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P605. Adalimumab (ADA) and infliximab (IFX) therapy during pregnancy in IBD: a prospective assessment of outcome, safety and cord blood levels

S. Traussnigg1, A. Eser1, C. Primas1, P. Papay1, C. Gratzer1, S. Angelberger1, A. Mikulits1, W. Reinisch1, M. Trauner1, H. Vogelsang1, G. Novacek1, C. Dejaco1, 1Medical University Vienna, Internal Medicine III Gastroenterology and Hepatology, Vienna, Austria

Background

Disease activity is a major risk factor for gestational complications in IBD. Data on IFX therapy during pregnancy have not shown adverse events, however data on ADA are still scare. Anti-TNFα cord blood levels have been assessed in few newborns with IFX, suggesting discontinuation of treatment prior to the third trimester of pregnancy to avoid neonatal exposure. So far few data are published on ADA fetal cord blood levels, guiding adequate cessation prior to birth.

Methods

We aimed to evaluate safety and impact of anti-TNFα therapy on fetal development and pregnancy outcome as well as to assess ADA cord blood levels after discontinuation at different GW. All women with Crohn's disease (CD) or ulcerative colitis (UC) at our tertiary referral center treated with anti-TNFα therapy during pregnancy were included from Aug 2003 to Nov 2012. Data include disease activity, complications and since 2011 anti-TNFα maternal- and newborn's cord-blood levels.

Results

A total of 14 pregnancies in 13 women with IBD were included (median age 26 years; 13 CD, 1 UC). Patients received either ADA (n = 9) or IFX (n = 5). Median disease duration was 68 months (12–218). At time of conception all women received anti-TNFα treatment and 9/14 women were in clinical remission. Therapy was discontinued at median GW 24 (2–37); 1 patient received ADA during the entire pregnancy. Seven patients remained in remission during the whole pregnancy. Three out of four new flares developed after cessation of anti-TNFα. Concurrent medication was cortisone (n = 5) and 5-ASA (n = 8). Four women experienced new flares within one week after birth. All completed pregnancies (n = 13; 5 IFX, 8 ADA) ended in live births at median GW 40 (36–42). Median birth weight was 3175g (1960–3930g). No complications like congenital malformations or perinatal complications occurred. So far, ADA cord blood levels could be assessed in four newborns. After discontinuation of ADA in median GW 27 (24–30) cord blood levels of median 0.95 µg/mL (0.36–1.30) were detectable, which all were higher than the available levels of the mother's at median 0.9 µg/ml (0.33–0.99). During follow-up of median 6 months no clinical signs of immunodeficiency were observed.

Conclusion

Anti-TNFα therapy during pregnancy in women with IBD appears to be safe. However, our first data on ADA cord blood levels in newborns emphasize neonatal antibody exposure, suggesting a similar early cessation of ADA therapy, as recommended for IFX.