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Effects of Discontinuing Anti–Tumor Necrosis Factor Therapy During Pregnancy on the Course of Inflammatory Bowel Disease and Neonatal Exposure

https://doi.org/10.1016/j.cgh.2012.10.024Get rights and content

Background & Aims

We assessed the course of inflammatory bowel disease (IBD) among pregnant women who stopped taking anti–tumor necrosis factor (TNF) agents. We also analyzed levels of anti-TNF agents in cord blood samples.

Methods

We followed 31 pregnancies in 28 women with IBD between April 2006 and April 2011 who were treated with anti-TNF agents (18 received infliximab, and 13 received adalimumab) during pregnancy. We used enzyme-linked immunosorbent assays to measure levels of anti-TNF agents in cord blood collected from 18 newborns (12 whose mothers took infliximab, and 6 whose mothers took adalimumab).

Results

Among the patients taking infliximab, 12 (71%) discontinued treatment before gestational week 30; all patients remained in remission. All the patients taking adalimumab discontinued treatment before gestational week 30; two patients had relapses of IBD. There were 28 live births, 1 miscarriage among patients taking infliximab (at gestational week 6), and 2 miscarriages among patients taking adalimumab (at weeks 6 and 8); there were no congenital malformations. The mean cord blood level of infliximab was 6.4 ± 1.6 μg/mL; it was significantly lower among women who received the drug 10 weeks or less before delivery (2.8 ± 1.1 μg/mL) than those who received infliximab closer to delivery (10 ± 2.3 μg/mL; P = .02). Adalimumab was detected in 5 samples of cord blood (mean concentration, 1.7 ± 0.4 μg/mL); 1 cord blood sample from a woman who discontinued the treatment at gestational week 22 had an undetectable level of the drug.

Conclusions

Discontinuation of anti-TNF therapy appears to be safe for pregnant women with quiescent IBD. However, these drugs are still detected in cord blood samples.

Section snippets

Methods

Between April 2006 and April 2011, IBD patients with reproductive wish were recruited through outpatient clinic consultation. The consultation was performed in a standardized manner according to European Crohn's and Colitis Organisation guidelines11 by 2 physicians (Z.Z., C.J.vd.W.). Patients were recruited from the region of Southwest Holland by the physicians affiliated with the Dutch Delta IBD Study Group.

All pregnant patients were followed in a regular bimonthly outpatient clinic. In

Results

From 105 women who received the (pre)conceptional counseling, 31 pregnancies in 28 patients occurred with exposure to anti-TNF (17 to IFX and 11 to ADA). Sixteen patients were on established treatment with IFX; 13 had 5 mg/kg every 8 weeks, 1 patient had 5 mg/kg every 6 weeks, and 1 patient had 10 mg/kg every 8 weeks. One patient started the treatment with IFX because of steroid-resistant disease during pregnancy. All ADA patients were on established treatment before pregnancy; 9 patients used

Discussion

In this study, we evaluated the impact of discontinuation of anti-TNF agents during pregnancy on the course of IBD. We found that discontinuation before gestational week 30 in patients with quiescent disease is feasible and safe in terms of disease control. In addition, this approach helps to reduce the neonatal exposure.

This latter finding needs cautious interpretation. First, IFX can be detected in children for several months after delivery,8 which may interfere with proper response to

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Conflicts of interest These authors disclose the following: Zuzana Zelinkova received consultancy and lecture fees from MSD and a consultancy fee from Abbott. C. Janneke van der Woude received consultancy and lecture fees from MSD and Abbott and a consultancy fee from Shire. The remaining authors disclosed no conflicts.

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