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P164. Safety of biological therapy during pregnancy in women with inflammatory bowel disease: Experience of a single centre

N. Machková, D. Ďuricová, M. Bortlík, E. Bouzková, V. Komárek, M. Lukáš

IBD Clinical and Research Centre ISCARE and 1st Medical Faculty, Charles University, Prague, Czech Republic

Aim: Several reports have indicated that biological therapy may be both effective and safe in the treatment of pregnant women with inflammatory bowel diseases (IBD). However, data on use of anti-TNFα compounds during pregnancy are still limited. The aim of this study was to assess the safety of anti-TNFα therapy and its impact on pregnancy outcome in women with IBD treated in a single tertiary centre.

Materials and Methods: All pregnant women with IBD who were exposed to biological therapy during pregnancy at our centre in a time period from October 2007 to September 2010 were included. Data on demographics, underlying IBD, details on anti-TNFα therapy, concomitant medication, pregnancy and newborn outcome were retrieved from medical files and supplied by patient interview.

Results: Ten women with IBD (6 with Crohn's disease and 4 with ulcerative colitis) received infliximab and 3 women with Crohn's disease adalimumab during pregnancy. Median maternal age (range) at conception was 29 years (22–34) and median disease duration 105 months (range 7–212). Regarding infliximab, 5 women were on maintenance infliximab at the time of conception (median 6 months, range 4–16 months) and continued also during pregnancy and 5 women started infliximab during pregnancy (3 women at 2nd and 2 at 3rd trimester). Totally, 5 women were exposed to infliximab at conception, 8 during 1st trimester, 9 during 2nd and 3 during 3rd trimester. Median time (range) between last infusion and delivery was 96 days (65–147).

Of 10 pregnancies, 9 ended in live births and 1 is still ongoing. There were 7 at-term deliveries with a median birth weight 3200 g (2680–3730 g). Two babies were born preterm at 35th and 34th gestational week. One in mother with active Crohn's disease, the other pregnancy was purposely ended due to maternal disease other than IBD. No congenital malformation was observed. Similarly, no perinatal complication except for one mild jaundice occurred. During a median (range) follow-up of 12 months (2–30), one child has been reported to have recurrent mild respiratory infections (vs. of atopic etiology). All other children are without any clinical immunodeficiency signs. Three pregnancies in adalimumab treated patients resulted in one at-term birth of a healthy child, one pregnancy was prematurely terminated in 11th week (patient's wish) and one ended in spontaneous abortion in 18th week in a woman with repeated abortions prior to adalimumab therapy.

Conclusion: Biological therapy in pregnant women with IBD seems to be effective and most likely helps to keep the remission of the disease during pregnancy. No adverse events in both patients and their children were observed in our series.