Su1406 Efficacy, Safety, and Demographics Factor of Adalimumab Therapy in 1693 Japanese Crohn's Disease Patients

Background: TNF alpha inhibitors are being increasingly used in IBD in women of fertile age. Studies to date have been mainly limited to case reports and case series with the largest observational cohort from 50 centres in the US. We aimed to prospectively assess the use of anti TNF treatment during pregnancy in a large European cohort. Methods: This was an observational cohort study addressing a 5 year period between 2008-2013. Female patients with IBD who had undergone anti-TNF treatment during pregnancy were identified using the IBD databases of 2 tertiary referral centres for IBD in Dublin. Patient characteristics including disease activity scores, duration, site and concomitant medications were recorded. Pregnancy outcomes including mode of delivery, miscarriage, ante and postnatal complications, age at conception and need for escalation of IBD treatment during pregnancy were also assessed. Neonatal outcomes including low birth weight, pre-term delivery, NICU stays or perinatal infection and timing of vaccines were also recorded. Data were analysed using t testing, contingency and logistic regression analyses. Results: From an IBD population of over 2,500 patients, 31 individual females who underwent anti -TNF treatment during pregnancy from 2008-2013 were identified with a total of 36 pregnancies. Median disease duration at time of pregnancy was 12 years (IQR 3-17). 85% had Crohn's Disease, 15% Ulcerative Colitis. Median Harvey Bradshaw Index pre-pregnancy was 4.5 (IQR 2-13). Median Mayo score was 1 (IQR 0-3). 57.3% received infliximab, 38% adalimumab, 4.7% certolizimab. 53.8% were on concomitant immunemodulators. The majority of patients stopped biologic treatment at the start of the third trimester. 67% had treatment reinstated in the postpartum period. Median age at conception was 30.5 (IQR 25-35). 19% had previous miscarriages. 92% had successful term pregnancies. 22% required escalation of treatment during pregnancy. 19.3% had a pregnancy complication including emergency section. 16% neonates had a low birth weight with 2 preterm deliveries and one case of NICU stay for meconium ileus. No perinatal infections were reported. 20%mothers breastfed. The majority of mothers delayed live vaccination of their children. Interestingly, there was a significant independent association between disease activity at time of conception and low birthweight (p < 0.01). There was no association between adverse outcomes or neonatal infections and anti-TNF use noted in this cohort.Conclusion: Disease control at time of conception and through pregnancy should be the main goal of treatment in this patient cohort and the use of TNF alpha antagonists to achieve this appears to warranted to improve pregnancy outcomes though definitive safety has yet to be proven.