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P260. Pretty baby: Successful use of anti-TNF-α therapy for Crohn's disease in pregnancy

C. Dunne, D. Keegan, A. Alakkari, D. O'Donoghue, H. Mulcahy, G.A. Doherty

Centre for Colorectal Disease, St Vincent's University Hospital, Dublin, Ireland

Introduction: Management of fertility and pregnancy in Crohn's Disease (CD) is complex. Patients with quiescent CD have normal fertility in contrast to those with active disease. When pregnancy occurs during remission a third of patients relapse (similar to that expected in non-pregnant CD patients over nine month period). In contrast, two thirds of patients conceiving during active disease will deteriorate. Maintenance of quiescent disease is preferred and risk of IBD medication in pregnancy must be balanced against risk of flares and foetal loss when medications are stopped. Biologics fall within US FDA category B concerning foetal risk, indicating no adequate well-controlled studies were conducted in pregnant or lactating women. We report experience of biologic use in pregnancy at a tertiary referral centre.

Methods: Patients receiving anti-TNF-α (infliximab or adalimumab) at time of conception were identified from prospectively maintained IBD database of 2655 patients at a tertiary centre. Prospective data on pregnancy outcomes were recorded.

Results: 15 CD patients conceived on anti-TNF therapy. 9 women on biologics had successful pregnancies, 3 other women are pregnant on therapy. The partners of three men on biologics had successful pregnancies. Average age at diagnosis of CD was 21. Of the 9 who delivered, 5 were on infliximab during pregnancy, 3 on adalimumab, one stopped after the first trimester. Mean number of infusions on infliximab was 6.4. Average duration of therapy prior to pregnancy was 2 years. All anti-TNF-α treatment was withheld in last trimester to prevent formation of antibodies in the foetus. In the men 2 were receiving adalimumab and one was on infliximab (with 20 infusions).

From nine successful pregnancies, 7 singletons were delivered (5 males, 2 females) and two sets of twin girls. 2 female and one male offspring were born to partners of men on biologics. Mean birth weight was 2.82 kg. Five babies were low birth weight (weighing <2.5 kg), the two sets of twins and one male singleton. One set of twins was conceived with the assistance of IVF while on biologics. All babies were healthy. There were no congenital malformations. Two of the three pregnant women are on adalimumab and one on infliximab. None have had complications arising from pregnancy.

Conclusion: To date, there is no convincing evidence that biologics are associated with increased risk of embryo toxicity, teratogenicity, increased pregnancy loss or other adverse pregnancy outcomes. Our experience allows us to offer some reassurance to our patients about the safety of these agents. However, uncertainty persists regarding risk of rare but serious adverse effects. Caution should be taken when anti-TNF-α agents are used during pregnancy. Potential risk should be balanced against known risks of discontinuing. Frequent updates on outcomes in treated patients is an effective way to reassure CD patients contemplating pregnancy in the future.