do not differ from those in the U.S. population of pregnant women and pregnant women with CD not exposed to infliximab. No increased risk of adverse outcome was detected, however, follow-up of larger numbers of pregnant women exposed to infliximab will be necessary to definitively exclude any fetal risk.

Is safety infliximab during pregnancy in patients with inflammatory bowel disease?

“…Two registers compiled by the laboratory itself indicate that the possibility of teratogenicity is very low. The treatment register of IFX has more than 6.000 IBD patients, including 36 pregnant women who required biological treatment prior to pregnancy (10), and Centocor © 's IFX safety database includes 96 women with direct exposure to biologics (11). The Spanish BIOBDASER register informed of 11 pregnancies in 10 women treated with different anti-TNF (12) and the British register gave information about another 23 pregnancies (13), without neonatal teratogenic anomalies being observed in any of the series.…”

TNFα blockade in human diseases: An overview of efficacy and safety

“…There is a limited experience with TNFα inhibition during pregnancy [115]. From the INF Safety Database, where pregnancy outcome was available for 96 women with CD or RA directly exposed to INF before or during confirmed pregnancy, there was no increased risk of adverse pregnancy outcome [116]. An interim analysis by the Organization of Teratology Information Services did not find increased rates of miscarriage and fetal malformation in RA patients exposed to ETA or INF as compared to RA controls, but there was an increase in preterm delivery and low birth weight infants in all RA patients The British Society for Rheumatology Biologics Register in patients with rheumatic diseases exposed to TNFα inhibitors did not find an increased rate of toxicity to the fetus or mother [117].…”

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“…No specific or consistent pattern of malformations connected to exposure to biologics has been reported so far (34)(35)(36). A large collection of 131 pregnancies exposed to infliximab from the Centocor safety database reported no increased risk of adverse outcomes such as miscarriages, therapeutic terminations of pregnancy, and congenital malformations when compared with the general population (37). The OTIS (Organization for Teratology Information Specialists) registry reported 100 pregnancies exposed to etanercept, which had similar live birth rates and similar rates of major congenital malformations compared to a control group of pregnant patients with inflammatory arthritis not exposed to etanercept (38).…”